Information Sheet for Patients Undergoing Breast Augmentation

The Breast Augmentation Information Sheet can be downloaded here: Breast Augmentation information sheet (for patients) 2019

Introduction on Breast Augmentation: Breast Enlargement Surgery UK

The terminology of breast enlargement is important to understand. It is colloquially referred to as a boob job, but we prefer the term breast enlargement and this is the term my patients use with me. When we write about breast enlargement on medical letters or in journals we use the term breast augmentation or augmentation mammoplasty.

We essentially enlarge the breasts to try to improve femininity. The breast has been the symbol of femininity since the earliest time. Often, to a woman, in her perception of her body and her concept of self, the size and shape of her breasts plays a dominant role. Whilst padded bras do give the illusion of increased breast size and they help superficially they can paradoxically cause increased problems for a woman once they are removed and the breasts assume their natural appearance. Breast augmentation has been performed for centuries but the techniques 100-years ago were pretty hopeless involving the transplant of a fatty growth, or the use of experimental materials that were not successful. All of this changed in the early 1960’s and for the last 55-years breast augmentation has become an established surgical technique that is proven to improve a woman’s body image and her perception of self with usually positive psychological effects.

Who chooses to have Breast Enlargement?

There are 2 main groups of women who request this operation. The commonest group of women are represented by mothers of children who were happy with firmer larger breasts before or during pregnancy, or who have found that subsequent to pregnancy and childbirth the breasts have decreased in size and seemingly deflated. This is often with emptiness in the upper half, causing a more scalloped appearance and sometimes combined with loose skin. The lower pole of the breast may overhang the crease under the breast. The second group is represented by young or middle-aged women who are yet to start a family or have decided not to have children, who wish to have breast enlargement as they consider their breasts to be of insufficient size, often disproportionately small to their frame.

How do I go about finding more information on Breast Enlargement?

Unfortunately, unless there is a significant underlying medical condition which has to lead to a deformity of the breast or a postoperative deformity that requires correction it is not possible to obtain augmentation mammaplasty on the NHS except in exceptional circumstances. There are numerous sources of information on augmentation from books, magazines, to articles posted on the internet, and these should be complemented by a good quality in depth consultation with the specialist surgeon who will perform the augmentation. Please use our consultation contact form to get in touch.
Mr Turton is happy for women to book to see him directly, but it is considered good medical practice for the surgeon to keep the patient’s general practitioner informed of any consultations and medical interventions that subsequently occur. He will write to your GP after each consultation unless you explicitly inform him that you do not wish this. Please provide this in writing at the consultation too. Mr Turton has produced this information to supplement your reading and provide a basis to enhance your understanding and for informed consent. Additional information from Allergan, one of the leading suppliers of implants maybe found here.

How do I select a surgeon for Breast Enlargement?

Not all surgeons will have the necessary skill, patient numbers, years of experience, or technical ability and artistry. Breast augmentation should only be performed by a Specialist Surgeon trained and experienced in the technique, such as Mr Turton. If your surgeon is expert they are also likely to have excellent feedback and few complaints. Check the “I Want Great Care” Web Site, which is independent, and see what is said about your surgeon. Read every single review you can find and research thoroughly. Be prepared to travel to find the right person.

Your surgeon must be on the GMC specialist register as a surgeon in a specialty that does this type of surgery. Your surgeon’s credentials for performing Cosmetic Breast Surgery can be verified on the Royal College of Surgeons web site which records all Specialist Surgeons who have Full Certification to carry out such procedures in the UK- check the credentials here. You will find that for Cosmetic Breast Surgery the background of your surgeon’s training should have origins in the specialty of plastic surgery with special interest in breast surgery, or be a Specialist Breast Surgeon who comes from a general surgery parent specialty. Mr Turton is a Specialist Breast Surgeon and his clinical workload relates entirely to breast surgery, reconstructions of the breast, surgery for women with breast disorders and all aspects of cosmetic breast surgery including complex cosmetic work.

