ABOUT THE NOW DEFUNCT FRENCH PIP IMPLANTS
WHAT YOU NEED TO KNOW, MR TURTON’S SPECIALIST ADVICE AND THE LATEST NEWS
(Please see the end of this document for the latest news, the statement made by the Department of Health and the Association of Breast Surgery, and the interim report by Sir Bruce Keogh, NHS Medical Director and the European Union’s expert report on PIP implants that was released on the 1st February 2012)
Mr Turton never used PIP breast implants in his career. They were a product that he was uncomfortable with when they were being marketed in the UK. Mr Turton does not have commercial ties to any breast implant companies. He will use his expertise to help you navigate the implant market and select the best implant for you from the approved manufacturers: At the point of sale, all meet the necessary standards of a class 3 medical device. However, history has demonstrated that problems can and do arise periodically with manufacturing processes or are identified from post-market surveillance, and it is always possible in the future that an implant that you have had placed might be suspended from subsequent use or withdrawn entirely by the certifying body and regulator. Implant safety from Mentor is reported in comprehensive after sales studies and supported by FDA approval. Companies selling implants in Europe require CE approval and are now subjected to more rigorous checks that they conform with regulations. Allergan textured implants are not in use as their CE mark was not renewed in 2018. The MHRA clearly state that no routine removal of Allergan implants that are already in patients is needed, unless there is a problem that requires it. But existing stocks of Allergan implants have been withdrawn from the market and removed from hospitals.
What were the French PIP Implants?
The PIP implants were distributed in the UK by ‘Clover Leaf’. Clover Leaf were the marketing and distributor of these implants to hospitals and surgeons. Clover Leaf fulfilled the ordering process. Patients who had PIP implants placed by large commercial organisations or smaller clinics run by individual surgeons were left with a great deal of anxiety. Some patients still have the implants and await surgery. The PIP implants were manufactured in France by Poly Implant Prothese (PIP). It was shut down and the company liquidated in March 2010. Jean-Claude Mas, the founder was convicted of fraud and given a 4-year prison sentence in France. He has since died, and this was reported in the news in 2019.
The background to the scandal is that the manufacturer PIP obtained a European CE Mark indicating that it complied with the relevant EU regulations. This was overseen by TUV Rheinland – a German commercial organisation responsible for undertaking the necessary safety and regulatory checks required for a CE Mark. Once a medical device has a CE Mark it can be placed on the market in any EU member state. Under these circumstances, the UK regulator (the MHRA) becomes responsible only to investigate adverse incidents as part of a post-market surveillance strategy. Their advise to surgeons on reporting of adverse events is available to download here. Surgeon’s may also access the form for the reporting of the adverse event to the MHRA as a free PDF download here, (word document version here) or the PIP Explanation Form Here.
The PIP company went into liquidation at the beginning of 2010 with reported losses in excess of 9 million Euros. Jean-Claude Mas, a former medical sales rep, was the company’s founder. The French PIP implants were marketed as being good quality and were also approved by the French regulatory authority (AFSSAPS) as conforming to expected standards. They were distributed in the UK by a company called Clover Leaf. Concerns were first raised in France as the higher rupture rate became apparent. The UK regulatory agency was also warned by concerned surgeons. The industrial grade silicone used in the French PIP implants was five times cheaper to manufacture than the approved medical grade version. It has been reported that some recalled PIP Breast Implants were last year ‘rebranded’ and sold under the name M-Implants by a Dutch firm called “Rofil Medical” – These were apparently never used in the UK. Any patients who had breast augmentation abroad need to be aware of this as cosmetic surgery tourism destinations around Europe, may have used them. This has been reported to have taken place in Estonia for example. PIP also made testicular silicone implants, male chest implants and buttock silicone implants which were exported to Brazil.
Full details of the Special Reuters Report on PIP Implants released on the 2nd February detail the background to the whole PIP scandal. This is linked in the news section towards the end of this document. The Chief Medical Officer for England has issued GPs and surgeons with specialised guidance on how to check and care for women with PIP implants, (PDF version available here).
During what period of time were these French PIP implants used?
They were used by a limited number of surgeons only and principally in the Harley Medical clinics. The majority of UK Breast Surgery Specialists (members of the Association of Breast Surgery (the ABS) never used them. The period of use was from around 2000 until their withdrawal from the worldwide market in March 2010 (there is some uncertainty as to whether the criminal activities of PIP may have involved them using the non-medical gel in PIP implants prior to them obtaining the European Kite mark in 2001). The French PIP implants have been used predominantly in cosmetic clinic chains such as Harley Medical (they implanted PIP implants into over 13000 women), and Transform Medical (they implanted PIP implants into over 4000 women). There are an estimated 47000 to 52000 women in the UK with these implants. In other countries estimates are as follows: 30000 in France, 25000 in Brazil, 9000 in Australia, 5000 in Sweden, 4000 in Italy, 2000 in Czechoslovakia and 1500 in Ireland. It is estimated that 300000 implants were sold world wide.
Mr Turton never used PIP implants as he always chose the manufacturer based on what was known at the time to be the best quality and safety record, rather than just the product price. The PIP implants were cheap and he felt that they were an inferior quality, without the necessary assurance to back up their marketing statements. There was no established track record on complication rates from PIP implants and as a specialist Mr Turton could not ever justify using them in his patients.
At the time of Andrew Lansley’s announcement on the 6th January 2012, Harley Medical Group and Transform who between them had fitted the faulty implants into the majority of UK women had made no pledge to match that made by the Secretary of State for Health, that any implanted by NHS hospital would be replaced free of charge if that was what the women wanted. Transform fitted most of their PIP implants prior to 2005. Noticeably they continued to use them between 2006 and 2010 when they actually recorded having to perform more PIP implant removals (133 patients) than placements (110).
Which Serial Numbers of PIP Implants are affected?
Leaving aside the potential for the sale of some PIP implants prior to 2001, we know that the non-approved silicone gel implants were manufactured and distributed principally between 2001 and 2009. These have the following model numbers:
•IMGHC-TX
•IMGHC-MX
•IMGHC-LS
But note: There is suspicion that PIP and ROFIL implants that were manufactured before 2001 are also affected and are prone to a higher rupture rate and therefore silicone leakage. Therefore, all women with PIP implants should see a specialist.
What was the problem with French PIP implants?
There was a major problem with them in that the silicone gel inside the implant was of a non-medical grade. This was used by PIP instead of medical grade silicone. The PIP non-medical grade gel cost €5 (£4) a litre while the authorised American gel (Nusil) was €35 a litre. The PIP implants were made with 75% non-authorised gel and 25% Nusil, Mas allegedly told police. This is a clear case of fraud as PIP had declared on the device design file that they were using a medical grade silicone, and hence their implants were approved on an erroneous basis by the French regulator. This non-medical grade silicone is composed of raw silicone materials, the sort you might find in a mattress.
They may include chemicals like Baysilone, Silopren and Rhodorsil which are reportedly found in fuel additives and rubber tubes.
If the silicone leaks out it comes into contact with surrounding tissues where it has an irritant effect causing inflammation. The PIP implants are reported by the French device regulatory agency to have had a rupture rate of up to 10% in the first year of implantation. In addition a separate phenomenon of leakage of the gel of intact implants has been noted. This means that the silicone could pass out of the containing elastomer shell into the surrounding area even when the implant has not ruptured. The occurence of silicone bleed is thought to occur more readily due to the impurities in the gel. Non medical grade silicone contains lots of volatile low molecular weight silicones which damages the shell causing more fragility and more bleeding. It also probably passes into the tissues once it has leaked more readily as it is of a low molecular weight. In the French vigilance study as reported by the regulator this may occur in up to 11% of cases. The FDA declined to approve a saline PIP implant in 2000 based on a lack of safety data and subsequently issued a warning that they had found “11 deviations from good manufacturing practices” during a visit to the PIP factory. Poly Implant Prosthesis (PIP)/Clover Leaf Products Ltd were made to voluntarily withdraw a previous Hydrogel implant in 2000, by the UK regulatory authority over concerns. 4000 UK women had these implants from 1994. The company in France soon began to manufaturer its own industrial silicone in Toulon, France, in early 2000. It is reported in the Telegraph newspaper that PIP would purchase batches of industrial silicone from Belgium and combine them with batches from America to create it’s own cheap formulation. When inspectors made checks at the PIP plant, the industrial silicone was hidden so that the fraud went undetected. The two silicones were so different that it is reported that the industrial silicone would behave like a soapy water, in contrast to the thick medical grade gel that doesn’t run. The MHRA issued a device alert in relation to PIP implants in February 2011. This can be downloaded here.