Your Specialist Breast Surgeon should be a member of the Association of Breast Surgery, (ABS) and in addition to this the Department of Health now recommends that they are Fully Certified to perform Cosmetic Breast Surgery by the Royal College of Surgeons. The Specialist Information website lists more details about the surgeon’s ‘usual’ practice, and this is a very helpful site to check more about your consultant. They do charge you just £2.99 for access, but this is money well spent if you are not sure about your surgeon’s usual area of practice. The link to the Specialist Information web site is here. Further details might be found from reviewing their NHS practice too, for example regarding Mr Turton who is listed on the St James’s Teaching Hospital web site as being a Specialist in Breast Surgery- see link here.

The National Care Standards Commission is a new agency set-up by the government to ensure the regulation of cosmetic surgery in private hospitals and if you approach a surgeon offering augmentation mammoplasty in the private hospitals within Yorkshire they will have had to fulfill the requirements to be allowed to provide this surgery. It is obviously our opinion that any surgical intervention is better carried out by local experts rather than travelling far and wide. Mr Turton is a Specialist Breast Surgeon and performs Cosmetic Breast Surgery including breast augmentation (also referred to as breast enlargement or simply ‘boob job’), breast reductions, breast uplift (also referred to as breast mastopexy), correction of nipple inversion, tuberous breast deformity, breast asymmetry surgery, breast reconstruction, and breast liposuction. He is trained from the parent specialty of General Surgery (includes breast, oncoplastic and reconstructive breast, vascular, upper and lower GI, endocrine) and within this specialty trained further in breast, reconstructive breast, oncoplastic breast and cosmetic breast surgery. This specialist training reinforced his special area of interest in Cosmetic Breast Surgery which he has performed expertly at Consultant level since 2004. His practice is appraised annually, he is a full member of the Association of Breast Surgery and he is Fully Certified by the Royal College of Surgeons in the field of  Cosmetic Breast Surgery.

Mr Turton is Director of the Leeds Breast & Cosmetic Clinic and treats private patients at the Leeds Nuffield Hospital and Spire Hospital Leeds. He has been carrying out all aspects of Cosmetic Breast Surgery since 2004 and has performed many thousands of breast operations.

Mr Turton was also one of the first UK specialists to be awarded Full Certification status in Cosmetic Breast Surgery by the Royal College of Surgeons. He is a Full member of the Association of Breast Surgery (ABS) and is a past member of the ABS Clinical Practice and Standards Committee. Mr Turton is also an active member of the Aesthetic sub-committee of the ABS who meet three times per year at the Royal College of Surgeons. This Aesthetic Committee serves the interests of the ABS members who have a special interest in Aesthetic Breast Surgery in the UK. In addition, Mr Turton’s NHS Consultant work is exclusively as a Specialist Breast Reconstructive and Oncoplastic Breast Surgeon. Even within his NHS work he routinely carries out aesthetic breast surgery with breast augmentation, breast reduction and mastopexy where required for congenital and developmental problems or in relation to reconstruction to obtain symmetry with the other breast. Mr Turton has been in continuous full-time employment as a Consultant Specialist Breast Surgeon at Leeds Teaching Hospitals Trust since 2004.

Pre-operative evaluation for Breast Augmentation

You will be seen by your consultant and various questions asked concerning your approach to breast augmentation. You will be asked why you wish your breasts to be enlarged, what size you would like them to be and if you had been pregnant previously the breast size that was attained.

The most common answer to the first question is that women wish to look better in their clothes and be in better proportion to the rest of their body, or be returned to the size they were prior to pregnancy. As far as the second question is concerned it is unrealistic to give an exact estimation of cup size following the procedure but a general opinion can be given. It is important to achieve a balance between what the woman wants and what is possible surgically given the limitations of the woman’s chest size and tissues etc. Finally, if the woman did not enjoy having larger breasts during pregnancy it is unlikely that a breast augmentation will be a positive experience.