What has Mr Turton noted in the patients who have come to him for removal of French PIP implants that were placed by other surgeons and other centres?
Mr Turton has had many patients from across the UK who have come to him to replace their PIP implants. Some of these women are just very worried and can’t live with the uncertainty of the situation or don’t want to wait until their implant might cause problems. A small number have been less fortunate and have had nasty symptoms and dramatic changes to their breasts. One lady had a grossly swollen breast that was several cup sizes bigger than normal. Her implant had ruptured and the gel had escaped causing a profound inflammatory reaction with fluid accumulation around the implant. In addition there was very clear spread of the silicone into the deep breast tissue in a highly unusual manner: The breast had multiple locules of a runny/gloopy silicone gel such that it looked like a Swiss cheese or honeycomb on the inside. One tract of runny silicone was noted to extend all the way through her upper breast and further; it extended under her collar bone and into the root of the left side of her neck. This was only found by Mr Turton’s careful intra-operative dissection.
Other women have been found to have painful swollen glands under their armpit (lymphadenopathy) as the silicone gel had spread through the lymphatic pathway to the regional draining lymph nodes. Similar findings are reported by other specialists- in an early letter to the British Journal of Plastic Surgery in 2007, a concerned surgeon reported similar findings of a catastrophic rupture after just 3-years, to warn his colleagues.
Mr Turton has also seen many cases where the patients have just had silicone bleed present causing either no symptoms, minor irritation or spread to the local lymph nodes. He has also seen differences in the silicone gel in different PIP implants- in some cases it is more runny, in others it can look more like conventional high cohesive gel. One lady operated on at the beginning of February 2012 had completely different colours of gel in one PIP implant compared to other PIP implant- one side was very yellow, and the other very white. This likely reflects changes in the composition of the gel that was used, or the reaction of the implant to local tissue fluids. This lady had worrying swollen lymph nodes in her neck and arm that mysteriously appeared 6-months earlier and she felt tired and unwell, only to recover gradually before she noted the lymph nodes appear again under her arm as smaller hard peas. These were confirmed on ultrasound to be silicone engorged lymph nodes, and she therefore came under Mr Turton’s care for removal of her implants and redo breast augmentation with another brand of implants. As well as finding both PIP implants to be completely ruptured and having very different appearances of the gel, on one side there was a milky creamy fluid surrounding the implant.
Images of problems from French PIP implants that Mr Turton has removed.
Leaking PIP implant removed by Mr Turton, Specialist Cosmetic and Oncoplastic Consultant Breast Surgeon. This shows runny industrial grade silicone oozing from the defect on the right side of the implant
Picture of a ruptured PIP implant, removed by Mr Turton, Specialist Cosmetic and Oncoplastic Consultant Breast Surgeon. Another example showing rupture of the PIP implant shell and leaking gel.
Picture of a ruptured PIP implant – leaking gel; Removed by Mr Turton. On the right the shell is completely fractured but the gel is cohesive. On the left, the implant is intact.
Pictured below are two French PIP implants that we removed due to pain in the breasts. The patient had undergone her breast enlargement surgery at Harley Medical. She developed swollen glands and pain. When we removed her implants Mr Turton found a very yellow coloured gel in one ruptured implant and a very white gel in the other ruptured implant. Although the absorption of plasma into the implant may account for some colour difference, this was very unusual given both were ruptured and of strikingly different colours. The different coloured gels may reflect that this patient has PIP implants with different industrial silicone in each. Jean-Claude Mas had reportedly admitted that he experimented with the mixtures. This patient’s case was been reported to the UK regulator, the MHRA. The other findings in this case were that surrounding the yellow implant was a milky oily fluid in the breast cavity. It was on this side of her body where the lymph nodes had become swollen indicative of migration of the silicone oils.
Picture of the sample of oily milky-coloured industrial silicone gel retrieved from the breast cavity of a patient who had a ruptured PIP implant. Surgery by Mr Turton, Specialist Cosmetic and Oncoplastic Consultant Breast Surgeon
Picture of a removed lymph node – full of silicone (lymph node should be less than 1cm, this one measured 6 cm). Surgery by Mr Turton, Specialist Cosmetic and Oncoplastic Consultant Breast Surgeon
Unusual appearance to the peri – PIP implant capsule so tissue sample taken as a biopsy by Mr Turton for histology. The capsule is normally a smooth structure, but here it is warty in texture and uncharactertistic of the normal appearance. This may be due to chronic inflammation or the onset of synovial metaplasia, a process that can occur with implant leakage. The message is: If the capsule looks abnormal at the time of PIP implant exchange, the breast surgeon should biopsy it for histology.
There is a subtle blotchy red skin rash shown in this picture. This patient has several identical skin rashes that are 6 to 7cm and variegated that appeared 3 years ago at the same time as lymph node enlargement under her arm pit (axillary lymphadenopathy). She was never referred for investigation. She attended to see Mr Turton recently when she learned she had PIP implants placed by her previous surgeon. Mr Turton diagnosed that both PIP implants have leaked silicone extensively into her armpit lymph nodes. As the rash appeared at the same time 3 years ago as when she first found the lymph nodes to have enlarged it is very possible that the two are linked. She has no other symptoms. This case has been reported by Mr Turton to the MHRA as a possible sytemic complication of PIP implant rupture. Mr Turton will remove her implants after he completes further tests.
Pre-operative picture of a patient with leaking PIP implants showing breast distortion and swelling.
Pre-operative picture of a patient with leaking PIP implants showing breast distortion and swelling.
Post-operative view of same patient after Mr Turton removed her leaking implants, carried out remedial surgery and then performed a redo breast augmentation with Allergan implants achieving a very succesful outcome.
Do the French PIP implants cause breast cancer?
There is no definite evidence for this, and both the UK, the European and Australian agencies are all in agreement that there is no breast cancer link. If there was one it would be so low as to be negligible in comparison to other things in life. An uncommon lymphoma, called Anaplastic Large Cell Lymphoma (ALCL) is thought to have been responsible for the death of one French lady who had the French PIP implants. ALCL associated with implants is uncommon but it can occur with any manufacturer’s implants. See my section on ALCL on my website for further information. The standard type of breast cancer that affects around 1 in 8 women in the UK during her lifetime is called invasive ductal or lobular carcinoma. This rate is the same in women with implants and those without. Data shows that it is not more frequent in women with implants, and this is well established and confirmed by several independent regulatory organisations in the UK, Europe and USA.
What other tests have been done on the French PIP implants?
The French, Australian and UK regulatory authorities have performed independent tests to check the toxicity of the non-medical grade silicone. The French tests showed that there was no cellular toxicity, but there was a definite irritant behaviour to tissue causing inflammation. They also showed reassuringly that there was no “genotoxicity”. This means the gel wasn’t damaging the DNA inside the cell. This is important as such damage would raise concerns over cancer. As it was OK, it means there was never likely to be a link to cancer. They also did a mechanical enquiry and found that the device failed in the elongation of shell test, which causes rupture. This indicates the implant may be more fragile.This would also fit with the finding that Poly Implant Prosthese ceased with one of the outer layers of the implant after 2005. The Australian regulator, the TGA, came to similar conclusions:
- There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman’s condition by her surgeon or other treating physician after consultation.
- PIP silicone gel filled breast implants are reported to have a higher prevalence and incidence of implant ruptures than other silicone breast implants, and that ruptures also tend to occur earlier in the implant life than is the case with other implants. These reports indicate that the shell/patch or the manufacturing process for a number of batches of PIP implants was of inferior quality, which may be a reflection of variations in the manufacturing process. The risk of implant rupture increases with implantation time. Quantifying the actual increase in failure rate is problematic because the failure rates of non-PIP implants are not well documented.
- Several cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants. This has led to investigations into the possible toxicological consequences of their release from damaged PIP implants. It has become apparent that these chemicals are commonly present in the bodies of women even without breast implants. This is a consequence of the widespread use of siloxanes in many domestic products. Cyclic siloxanes D4, D5 and D6 are non-toxic and not irritant in standard tests.
What does this all mean?
In essence the PIP implants do not conform to normal silicone implants. The UK women with French PIP implants were rightly very worried. They can be reassured that in the absence of symptoms that there is unlikely to be any immediate health concern. If the implant ruptures then the implants should certainly be removed or exchanged promptly. Imaging surveillance, preferably an MRI, should be considered in women without symptoms who have decided not to remove their implants to screen for rupture. Even in the absence of symptoms, Mr Turton still recommends a breast specialist consultation, and removal in most cases as the norm rather than the exception- see below to understand why-
If I don’t have symptoms from French PIP implants should I have them removed or exchanged?