Your medical and any previous surgical history will be taken and any medications that you currently use will be documented. Pre-existing illnesses, especially of any skin diseases, will be evaluated in more depth. Any smoking history past or current should be disclosed. You must detail all medications, herbal preparations and any allergies as the adjustment is often needed at the time of surgery.

After discussing the woman’s motivation and desire to final appearance a full breast examination will be performed. This will include a clinical check for any pre-existing breast lumps. The cosmetic assessment requires a trained eye and the experience of Mr Turton is invaluable here. The measurements taken will be recorded on and kept in the notes. In particular any asymmetry of the chest or back is noted as if there is some element of asymmetry of the breasts at the start of the procedure due to minor physiological differences (these are common), or development or skeletal deformity then this will obviously need to be recognised as it will always have some impact on the final results. Discrepancies cannot usually be greatly altered by conventional simple breast augmentation surgery and if you are concerned about asymmetry you may need additional surgery or further surgery at a later date. A balance is usually made by patients to accept their starting asymmetry to avoid additional costs, but if it is something that you feel would be difficult to cope with psychologically you should make this clear so that Mr Turton’s opinion can be explored as to the potential solutions and what they might entail. Asymmetries will, therefore, be demonstrated to avoid any dissatisfaction postoperatively. It is worth remembering that augmentation will not produce a perfect type cleavage with nipples pointing straight ahead unless that is what the woman started with.

Specific Considerations with Breast Enlargement Surgery

Ptosis – ptosis (sagging) is the medical term for nipples that have dropped below their original position. There are various grades and in the worst cases, they can actually be pointing directly at the floor. Breast augmentation cannot correct anything other than the mildest case of ptosis. If a ptosis correction is requested then an alternative procedure known as a mastopexy would be required which can occasionally be combined with an augmentation, albeit with certain increased risks. This, however, leads to additional incisions and hence scarring around the nipple and often lower breast (see photos of mastopexy or reduction on Mr Turton’s website), dependant on which technique is required. Care should be taken to discuss this with your surgeon should you wish the nipple position to be altered. Some women are happy to live with a degree of looseness and ptosis so long as the volume of the breast can be returned with the augmentation. So long as they understand that in a bra they will have good volume and projection but once the bra is removed they will have the downward deflection of the nipples as before. At all times it should be emphasised that we are aiming to achieve what the woman wants and not some preconceived idea of perfection. If you do not have ptosis then you will not have to worry about this, although it can develop later after augmentation and sometimes it can occur just in one breast causing asymmetry. Future weight changes, hormonal changes, the presence of implants and simple ageing can all contribute unpredictably to the way the breast behaves as you get older. This can affect women who do not have implants but is generally more obvious after augmentation.

Breast Implant size

Consideration is always taken regarding the patient’s desires. Reviewing pre-and post-op pictures from Mr Turton’s web site and printing off the post-op pictures that you feel are most in line with your desires can assist the discussion.

Between 125 and 150 mls of volume will very approximately increase the bra size by about 1 cup. However, this is really too vague a relationship to serve as any useful judgment when choosing implant size. A bio-dimensional assessment will be performed by Mr Turton, to provide you with an implant size that fits your frame and therefore is more natural and in proportion, as is desired by the majority of patients these days. It is far better to base the planned implant on your tissue characteristics and more specifically your breast and chest dimensions. There are many considerations eg: the way previous pregnancies (if applicable) have stretched the tissues, your current breast size and overall current ‘starting point’. We do this by assessing the shape of your chest wall, measuring the thickness of your current breast tissue, the skin and breast tissue elasticity, the looseness of the breast skin envelope and the quality of the underlying tissues. We use this information to help decide on the optimal shape and size of the implant and whether it is placed behind or over the muscle. All of this should be carefully considered by your surgeon and taken into account before discussing implant size with the patient. A higher profile round implant will give a fuller appearance in the upper part of the breast (the extra high profile type can give a more artificial look where desired, but the moderate and full profiles can also look very natural in the context of the right starting point, and the optimal profile and size of implant chosen by your Specialist). There are also anatomically designed implants that give a less pronounced fullness in the upper part of the breast, although these don’t suit everyone, they can work very well with patients who are very thin and flat chested. You should ask your surgeon to discuss the various merits of each of these with you prior to selecting an implant. Crisalix 3D imaging is one of the most advanced ways to help guide you as to how you might look after the biodimensional assessment has allowed Mr Turton to determine the optimal implant type. This 3D image is able to show a simulation of your potential outcome.

Breast Implant type

The implants have an outer silicone shell but virtually all cosmetic breast implants have silicone gel inside. They can be saline-filled but these do not feel as natural. It must be stressed that previous concerns about silicone have proved unfounded in the Independent Review Groups Reports, with no evidence of autoimmune problems, but your surgeon will discuss things with you in more depth and ask any questions that you have. Natural oil based implants are no longer recommended. The UK market is dominated by silicone filled implants as these give a more natural look and feel. Mr Turton will use one of the high cohesive silicone gel implants, which are far superior to runny silicone (see the section on the Mentor MemoryGel Cohesive and BLite implants). Mr Turton has an extensive experience with different implant manufacturer’s implants. He has particular experience and expertise with the full spectrum of anatomically shaped (tear drop) and round implants of different profiles and LVC measurements, and their correct placement (see pre- and post-op photos).

Positioning of the Breast implant

The implant can be placed either directly under the breast in a “sub glandular” position or partially under the muscle of the chest wall known as the “subpectoral” position or “dual plane”. Generally for women with very little existing breast tissue a submuscular approach is recommended to reduce the palpability of the upper edge of the implant, or to mask visible rippling which might only appear when you sit forwards. Every woman obviously represents an individual case and you should discuss the various advantages and disadvantages of each approach with your surgeon. The sub-muscular position affords a better ability for mammograms to visualise your breast tissue later, although they are still less sensitive than when performed without implants. The breast tissue is partly obscured by cosmetic implants on mammograms. Sub-pectoral positioning can sometimes look less natural, especially if the implant is wrong for your frame. During forced pectoral muscle contraction the upper pole of the breast and the cleavage area will flatten when the implant has been positioned behind the muscle (sometimes referred to as animation of the breast as it makes the breast move). Sometimes the sub-pectoral position can stop the implant filling the overlying envelope of the breast as well, if the envelope is quite loose to start with. Although it is not uncommon for the breast to look and move unnaturally when contracting the pectoral muscles, giving a distorted appearance, this is only really visible if you do this deliberately or when wearing just a bra or are undressed! Sub-pectoral positioning may help lower capsular contraction rates and it is the preferred position for smooth shelled implants which are a popular choice for their lowest risk of ALCL. Some patients prefer sub-glandular positioning as it is less painful and the recovery is quicker, and they “reserve” the sub-pectoral position for later in life when they may have revisions. It is good to have a detailed balanced discussion about this with Mr Turton.

Breast Augmentation – The Operation

You must not smoke either before or after surgery ideally from 6-weeks before to 6-weeks after. Smokers have higher rates of all complications both in the short and long term. All nicotine products must be completely avoided. The operation is performed under a general anaesthetic and in Mr Turton’s practice is always conducted by an experienced Consultant Anaesthetist as safety is his priority. Various approaches are available for the placement of the implant. The commonest approach is by placing the scars underneath the breast in what is called the inframammary position. This is generally considered the one required for the placement of silicone implants as they do not compress enough to be squeezed through holes in either the armpit or around the nipple. It is associated with the lowest complication rate. Your surgeon should discuss the surgical approach with you prior to the operation. Mr Turton has very careful and skilled technique for breast augmentation that has been refined from years of experience and will help optimise the best cosmetic result for you and reduce the risk of subsequent complications. The stitches used are dissolvable. Mr Turton uses three layers of sutures, with the deepest strength layer designed to be reabsorbed slowly by the body and usually complete by 6-months. The top layer is a fine cosmetic suture just under the skin surface to optimise your scar.