The UK regulator, the MHRA, were initially saying there was no need for this. The French and German regulatory authorities had already said that all French and German women with these implants should have them removed as a precautionary measure! The French Government appears to be supporting the cost in some circumstances but this was to be clarified. The UK Secretary of State for Health had said initially that the routine exchange of all faulty implants was not generally necessary in the UK, but updated information was provided on Friday 6th January 2012 (see news section below) after he ordered an expert review. The initial position was that there are risks of surgery that have to be balanced against the risk of problems from the implants. The position now is that the UK Government will not routinely be supporting the costs of revisional surgery, except for NHS patients who had them placed through the NHS (a small proportion of UK women had PIP implants placed as part of breast reconstructive surgery on the NHS).
The patients who had PIP implants in clinics like Harley Medical or Transform are expected to seek their redo surgery from those companies. If those companies refuse then the NHS will now support those patients as a fall back position, but only to remove the implants for them, if deemed clinically necessary by a specialist. The NHS will not fund free redo breast augmentation if the implants were orginially placed in the private sector. The onus has been put squarely on the orginal clinic to support their patients. The large private hospital groups – the Nuffield and Spire Hospital groups – had already said they would fully support the small number of their patients and perform free of charge removal of PIP implants and replacement.
It had been uncommon for patients under those providers to have received PIP implants, so relatively few patients were affected. However, Transform and Harley Medical have made varying statements, and there are literally thousands of women who received PIP implants from them who were left in a worrying position. They faced additional expense if they wanted replacement implants.
Women who had problems from PIP implants but were unable to afford surgery in the private sector were allowed to have the implants removed on the NHS (after specialist breast surgeon review), but the position is clear that they can not have them replaced. Mr Turton can perform revisional surgery and redo surgery in the private sector and conduct all aspects of surgery, including removal of PIP implants, checking for leakage, checking for capsulation and removing them. Redo augmentation with FDA approved implants can be performed. Mr Turton conducts this surgery for patients with PIP implants at the Leeds Nuffield, the flagship private Nuffield hospital in the UK, or at Spire hospital in Leeds. He can also (on instruction from a solicitor) provide full medico-legal reports.
In all patients with PIP implants he will take before and after patient photos, and photos of the implants once removed (they usually cannot be retained for the patient) and collate any evidence of complications. Mr Turton is a breast surgery expert and this is important for all patients having this sort of revision. In an interview last year with Cosmetic Surgery Today, Mr Turton details the sort of assessment a specialist provides.
Mr Turton’s personal expert breast specialist recommendation to women with the French PIP implants:
If you have any of these symptoms, get an urgent check up.
- lump or thickening in the breast
- lumpiness or swelling in the area around the breast, or in the armpit (may feel little nodules- like peas or more obviously enlarged glands like a kidney bean or even bigger)
- change in shape of the breast
- deflation of the breast
- redness or itching, or appearance of a rash
- tenderness of the breast
- swelling of the breast
- pain or sensitivity
Ask your GP to refer you to the NHS One-Stop Breast Clinic. If necessary you should see a specialist breast surgeon who does this sort of surgery all of the time (usually a reconstructive breast surgeon, oncoplastic breast surgeon, who will be a member of the specialty “Association of Breast Surgery”) as he/she is best placed to assess you, will know about the problems that they are looking for, can investigate you appropriately and advise you accurately on treatment. However, in the NHS, you may be assessed by a junior member of the breast team or in a slightly less specialised centre, but if you are still concerned you could ask to be referred on to a bigger centre.
For private patients, travel to Leeds is very straightforward and the Leeds Nuffield Hospital is just a 5-mins walk from the Leeds train station.
The earlier message from the MHRA on routine imaging of PIP implants was that it is not necessary: There is no indication for any routine action in the form of explanation or ultrasound investigations. Discussions have been held with Dr Erika Denton, Consultant Radiologist, National Clinical Director for Imaging, Department of Health on the question of radiology of the breast and PIP implants. Her advice is that “routine ultrasound is not indicated since it is not evidence-based.” Mr Turton’s personal view is that each patient should be assessed on their own merits and a blanket statement such as this although reassuring, is difficult to apply universally.
If either PIP implant has ruptured, then both implants should both be removed promptly. If there is fluid around the implant, they should also be removed promptly unless there is another sound explanation for such an experience. If there is capsular contraction, then the PIP implants should be removed and the capsule carefully dissected from the breast tissue and also sent to a pathologist for review to exclude some uncommon but more sinister changes that can occur to this tissue. If there are painful nodes in the armpit, this should be assessed as to the cause. It would be very likely that this was due to silicone lymphadenopathy or reactive lymphadenoapthy caused by leaking PIP implants or ruptured PIP implants. Remember that other problems can occur in the breast or the lymph nodes that are unrelated to the implants and when 40,000 UK women have these implants it is inevitable that this will be the case for some women. Hence, a check up with a breast specialist is highly recommended.
If you have no current problems with your PIP implants what should you do? Unless you yourself are 100% confident in these implants, Mr Turton’s personal advise is that you should probably have them removed but you need to weigh the pros and the cons, the risks and the benefits, the sequelae, the possible alternatives…. and then to make a decision.
There has not been any form of robust scientific data collection in the UK to ensure an accurate record of the problems from PIP implants. Simply asserting that the figures in the UK on rupture are lower than in France holds no weight as a result. The bottom line is that the implants can cause problems even when they haven’t ruptured. Mr Turton would therefore recommend that all women with PIP implants that were previously placed through the NHS see their GP and request referral to a breast specialist within the NHS. You should have a clinical examination by a consultant breast surgeon who also uses implants as part of their work (usually a reconstructive breast surgeon/oncoplastic breast surgeon). You would have an examination of the lymph nodes under your arm pit (the axilla). If you have any symptoms or clinical signs you should have an ultrasound scan to assess the implants and your breasts. This at the very least will give you additional immediate imformation as to whether there are any concerns. But USS and even breast MRi lack sufficient sensitivity to exclude rupture in all cases.
If your implants were placed by a cosmetic clinic, you should seek their services for investigation and removal/exchange of the implants. If that clinic refuses to give you care, there has been authorisation for the small number of patients that are likely to be in this scenario that the NHS route will be available- but this is currently only to assess, investigate and where desired/agreed, to remove the implants- the NHS is not permitted to carry out redo augmentation with new implants. Some NHS centres may be able to make arrangements for patients to fund the difference and have re-augmentation, but this is not standard and unlikely at present.
Reasons to remove implants even if no symptoms:
1. There is non-medical grade raw silicone components in the implants, and no one knows for sure if there could be long term health risks from this. 2. If the silicone is outside of the implant it can affect adjacent or remote tissues if left there for long enough (inflammatory reactions). Although toxicology tests (French regulator’s statement of additonal tests is available to download here) and cancer tests have proved to be negative so far, according to the regulator, no guarantees can be offered. The implants may leak silicone without rupturing, and a normal ultrasound examination, cannot therefore, exclude this possibility; the only way to know is surgical removal. 3. There has been no robust data collection in the UK. There has been no compulsory recording with the regulator when implants have been removed or exchanged for any reasons, even though that is likely to change now. But this does amount therefore to a precautionary stance to remove the implants in the absence of robust data. Nonetheless, they should never have been used in the patient’s concerned in the first place.
If you have private health insurance you can ask your GP if they can refer you if you have symptoms, but check with your insurer that you are covered. Mr Turton does take such referrals. If you want to be seen privately for this assessment but don’t have medical insurance, you will have to pay the consultation costs and any costs related to breast imaging (ultrasound of breast implants costs around £200 usually).
Please contact Mr Turton’s secretary Victoria Short to make any further enquiry: Victoria.Short@nuffieldhealth.com
OPINION from the Scientific Committee on Emerging and Newly Identified Health Risks (The opinions of the Scientific Committees present the views of the independent scientists who are members of the committee)
Mandate
To determine whether implanted PIP breast implants could give reasons for concern from the health point of view when compared with state of the art implants, taking into account their structure, composition and detected defects (e.g. low quality silicon, single envelopE instead of double envelopE) and the risk of rupture and oozing they may present;
General response
The data available presently on PIP silicone breast implants is necessarily limited at this stage, as the PIP manufacturer did no clinincal or epidemiologic research. So, the evidence on failure rates and complications related to PIP silicone breast implants are based on case reports. The large number of breast implant studies conducted to date and reported in the literature did not for the most part examine data by manufacturer. The focus of attention in this initial response is on the following aspects:
− Physical and chemical properties of the PIP silicone breast implants, where available;
− Findings of the effects of PIP implant contents in the required animal tests, where available;
− Reports of incidents of PIP implant failures, where available.