Following the procedure, the wounds will be dressed with white adhesive strips called steristrips and over this, a semi-waterproof dressing will be placed. This will protect your wound, but Mr Turton prefers that you just take shallow baths for the postoperative 1-2 weeks to keep the dressings dry. A Tubigrip support is pulled up over the breasts at the end of the operation so that no sports bra is needed at this time, as this is generally preferred to prevent possible implant malposition from an ill-fitting bra. The Tubigrip and “stabilising band” should not be removed, but left on even when having a shallow bath (and kept dry!). They should be comfortable and not excessively tight. The Tubigrip is often placed as a double layer for the first post-operative night, and then pulled out to a single layer and the bottom trimmed the following morning so that it isn’t as tight. An overnight stay is generally always recommended as Mr Turton believes this to be the safest way to look after you and for your reassurance. Antibiotics are given to cover the procedure and for a period of 3 days afterwards.

Returning Home after Breast Enlargement Surgery

You normally need regular combination analgesia with sub-muscular augmentation for the first four days (eg a common combination is: Paracetamol and Ibuprofen (sometimes also Tramadol) all taken every day for four days before decreasing a little). The patient is advised that she should restrict her arm movements for the first 7 days trying to keep her elbows close to her sides. On the eighth day you can resume routine non-strenuous activities but should still restrict arm movement; You can usually drive a car again a little earlier than this if it is not uncomfortable to do so. However, you must avoid lifting your arms above shoulder height.

You will be reviewed at around one week after surgery in the dressing clinic and then at around two weeks after surgery in the out patients department. At the end of 2-3 weeks, you will be advised when you can start to wear a sports bra. Usually by 6-weeks you can start to wear an under-wired bra, thought you may consider continuing to wear the sports bra at night (which may help reduce breast sag in the long term if you keep it up regularly). If all is well you can resume most normal activities including light exercise at 6-weeks, except when a shaped (anatomical) implant has been used when the period of restriction is far longer to reduce the risk of implant rotation. Swelling usually resolves by 3 weeks but can take 6-8 weeks with sub-pectoral placement and for implant settling to occur. It is worth remembering that exposure of the scars to ultraviolet light will produce permanent pigmentation in the scar. It is therefore advised to avoid tanning booths and exposure of the scars to sun until the scar has gone a white colour, which can take 6-12 months or occasionally two years.

It is very important not to poke around the scar area with your fingers and under no circumstances scratch the area. Doing so can initiate inflammation, protrusion of the suture ends and cause a deep infection leading to implant removal.

Routine massage of the implants (as used to be described for smooth shell saline implants) is not recommended or required and may encourage capsulation. Please do not do this under any circumstance. Please also ensure any sexual breast contact is gentle.

Keeping the scars taped with a thin strip of low allergy tape such as Micropore™, for 3 months can help reduce stretching of the scar whilst it matures, and hence help to keep it as imperceptible as possible. If you have a tendency to form thickened or raised scars there are silicone gels that can be used which might be beneficial. Otherwise Dermatix gel can be used from 2-weeks and applied twice daily for 12-months for the reassurance to get the best maturation possible. Some patients just use “bio-oil” for around 3-months.

Special consideration/side effects/complications with Breast Implant Surgery

Pregnancy should preferably be avoided for 6-months after the procedure. It is normally possible to lactate and sometimes breast feed after a subsequent pregnancy after breast augmentation but a small number of women will find that they are unable to do so or that the volume of milk has reduced. It should be remembered that some of these women may not have been able to breast feed even without an augmentation. The antibiotics given during the procedure may make the oral contraceptive pill ineffective. Barrier contraception should therefore be used until an uninterrupted pill cycle is restarted.

Haematoma

In the first few hours after surgery, Haematoma or bruising is the most common complication. This is the same after most surgical procedures and occurs in less than 1% of patients undergoing augmentation mammoplasty under Mr Turton’s care. It normally appears within the first 24-hours and is associated with a sudden obvious increase in breast volume with a tight feeling and discomfort. Very small haematomas can be treated conservatively and will settle. However larger haematomas are usually treated by evacuation under anaesthetic on the same day. Avoiding moving around excessively as you come round from the anaesthetic is important to reduce the risk of this occurring.

Infection

The nationally reported deep infection rate leading to implant removal is reported at 2%, which means 2 in every 100 patients. In over 1000 breast implants placed for primary augmentation, Mr Turton has never had an infection leading to implant loss.

Minor wound healing problems may occur more frequently and minor infection with redness at the suture line would be treated as infection even if there are no other signs, and this would still be extremely uncommon at less than 2%.

If an implant becomes infected the breast would swell and you would likely feel shivery, unwell, and have a temperature. That would require urgent medical care to treat and remove the implant to prevent serious sepsis forming which could be dangerous. If an implant had to be removed for infection it would be left out for a period of months. This would produce a marked asymmetry if only one breast is affected. It is possible to place an implant subsequently, but there is an increased risk of infection with the second procedure. Not smoking is of particular importance.

ALCL

ALCL stands for Anaplastic Large Cell Lymphoma. In 2011, the American regulatory Agency (the FDA) identified a possible association between breast implants and the development of ALCL, a rare type of non-Hodgkin’s lymphoma. It was estimated in 2011 that that the FDA was aware of approximately 60 cases of ALCL in women with breast implants, out of approximately 5-10 million women who had received breast implants worldwide. The incidence is likely to rise with time but is still considered exceptionally rare and less than 1000 cases have ever been recognised worldwide as of April 2019.

In the UK our regulatory agency (the MHRA) have asked that all surgeons report cases since 2011. As of 2016, only 12 such cases have ever been recorded in the UK, and even as of April 2019 the total number of cases ever reported remains under 50. This confirms that ALCL is a very rare problem. Nonetheless, it is of ongoing patient and media interest and will be discussed more and more in the future. In the cases reported to date there are cases that have occurred in the commonest used implants such as Allergan Natrelle and even Mentor. It is too early to say for certain whether it can affect all implant types but there is data to suggest different rates with the texturing variations used by different manufacturers. For example, smooth round implants seem to be extremely rarely associated with it. However, there can be some other complications from smooth round implants such as a higher rate of capsular contraction or malposition, and this can lead to more revisional surgery. One theory about the development of ALCL is that minute traces of bacteria get trapped on the textured implant surface (a biofilm) and cause a chronic inflammation that stimulates the adjacent white blood cells in the tissue (the T-cells) and that triggers it is a subset of susceptible patients. But no one knows for sure and it may be a rare type of bacteria that has not yet been discovered, or even a type of rare autoimmunity. The frequency of occurrence does seem different in regions of the World, and overall, as of April 2019, under 1000 cases have ever been recorded World Wide!

The reason to inform you about something so rare (remember a woman’s lifetime risk of breast cancer is 1 in 8; in contrast the MHRA report the rate of ALCL to be 1 in 24,000), is that Mr Turton feels that patients should be given as full information as possible, and it would likely be more worrisome if you had not heard of it before and then to learn about it through the media. From the cases that have been reported it is treated by removing the capsule from around the implant, and at this early stage it is entirely curable. Late cases where it has been diagnosed late leads to spread, which can be fatal like any cancer. The key thing is understanding it is rare, but to be aware of it, how it presents, what you would look for and what to do if you had a concern. Late problems with implants are more usually caused by capsular contraction, minor trauma or rarely infection seromas. All of these can present with symptoms that may have overlap with this rare condition of ALCL, and it will be more common in the future to take fluid sample from around the implant if a sudden effusion occurs to look for the very rare case of ALCL that might be the cause. Updated information is available from the MHRA: https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl

There is no link with conventional breast cancer, and we know from extensive research that the frequency of breast cancer is no different in patients with cosmetic breast implants compared to the general population. Please feel free to ask more about this if desired. Please see my dedicated page on my web site about ALCL.