Physical and chemical properties: The more recent PIP silicone breast implants, in common with those of other manufacturers, comprise a single envelope/shell. The implants consist of an outer shell filled with a gel. In common with those of most other manufacturers, they were manufactured using the polymer polydimethylsiloxane, also known as silicone. The chemical reaction resulting in gel formation must be controlled because it governs the degree of crosslinking. The more variable this reaction is, the greater the variation of the content of volatile and/or low molecular mass components in the implant (gel and shell) is likely to be. Use of industrial grade silicone along with a lesser control of the cross linking process appears to be associated with a higher content of low molecular weight components. As a consequence of the migration of these components it is reasonable to conclude that the shell might be weakened and that components could leak into the surrounding tissue.
Tests conducted by the French Authorities on the physical integrity of a sample of PIP silicone breast implants indicated weaknesses in PIP shells not found in other commercially available implant. Findings in Toxicity tests: To date few studies aimed at evaluating the toxicity of the contents of PIP silicone implants so far have been conducted using tests specified for assessing the safety of Class III medical devices. The tests that were performed are designed to assess cytotoxicity, irritancy and genotoxicity. Medical grade silicone gels give negative results in these tests. In the case of the contents of the PIP silicone implants, tests for cytotoxicity and genotoxicity were negative.
However, an in vivo test for irritancy was positive. This indicates the potential for inducing local irritancy when the silicone gel is released form the implant. The extent will depend on the amount released, the duration of exposure and other local conditions. The implications of this positive result for irritancy for women with PIP silicone implants are currently uncertain and require further investigation.
Incident reports: There are cases reported suggesting that PIP silicone breast implants may have a higher failure rate in the first few years after implantation compared with those from other breast implant manufacturers. There are also a few case reports that ruptured PIP silicone implants may be associated with a higher incidence of swollen and painful lymph nodes.
The limited and selective clinical data and the absence of epidemiologic data on PIP silicone breast implants provide insufficient evidence to warrant a conclusion that women with PIP silicone breast implants have a greater risk to their health than women with breast implants from other manufacturers. However, studies among women with 58 standard-quality implants (including patient with ruptured implants) have shown that the risks of cancer and connective tissue disease are not increased among women with such implants. The limited available information, allied with the findings from tests of the physical and chemical properties of the shell and silicone and of the in vivo irritancy test, raises some concerns about the safety of PIP silicone breast implants as the possibility of health effects cannot be ruled out.
The SCENIHR is asked to identify the generic risks and benefits of various actions that might be taken to address these concerns. As noted above there are obvious difficulties in providing scientifically based advice because:
− Over time, regardless of the manufacturer there will be an increased failure rate of the implants;
− For many women it is uncertain whether their breast implant is a PIP manufactured implant;
− Simple clinical examination alone is unlikely to identify those patients with a leaking/ruptured implant;
− Many such implants have been inserted by surgeons who are not qualified in plastic surgery.
This might be a source of higher failure rates among their patients. It is important to identify as far as possible high risk categories of patients based on the identified risk factors noted above. Manufacturer, duration of implant, patient symptoms and psychological state have been identified. However these criteria are insufficiently established at present and a patient by patient approach is therefore required. It is important that the risks identified in this opinion are considered in the light of the risks involved in unnecessary explantation.
Question 1A: What is the global reported incident rate associated with PIP breast implants?
Currently available data do not allow a reliable estimate.
Question 1B: How does this compare with the global reported incident rate for other breast implants?
Currently available data do not allow a reliable estimate.
Question 1C: What percentage of this global reported incident rate is associated with rupture of PIP breast implants?
Currently available data do not allow a reliable estimate.
Question 1D: What percentage of this global reported incident rate for PIP implants is associated with other adverse effects on health and what are these adverse health effects?
Currently available data do not allow a reliable estimate.
Question 1E: Is there evidence that PIP breast implants are more difficult to explant, before or after rupture, in comparison with other breast implants?
The evidence although limited indicates that there is no difference provided the device and fibrous capsule is intact. If the device has ruptured and particularly if it has caused substantial inflammation then the removal is more difficult. Thus a higher rupture rate of an implant made by a particular manufacturer would be problematic.
Question 1F: Is there evidence of any increased report of lymph node complications associated with the PIP breast implants?
There is evidence from an animal study of increase in irritancy. In contrast medical grade silicone gel does not cause detectable irritation in animal models. There is limited case history data in PIP explant patients indicating a possible increase in lymph node swelling and painful lymph nodes. It should be noted, however, that there may be overreporting of such conditions. This may arise due to reporting and ascertainment biases as a consequence of the widespread concern generated by media reporting on PIP silicone breast implants when compared to reporting of these conditions in non-PIP implant patients.
Question2
In case reasons for concern related to implanted PIP breast implants are identified, to make a risk/benefit analysis of explantation. The evidence to date, indicating a health risk for women with PIP silicone breast implants, is not strong. However there is some concern regarding an increased inflammation from ruptured PIP silicone breast implants. It is not possible to make a general risk benefit statement at this time. Rather, for the time being, the risk benefit assessment needs to be based on a patient by patient basis by the aesthetic surgeon, bearing in mind the time since the implantation and the psychological state of the patient.
FRENCH PIP IMPLANTS SEQUENTIAL NEWS in 2012
16th March
Around 7000 women in the UK have been fitted with banned PIP breast implants prior to 2001. Therefore all women who have previously had PIP implants should consult with a specialist. The MHRA and the French regulator have now said that PIP implants made before 2001 may also contain the unauthorised non-medical grade silicon.
15th March
The MHRA releases an extension of the device alert relating to PIP implants to include and “pre-2001 PIP implants”(copy here)
7th February
Sir Bruce Keogh, Medical Director of the NHS has told MPs that there is “significant uncertainty” to women with PIP implants. It’s that level of uncertainty which creates the anxiety with relation to the ‘ticking timebomb’.”We are left with uncertainty around the potential damage from the silicone itself.”
6th February
Blood silicone levels are not useful tests to detect implant rupture. There is no correlation between serum silicone levels and the status of the implant.
2nd February
Special Reuters Report on PIP Implants
1st February
The expert report from the European Union has just been published. This is the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) report on “The Safety of PIP Silicone Breast Implants“
30th January 2012
Jean-Claude Mas is reported in the Telegraph newspaper to have told investigators that he used fake business data to fool health inspectors. The industrial gel was in 75 percent of PIP breast implants. This saved the company about one million euros per year.
27th January 2012
Jean-Claude Mas is released on €100,000 bail. He is not allowed to leave France.
26th January 2012
Jean-Claude Mas has finally been arrested today in Marseille. French police will now hold him for up to 48-before deciding on charges, which could include involuntary manslaughter.
22nd January 2012
Numerous protestors have staged demonstrations outside both the Harley Medical Group and the Transform Medical clinics in Birmingham.
20th January 2012
Proposals are being discussed to develop a future model that will protect patients against companies that go into administration leaving them with no recourse if their implants have ruptured except the NHS. Such a scheme would involve the manufacturers having to be registered with an insurance protection scheme, akin to the existing holiday insurance protection, ABTA. The ABTA scheme of financial protection provides a course of redress if something goes wrong and they raisethe standards in the industry and help to ensure that the public get a fair deal. Such a scheme in relation to breast augmentation makes a lot of sense. During the PIP implant scandal we have seen Harley Medical, Transform and Surgicaire refuse to remove and replace the faulty implants, and numerous other small clinics simply close down perhaps to avoid any liability. In addition most specialist breast surgeons favour the reintroduction of a breast implant register (a national register did exist between 1993 and 2006, but it was funded by the Department of Health, not compulsory, and was withdrawn). Such a register would need to be compulsory if it were to enable accurate data collection. These two proposals would be excellent news for patients
19th January 2012
Link to the Yorkshire Evening Post news story:http://www.yorkshireeveningpost.co.uk/news/latest-news/central-leeds/leeds_rush_for_ops_to_swap_pip_breast_implants_1_4155390
17th January 2012
Mr Turton is interviewed by Treatment Advisor: http://www.treatmentadviser.com/before-after-pictures-categories/pip-implants
16th January 2012
Mr Turton has opened a specialist dedicated PIP breast clinic at the Leeds Nuffield Hosptial to deal with demand from patients with the PIP implants. This clinic is exclusively for patients with PIP implants who had breast augmentation performed at other hospitals who require assessment or redo surgery.
15th January 2012
Adverts appeared throughout the National Press, placed by the UK Governement, advising women about faulty French PIP implants. In addition, a large number of angry women protesters marched in protest to the Transform Medical offices on Cavendish Street in London. The Health Minister Andrew Lansley, confirmed that the NHS would support all women who have the implants, but would not be replacing implants that were placed for non-clinical reasons. But if there was agreement with the surgeon, the PIP implants would be removed for free.
14th January 2012
Mr Turton was interviewed live on BBC New 24 to give his reaction to the PIP implant scandal. He explained that women had a right to be angry and that the private clinics that had refused to replace them for free had left patients in an horrendous situation. This combined with different levels of support in different countries was a bitter pill to swallow. He explained his expert findings in the patients he has helped, and how this differed to normal breast implants.
13th January 2012
PIP implants were rebranded as Rofil-Medro or M implants. Some UK women had cheap surgery abroad in Poland, Belgium and Czechoslovakia. They may undergone augmentation with PIP implants by another name and hence be unaware of it.
12th January 2012
ITV reported on the French Silicone Implant story in a documentary at 17:30. They followed several patients who had faulty implants placed by the Harley Medical Group, the company who have continued to refuse to replace them. Chris Choi travelled with one patient Annie Winner, to meet another patient who was undergoing surgery to remove and replace the faulty implants. Kate Ward had the faulty implants placed by Harley Medical in 2005, and she was worried about the unknown health risks of doing nothing. Even though she was symptom free she wanted the implants to be removed and replaced with a known high quality implant. She told ITV that she travelled to see Mr Turton at the Leeds Nuffield to ensure she had expert care in the highest quality and safest environment. Kate had her implants removed without difficulty by Mr Turton; he found both implants to be bleeding silicone. This means no rupture was present and only a small volume of silicone had escaped through the intact implant shell. Kate’s breast showed signs of mild inflammation on the inside and once the bad silicone had been removed she underwent redo- augmentation by Mr Turton using Allergan’s breast implants. Kate was interviewed again just 2-hours after surgery by ITV and she explained her great sense of relief. The ITV team has tracked 100 women caught up in this story. It is an enlightening documentary into the PIP implant scandal.
11th January 2012
Harley Medical went on BBC news to refuse to carry out free implant exchange, placing the blame squarely on the UK regulator. Kate Ward also went on BBC news to tell her story of the PIP implants placed by Harley Medical Group 5 years ago. She was refused exchange surgery by Harley Medical and came to Mr Turton at the Leeds Nuffield for exchange of PIP implants to the FDA approved Allergan implants. Just 24-hours after surgery she was live on the main BBC evening news discussing the findings. Mr Turton was also interviewed live and he explained how she had marked silicone bleed- a leakage of the the industrial silicone through the implant’s supposed protective shell. Kate’s breast tissue was otherwise intact and Mr Turton was able to rectify her problem in what was a straightforward operation. Mr Turton reiterated that he felt the private clinics who placed these French PIP implants in the first place had a moral duty to provide the after care and support. He felt that should offer free implant exchange where requested and desired by the Specialist. The Dutch Government becomes the latest to support free exchange of implants for the PIP victims.
10th January 2012
The Welsh Government has announced today that it will offer free of charge redo breast augmentation to all women who received the banned PIP implants, including those who were treated privately. This will be available on the NHS in Wales. It will only apply to women who can prove they have exhausted all options of recovering such surgery from the original private provider. It will also only be available to Welsh women who have a GP within a Welsh post-code. Approximately 2000 women in Wales are thought to have been augmented with the French PIP implants.
8 January 2012
Harley Medical have reported that they were responsible for placing the faulty French PIP implants into 13,900 women up until as recently as March 2010.
6th January 2012
From 2005 the manufacturing of the PIP implant changed. The outer shell was altered by the manufacturer removing a layer and this may have caused an increase in the fragility of the implants.
Breaking News:
Today the UK Government has reiterated that it has found no evidence to recommend the routine removal of all PIP implants. If the PIP implants have been placed by the NHS as part of reconstructive breast surgery, the implants can be replaced on the NHS after consultation with your specialist. However, the UK Government is not offering this to patients who had private cosmetic breast surgery with PIP implants. The expert review also stated that they can not be confident that PIP did not change the silicone in the implants, so they cannot rule out the possibility that some are toxic.
The NHS will support removal of PIP implants if originally inserted by the NHS, and that it is justified by an assessment of clinical need, risk or the impact of unresolved concerns, and that the woman with her doctor decides that it is right to do so. The Department of Health has issued a statement that it expected private firms to follow the NHS offer on removal and replacement of the implants among those women with anxieties and that they believe private providers have a duty to take steps to provide appropriate after-care to patients they have treated. The private providers have legal obligations to their patients. The NHS will offer a package of care for its patients, and the Department of Health expect the private sector to do the same.
URGENT UPDATE ON PIP IMPLANTS: STATEMENT BY ANDREW LANSLEY, SECRETARY OF STATE
The following statement has been released on Friday 6th January 2012
The interim report of the expert group brought together in relation to breast implants made by PIP has been released today.
A statement has been released from the Department of Health and Andrew Lansley
Mr Dick Rainsbury, President of the Association of Breast Surgery has made the following statement:
‘Today’s announcement on the management of patients with PIP breast implants is to be welcomed. As the ABS representative on the Expert Advisory Group to the MHRA and the DoH, I strongly supported the indications for implant removal based on a lack of evidence of safety, alongside BAPRAS and BAAPS. These indications include symptomatic/asymptomatic rupture, or sufficient patient concern about the substandard nature of these devices, in the absence of evidence of rupture (‘preventative’ removal).
Around 95% of these implants (involving circa 40K women) have been used for augmentation, with an estimated 3K used during reconstruction. Where patients elect implant removal, the NHS will fund removal/exchange following previous reconstruction in the NHS. Private Providers will be expected to play their part in explantation/exchange, but for women unable to access this service, the NHS will undertake to carry out explantation only.
Clearly, this decision has the potential for a major impact on our referrals and workload. I have made very clear representations to the group about the potential for derailing CWTs, recommending that patients are referred outwith the 2WW.
Supported by BAPRAS and BAAPS, we are recommending the following ‘routes of referral:
1. Patients with new breast symptoms and/or clinical signs are referred to NHS breast surgeons
2. Asymptomatic patients are referred back to the private provider
3. Asymptomatic patients unable to access the private provider are referred to NHS plastic surgeons
The Expert Group will now carry out a fundamental review of the systems in place for the reporting and regulation of implant surgery, and we will continue to represent the interests of our patients and our members’.
A press release has also been issued by the Royal College of Surgeons of England, along with the ABS, BAAPS and BAPRAS
This section below is the Sir Bruce Keogh Report (NHS Medical Director) 6th January 2012
It is the report of the expert group convened under the chairmanship of Sir Bruce Keogh to review policy in relation to French PIP breast implants
Introduction
This is the interim report of the expert group convened under my chairmanship to review policy in relation to breast implants from the French company Poly Implant Prostheses (PIP). The members of the group are listed at Annex A.
The overriding concern of the group is the safety and compassionate treatment of women with PIP breast implants. In our report we:
- review the available data on the health risks from PIP implants
- conclude that there is no clear evidence at present that patients with a PIP implant are at greater risk of harm than those with other implants, and we therefore agree with the MHRA advice that there is no specific safety concern identified which requires a recommendation of routine removal of PIP implants
- recognise the anxiety of many women who received PIP implants in good faith on the assumption that they were manufactured in accordance with EC standards
- commend and endorse the decision of DH ministers that, where women have received a PIP implant as part of NHS treatment, they will be contacted to inform them that they have a PIP implant and to provide relevant information and advice; and will be offered further procedures subject to clinical need and taking full account of the wishes and concerns of the patient
- expect private sector providers to take similar action
- the available evidence is subject to considerable uncertainty and therefore we recommend the collection of additional information which will enable the group reach a more informed view.
A summary of our provisional conclusions and recommendations for further work is at Annex B.
3. The group will reconvene in about 4 weeks’ time to review any new evidence and to consider whether this advice needs to be amended.
Background
4. Breast implants are regulated under a European Union Medical Device Directive . See Annex C for further details.
5. PIP received a CE mark for their silicone gel breast implants in 2000 via the German Notified Body TUV Rheinland and started exports to the UK in that year. Between 2001 and 2009 about 80,000 implants (representing some 40,000 women) were sold in the UK and, to date, some 478 adverse incident reports have been received. This rate of incidents was not considered to be significantly different from that for other brands of implant.
6. From about 2006 onwards, concerns began to emerge among cosmetic surgeons about the performance of PIP implants . In 2008 the MRHA noted an increase in the number of reports of ruptures and raised concerns with the manufacturer and the notified body, but this was understood to be the result of an increase in sales and improvements in the manufacturer’s reporting criteria. The MHRA raised further concerns in 2009. In March 2010 the French regulator Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), discovered that the manufacturer had been using industrial grade silicone instead of the medical grade specified for the CE mark. AFSSAPS revoked the CE mark and the MHRA promptly issued a medical device alert to all UK clinicians and cosmetic surgery providers, asking them to cease using the implants.
7. Toxicology tests on samples of filler material in both France and the UK suggested that there was no significant health risk to women who had already received the implants.
8. On 20 December 2011, following a large increase in the number of reported ruptures and concerns over a possible cancer risk, AFSSAPS wrote to European competent authorities (ie regulatory bodies) alerting them to the new data. On 23 December the French Ministry for Health announced that it was advising women, as a precautionary measure, to consider explantation . After consideration of the evidence reported within the UK and consultation with other countries known to have used PIP implants, the MHRA issued interim advice. This suggested that, on the available data, women in the UK should not be advised to seek explantation in the absence of clinical symptoms .
9. Our immediate task was to review the available data, including further information from the French authorities and to consider whether there is a need to revise the current advice in the UK.
Issues considered by the group: (i) Safety Issues
10. The first set of issues considered by the group was whether, on the balance of evidence, women with PIP implants who have no current symptoms should be advised as a precautionary measure to seek an explantation, or should be advised (as at present) to wait for the possible development of symptoms that might indicate a rupture. This involves balancing the risks associated with PIP implants, including the risks resulting from possible rupture of the implant, against the risks of undertaking explantation surgery earlier than might otherwise be necessary.
The cancer risk
11. The expert group consider that, on the available data, there is no evidence that PIP implants are associated with a higher risk of breast cancer than other silicone gel implants. This is in line with the advice of the French National Institute for Cancer (INCA) that “the number of breast cancers seen in women with PIP implants is less than the levels for the general population”.
12. In February 2011 MHRA issued a safety alert on the possible, but very low risk, link to anaplastic large cell lymphoma of silicone gel implants in general. No cases have been recorded in the UK.
The significance of the use of industrial grade silicone rather than medical grade silicone in implants
13. The composition of silicone used by PIP during the period of manufacture is not certain. However, it is clear that the material used cannot be guaranteed to have been submitted to the same rigorous toxicological testing as is required to meet the essential requirements of the Directive. We can draw no conclusions from this about its quality in the context of breast implants.
Signs and symptoms of rupture
14. Guidance on signs and symptoms of rupture has been prepared as part of our guidance to clinicians – see paragraph 29 below.
Health consequences of a rupture
15. Breast implant ruptures, or leaks of gel, may result in inflammation of the surrounding tissues. The tissue responses may be reflected by lumpiness, swelling and discomfort in the local or regional tissues. Other signs of rupture include changes in the shape, consistency and symmetry of the breast. According to the AFSSAPS data as at 28 December , some 495 women with PIP implants have suffered an inflammatory reaction, or about 1.7% of the estimated 30,000 women in France with such implants. We are not aware of any available estimates for other implants against which we could compare this figure.
16. Since the 1970 breast implants have evolved through a number of evolutionary stages/ generations. Contemporary implants contain a cohesive gel in which the polymer is cross linked and the gel “form stable”. This cohesive characteristic of the gel reduces the risks associated with rupture as the gel is “held together” and is less likely to migrate into the breast tissues or the lymphatic system. It appears that the gel within PIP implant is significantly less cohesive than other contemporary implants. The implications of this include a greater tendency to interface with the local tissue and a greater potential to generate an inflammatory response. There is also some data supporting an increased risk of in vivo transdermal irritation from PIP implants. Members of the UK professional bodies for cosmetic surgery for cosmetic surgery report anecdotal evidence that, when a PIP implant ruptures, silicone gel is more widely dispersed in surrounding tissue and the resulting explantation is more difficult and more involved. This could result in a more prolonged hospital stay with additional risks. Two case studies have been published although it appears in these two cases that there were no long-term effects on health.
17. Laboratory tests on samples from PIP implants, both in the UK and in France, have shown no significant evidence of mutagenicity (potential to cause cancerous mutations). One test reported from France found that gel from PIP implants was more likely to cause an inflammatory reaction in rodents than standard, medical grade, silicone gel.
The risk of ruptures
18. Much attention so far has been given to the issue of rupture in breast implants. The cumulative risk of rupture of a breast implant increases progressively over time. An analysis published by the FDA showed that the rupture rate for the Allergan implant is 0.5% after 2 years, rising to 10.1% (cumulative) after 10 years. For Mentor implants, the post implantation failure rate at 8 years was 13.6% (cumulative). It follows that quoting a “rate of rupture” for an implant, without specifying the time since the original implant, is unhelpful and potentially misleading.
19. There is no data on PIP implants of comparable quality to the FDA study mentioned above. We invited the sector to send us recent comparative data on PIP and other silicone breast implants (Annex D) and have concluded we can place no reliance upon these figures, which for non PIP implants are inconsistent with the FDA study by a fivefold factor. More work clearly needs to be undertaken by the sector to ensure that more reliable data can be produced in future.
20. There are a number of other difficulties in comparing risks of rupture for PIP and other implants:
i. much of the available information is subject to potential under-reporting. Although the manufacturers are required to report all serious adverse events (including rupture), notifications from providers in the UK to the regulator are voluntary. Cosmetic surgery providers will only be aware of problems if patients come back to them for follow-up, and many patients may seek advice elsewhere (including the NHS). We believe that under-reporting seriously affects the validity of current PIP data and some comparative data about similar implants;
ii. it is not clear whether all PIP implants have been affected by the use of substandard silicone to the same extent. For instance, it has been suggested that PIP continued to use medical-grade silicone in the implants supplied to Australia, so the apparently reassuring data from the Australian regulator may not be a valid guide to risks in the UK;
iii. some ruptures – perhaps as many as 2 in 3 – do not result in clinical signs or symptoms, and can only be detected by scanning or by explantation (removal). Ruptures reported after explantation, such as the recent data on PIP implants from the French regulators, cannot therefore be compared directly with data from routine reporting on other implants.
21. On the currently available information, the group considers that the statistical evidence on the rate of ruptures for PIP implants compared with other implants is incomplete and this risk cannot be assessed accurately. For this reason it is unable to come to any view on comparative rupture rates. We attach the data received at Annex D.
Risks associated with explantation
22. As noted above, a full assessment of the safety aspects of PIP implants involves balancing the risks associated with leaving the implants in place against the risks of undertaking explantation surgery earlier than might otherwise be necessary. In this context, it is worth bearing in mind that all breast implants have a finite life – data from the FDA suggest that 1 in 5 cosmetic breast implants, and 1 in 2 breast implants following reconstruction surgery, are explanted or replaced within 10 years.
23. Women who receive breast implants are, in general, a very healthy sector of the population. Advice from the Royal College of Anaesthetists is that the risk of anaesthetic mortality in healthy adults is of the order of 1 in 100,000 to 1 in 250,000 . If all 40,000 women in the UK with PIP implants had explantation surgery, the estimated excess deaths would therefore be about 0.4 or less. The available literature confirms the view of members of the expert group that there are no significant risks of morbidity associated with explantation per se over and above the risk of the original operation.
Issues considered by the group: (ii) practical clinical issues
24. Whatever the objective evidence on safety, many women with PIP implants will understandably be very worried about the possible implications for their health. In itself, this anxiety is a form of health risk and must be addressed with understanding and compassion by those responsible for their treatment.
25. Women who received PIP implants will have been informed about the risks associated with breast implants in general, in line with current best practice guidance . They will however have assumed, in good faith, that the material to be used in the implants was medical grade silicone, in line with the CE mark. Now that we know that a substantial proportion of PIP implants have used industrial grade silicone, we believe that there is a duty of care on the part of the providers of surgery to offer these women whatever is reasonably needed to reassure them that they will not suffer long-term health effects as a result of the deception by PIP.
26. A minority of women with PIP implants have received these implants as a result of reconstruction surgery carried out by the NHS, eg following surgery for breast cancer. Ministers have already made clear that:
• All women who have received a PIP implant from the NHS will be contacted to inform them that they have a PIP implant and to provide relevant information and advice. If in the meantime NHS patients seek information about the make of their implant then this will be provided free of charge;
• Women who wish to will able to seek a consultation with their GP, or with the surgical team who carried out the original implant, to seek clinical advice on the best way forward;
• If the woman chooses, this could include a non-urgent examination by imaging to see if there is any evidence that the implant has ruptured;
• The NHS will support removal of PIP implants if, informed by an assessment of clinical need, risk and the impact of unresolved concerns, a woman with her doctor decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS.
27. The group endorses this offer. It expects providers in the private sector to take similar steps (as one major provider, the Nuffield Hospital Group, has already signalled) .
28. Clinicians, in advising women, should make clear that (on current evidence) explantation would be a precautionary measure rather than because of a definite risk to health.
29. Guidance to GPs and surgeons, on the clinical indications that an urgent referral might be needed in relation to concerns about any implant of this type, is attached at Annex E.
30. Where patients find that their private sector provider is no longer in practice, the group considers that in the event of their approaching the NHS and where the clinical need has been identified, only non-urgent removal – rather than removal and replacement – should be offered.
Issues considered by the group: (iii) equalities implications
31. We have considered whether the public sector equality duty in s149 of the Equality Act 2010 is relevant to our deliberations, and whether anyone sharing a ‘protected characteristic’ listed under that legislation will be subject to special disadvantage. Protected characteristics include age, disability, gender, gender reassignment status, marriage and civil partnership status, pregnancy and maternity status, race, religion or belief, and sexual orientations.
32. We have concluded that there is no evidence to support a conclusion that anyone sharing a protected characteristic as described above is subject to special disadvantage.
Further work
33. Further information is needed in particular on the risks associated with the rupture of PIP implants and the resulting inflammatory reaction. The group will be reconvened to review these issues and to consider whether any change is needed to our advice.
34. As a second stage, the Secretary of State has asked me to prepare a report on the lessons learned from this issue including:
i current arrangements for the monitoring of the safety of breast implants and other implantable devices, including the proposal from professional organisations to re-establish the breast implant registry which the department discontinued in 2007;
ii the regulation and governance of the cosmetic surgery industry.
35. I propose that this further review should be undertaken by a reconstituted review group, including the organisations represented in this expert group with additional membership from the independent healthcare industry, the CQC and the NPSA.
Sir Bruce Keogh
NHS Medical Director
January 6 2012
Provisional Conclusions and Recommendations for Further Work
The expert group:
• Considers, on the available data, that there is no evidence that PIP implants are associated with a higher risk of breast cancer than other silicone gel implants.
• Finds it clear that the composition of silicone used by PIP during the period of manufacture cannot be guaranteed to have been submitted to the same, rigorous toxicological testing as is required to meet the essential requirements of the Directive. We can draw no conclusions from this about its quality in the context of breast implants.
• Agrees that more work clearly needs to be undertaken by the sector to ensure that more reliable data on silicon breast implants can be produced in future.
• Considers that the statistical evidence on the rate of ruptures for PIP implants compared with other implants is incomplete and this risk cannot be assessed accurately. For this reason it is unable to come to any view on comparative rupture rates.
• Believes that there is a duty of care on the part of the providers of surgery to offer these women whatever is reasonably needed to reassure them that they will not suffer long-term health effects as a result of the deception by PIP.
• Endorses the offer made by Ministers to women with PIP implants who have received these implants as a result of reconstruction surgery carried out by the NHS, eg following surgery for breast cancer.
• Expects providers in the private sector to take similar steps.
• Considers that in the event of private sector patients approaching the NHS and where the clinical need has been identified, only non-urgent removal, rather than removal and replacement should be offered.
• Has concluded that there is no evidence to support a conclusion that anyone sharing a protected characteristic as described in the Equalities Act 2010 is subject to special disadvantage.
• The group will be reconvened after further information is received to review the risks associated with the rupture of PIP implants and the resulting inflammatory reaction and to consider whether any change is needed to our advice.
In addition, a further review will be undertaken by a reconstituted review group, including the organisations represented in this expert group with additional membership from the independent healthcare industry, the CQC and the NPSA, to consider:
• current arrangements for the monitoring of the safety of breast implants and other implantable devices, including the proposal from professional organisations to re-establish the breast implant registry which the department discontinued in 2007; and
• the regulation and governance of the cosmetic surgery industry.
CLINICAL GUIDANCE FOR GPs AND SURGEONS
Patients: Any patient with breast implants is advised to check the details of their implant with their surgeon or clinic.
GPs consulted by patients with PIP implants should explore the patient symptoms and examine the breast and locoregional lymph nodes.
Patients with local signs and symptoms should be referred for a specialist opinion.
Signs will include
• Lumpiness of the breast
• Lumpiness/ swelling of the regional lymph nodes
• Change in shape of the breast
• Deflation of the breast
• Redness
• Tenderness of the breast
• Swelling of the breast
Symptoms may include
• Pain
• Hyperaesthesia
Guidance for GPs for NHS specialist referrals
Patients with PIP implants who experience lumpiness within the breast and lymph nodes : In cases where there is concern regarding the nature of the lumpiness, referral should be made to a rapid access breast service. In cases where the practitioner is happy that the lumps are associated with the implant or gel, referral should be made to the regional reconstructive breast surgery department
Patients with changes in shape or feel of the breast, for instance discomfort, deflation or asymmetry should be referred to their regional breast reconstructive unit. These patients do not require fast track referral.
Surgeons: Surgeons and hospital specialists reviewing patients with PIP implants should carefully assess the patient for the possibility of rupture or leak. Those patients who have evidence of implant rupture should be advised regarding the implications of implant removal/ exchange. If it is felt that the risk benefit ratio favours explantation/ exchange then this procedure should be advised. For NHS patients the patient may be offered re-implantation. For patients from the private sector who have been unable to secure help from their original provider, the NHS will offer implant removal where it is felt to be clinically appropriate, but no re-implantation will be offered.
This guidance may change after consultation with relevant parties.
Guidance for GP referrals for private patients
General Practitioners may be approached by patients who underwent their surgery in the private sector. These patients should be advised to contact their original provider. It is expected by the expert group and the professional bodies represented on it that these providers will offer the same service as the NHS without cost to the patient.
Ongoing review
Where a patient decides, after consultation with her GP or specialist, not to have an explantation, she should be followed up on an annual basis. This review would normally be carried out by the GP (for NHS patients) or by the clinic which carried out the original implant (for private patients).
ANNEX C: REGULATION OF MEDICAL DEVICES
There are over 90,000 types of medical device on the market in the UK. These are regulated under the provisions of the European Medical Devices Directives.
Medical device regulation differs substantially from the regulation of medicines. The safety of medical devices is assessed by independent third party organisations. The licensing of medicines is undertaken by state regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA).
All medical devices such as breast implants require a CE mark of conformity
before they can be marketed in Europe. For all but the lowest risk devices the CE mark must be authorised through assessment by an independent third-party organisation, known as a notified body. There are over 80 of these notified bodies across Europe.
Each notified body is appointed and audited by the Competent Authority (regulatory authority) in their respective country. A manufacturer can select any notified body across Europe irrespective of location, provided that their field of expertise covers the device being considered. Once a CE mark is applied the medical device can be sold in all EU countries without further controls.
The regulations are implemented by a Competent Authority in each member state. In the UK this is the MHRA. The role of the Competent Authority is to implement the provisions of the directives, to appoint and control notified bodies and to monitor and investigate adverse events occurring in their country. In the UK this involves investigating both mandatory serious adverse event reports from manufacturers and adverse events reported voluntarily by healthcare professionals and members of the public. As a result of these investigations MHRA will take further action as appropriate including recalling faulty products (safeguard action) and offering advice to the health service through Medical Device Alerts.
ANNEX D: PIP IMPLANT DATA SUPPLIED BY UK COSMETIC SURGERY PROVIDERS TO MHRA BY 5PM ON 5 JANUARY 2012
For cautions on the interpretation of the data, see paragraphs 18 – 21 in the report.
The following tables set out the data returned by providers to the MHRA before 5pm GST on 5 January 2012. Further data received will be taken into account
BMI Healthcare
Date of first implantation 2002
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 230 1
2nd year 192 1
3rd year 166 0
4th year 381 0
5th year 141 0
6th year 88 1
7th year 44 1
8th year 58 6
9th year 11 4
10th year 0 0
County Durham and Darlington NHS Foundation Trust
Date of first implantation
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year 72
2nd year 94
3rd year 121
4th year 118
5th year 110
6th year 35
7th year 0
8th year 0
9th year 0
10th year 2011 0
Harley Medical Group
Date of first implantation Jan-00
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 11837 4
2nd year 11160 28
3rd year 8838 72
4th year 6010 79
5th year 3875 60
6th year 2024 53
7th year
8th year
9th year
10th year
IHAS – Court House Clinics
Date of first implantation 20/01/2004
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 3
2nd year 12 1
3rd year 20
4th year 20
5th year 27 1
6th year 22
7th year 37
8th year
9th year
10th year
IHAS – Make Yourself Amazing
Date of first implantation 29/07/2007
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 0 0
2nd year 0 0
3rd year 1 0
4th year 3 0
5th year 44 4
6th year 0 0
7th year 0 0
8th year 0 0
9th year 0 0
10th year 0 0
IHAS- Aspen
Date of first implantation 2000
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 36 0
2nd year 40 0
3rd year 43 0
4th year 11 0
5th year 4 0
6th year 3 0
7th year 1 0
8th year 3 0
9th year 2 0
10th year 0 0
IHAS – Bridgewater Hospital
Date of first implantation 17.05.2007
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 6
2nd year 2
3rd year
4th year
5th year
6th year
7th year
8th year
9th year
10th year
Linia Cosmetic Surgery
Date of first implantation 2.04.2003
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 0 0
2nd year 0 0
3rd year 21 3
4th year 147 6
5th year 148 1
6th year 150 8
7th year 104 1
8th year 277 2
9th year 0 0
10th year 0 0
Mid-Cheshire Hospitals NHS Foundation Trust
Date of first implantation
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year
3rd year 1
4th year
5th year
6th year
7th year
8th year
9th year
10th year
Mid-Essex Hospital Services NHS Trust
Date of first implantation
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year 0
2nd year 0
3rd year 0
4th year 0
5th year 0
6th year 0
7th year 0
8th year 0
9th year 0
10th year 0
11th year 0 1
New Victoria Hospital
Date of first implantation 1998
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 5 0
2nd year 5 0
3rd year 7 0
4th year 14 0
5th year 22 0
6th year 2 0
7th year 0 0
8th year 0 0
9th year 0 0
10th year 1 0
NHS Herefordshire West Mercia
Date of first implantation
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year
3rd year 1
4th year
5th year
6th year
7th year
8th year
9th year
10th year
North Tees and Hartlepool NHS Foundation Trust
Date of first implantation 2000
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year 2 1
2nd year
3rd year
4th year
5th year 1
6th year
7th year 11
8th year
9th year
10th year
11th year 3
12th year 2
Royal Cornwall Hospitals Trust
Date of first implantation
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year
3rd year 1
4th year 1
5th year 1
6th year
7th year
8th year
9th year
10th year
Spire Healthcare
Date of first implantation 1999
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 1 0
2nd year 18 1
3rd year 108 1
4th year 113 1
5th year 158 2
6th year 278 10
7th year 308 15
8th year 273 4
9th year 131 4
10th year 32 1
The Christie NHS Foundation Trust
Date of first implantation N/A
Post-operative year Number of Implants How many women have had explants due to rupture during this post implant year?
1st year 0 0
2nd year 0 0
3rd year 0 0
4th year 0 0
5th year 0 0
6th year 0 0
7th year 0 0
8th year 0 0
9th year 0 Not Determined
10th year 0 Not Determined
Transform
Date of first implantation 2004
Year of post-operative experience Number of women with this post operative experience How many women have had explants due to rupture during this post implant year?
1st year 2939 2
2nd year 1232 1
3rd year 52 6
4th year 21 17
5th year 27 17
6th year 5 42
7th year 5 45
8th year 17
9th year 0
10th year 0 0
University Hospitals Coventry and Warwickshire
Date of first implantation Never
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year
3rd year
4th year
5th year
6th year
7th year 1
8th year
9th year
10th year
University Hospital of South Manchester
Date of first implantation 2000
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year 1 0
2nd year 0
3rd year 0
4th year 0
5th year 0
6th year 0
7th year 0
8th year 0
9th year 1 0
10th year 2 0
The Trust does not use PIP implants. The Trust operated on patients with PIP implants for removal.
University College London Hospitals NHS Foundation Trust
Date of first implantation 1998
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1998 2
1999
2000 1
2001
2002 2
2003
2004
2005
2006
2007
University Hospitals of Morecambe Bay NHS Foundation Trust
Date of first implantation N/A
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year 1
3rd year
4th year
5th year
6th year
7th year
8th year
9th year
10th year
Warrington Hospitals NHS Foundation Trust
Date of first implantation 2006
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year
3rd year 1 1
4th year
5th year 1 1
6th year
7th year
8th year
9th year
10th year
Yeovil District Hospital
Date of first implantation Jan-07
Post-operative year Number of women How many women have had explants due to rupture during this post implant year?
1st year
2nd year
3rd year
4th year 1 1
5th year
6th year
7th year
8th year
9th year
10th year
ANNEX E: CLINICAL GUIDANCE FOR GPs AND SURGEONS
Patients: Any patient with breast implants is advised to check the details of their implant with their surgeon or clinic.
GPs consulted by patients with PIP implants should explore the patient symptoms and examine the breast and locoregional lymph nodes.
Patients with local signs and symptoms should be referred for a specialist opinion.
Signs will include
• Lumpiness of the breast
• Lumpiness/ swelling of the regional lymph nodes
• Change in shape of the breast
• Deflation of the breast
• Redness
• Tenderness of the breast
• Swelling of the breast
Symptoms may include
• Pain
• Hyperaesthesia
Guidance for GPs for NHS specialist referrals
Patients with PIP implants who experience lumpiness within the breast and lymph nodes : In cases where there is concern regarding the nature of the lumpiness, referral should be made to a rapid access breast service. In cases where the practitioner is happy that the lumps are associated with the implant or gel, referral should be made to the regional reconstructive breast surgery department
Patients with changes in shape or feel of the breast, for instance discomfort, deflation or asymmetry should be referred to their regional breast reconstructive unit. These patients do not require fast track referral.
Surgeons: Surgeons and hospital specialists reviewing patients with PIP implants should carefully assess the patient for the possibility of rupture or leak. Those patients who have evidence of implant rupture should be advised regarding the implications of implant removal/ exchange. If it is felt that the risk benefit ratio favours explantation/ exchange then this procedure should be advised. For NHS patients the patient may be offered re-implantation. For patients from the private sector who have been unable to secure help from their original provider, the NHS will offer implant removal where it is felt to be clinically appropriate, but no re-implantation will be offered.
This guidance may change after consultation with relevant parties.
Guidance for GP referrals for private patients
General Practitioners may be approached by patients who underwent their surgery in the private sector. These patients should be advised to contact their original provider. It is expected by the expert group and the professional bodies represented on it that these providers will offer the same service as the NHS without cost to the patient.
Ongoing review
Where a patient decides, after consultation with her GP or specialist, not to have an explantation, she should be followed up on an annual basis. This review would normally be carried out by the GP (for NHS patients) or by the clinic which carried out the original implant (for private patients).
Older News on French PIP Implants:
1. PIP were accused by their insurers in 2006 of concealing complaints from regulators.
2. A report in 2005 by Dr Grant Stevens, consultant plastic surgeon in Los Angeles demonstrated that PIP implants were three-and-a-half times more likely to rupture than a test group. He compared rupture rates between 500 PIP saline implants and 500 saline implants manufactured by Mentor. This is a reflection of the integrity of the shell of the PIP implants. Within four years it was noted that 15% of the PIP implants had ruptured compared to just 4% of those made by Mentor.
3. Dr Grant Stevens claims that PIP asked him not to report his study.
4. PIP’s insurers apparently wrote to PIP in 2006 accusing them of deliberately hiding complaints about the implants from surgeons and clinics. “They failed to notify them or French regulators of incidents which would necessitate the implants removal” reported Sky News. They found evidence of over 4000 claims. “We hold that PIP by a deliberate, wilful and financially-rewarding violation of the regulations, prevented the authorities conducting an enquiry to try and stop the incidents.”
5. In March 2000, USA regulators found eleven deviations from “good manufacturing practices” at the PIP factory in France.
6. In February 2009, the UK regulatory authority was warned of a number of medical claims against the company.