 

The Safety of Breast Implants

There are many hundreds of medical devices that are implanted in to patients in this day and age, from hip and knee joints, types of surgical mesh, pacemakers, artificial heart valves, biologic materials as well as breast implants to name just a few. The vast majority of patients implanted with these medical devices have no adverse reactions. The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.

Silicone implants have been used in tens of millions of women across the World since the first breast enlargement in 1962. Breast implants are some of the most regulated and investigated devices in the world. There have been large independent reviews that have looked at the safety of silicone implants. In particular the UK Independent Review Group (published in 1998) and the USA Institute of Medicine (IOM) Committee on the Safety of Silicone Breast Implants (published in 1999). Both reports found no link to autoimmune problems or breast cancer. They concluded that local complications were “the primary safety issue with silicone breast implants.” These local complications, which included rupture, pain, capsular contracture, disfigurement, and serious infection, lead to medical interventions and repeat surgeries. Importantly, the IOM report concluded that there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease. The National Science Panel concluded that silicone is of low toxicity and that the local reaction to silicone is similar to other foreign-body reactions.

In November 2006, the FDA approved Allergan’s Natrelle Silicone Gel-Filled Breast Implants and Mentor’s MemoryGel Silicone Gel-Filled Breast Implants. The FDA based its approvals on the manufacturers’ clinical studies, called Core Studies, which followed hundreds of women with silicone gel-filled breast implants for 3 (Mentor) or 4 (Allergan) years. The last FDA Update on the Safety of Silicone Gel-Filled Breast Implants was published in 2011. They identified that most infections develop in the immediate post-operative period, although infections can develop long after implant and may be underreported. The current body of literature did not support an association between connective tissue disorders and silicone gel-filled breast implants, but most of the available studies have limitations. Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labelled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Most women report high levels of satisfaction with their body image and the shape, feel and size of their implants.

Although existing data do not allow the definite exclusion of systemic or local immune responses associated with silicone breast implants, no valid scientific evidence currently establishes any such association. In fact, the nature of science is such that no scientific data can ever allow the definite and unexceptional exclusion of this possibility. Based on the  evaluation of the FDA and discussions with experts elsewhere in the government and academia, we believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials in implants in general (not just breast). The symptoms some patients experience may be limited to the region where the device is implanted or may be more generalized. Symptoms include but are not limited to fatigue, rash, joint and muscle pain or weakness. Although uncommon and varied, these symptoms may share common underlying immune/inflammatory pathways and mimic more well-established inflammatory conditions. In the small subsets of patients who have reported these symptoms, the symptoms may not develop for several years following implantation. As a result, they may not be detected even in larger and longer clinical studies. To date, these symptoms have not been reported with most materials used in medical devices, including most metals. Moreover, when reported, they have tended to be limited to small subsets of patients. As an example, some patients, mostly with a history of pre-existing allergies, may develop allergic skin lesions with certain device use. This risk is usually identified by patch testing for potential device material-related allergens. However, not all device-related reactions are allergic in nature.

Some patients have reported to the FDA concerns that their breast implants may be connected to other health conditions that could be associated with their immune system’s response to these devices, resulting in symptoms like chronic fatigue, cognitive issues and muscle pain (like a breast implant illness). While the FDA doesn’t have definitive evidence suggesting breast implants are associated with these conditions, they are looking to gain a fuller understanding of this issue to communicate risk, minimize harm and help in the treatment of affected patients. Mt own view is that we can’t 100% exclude the possibility that implants make some patients ill or might set off an autoimmune disorder, and even though I have never personally seen this is any of may augmented or reconstructed patients in over 15 years, if a patient was to get such symptoms they may have to accept that implants are simply not for them and have them removed as a precaution. Mentor explore safety data further on their web page on implant safety: http://www.mentorwwllc.com/global-us/SafetyInformation.aspx

Nipple Stimulation

Approximately 15% of all patients undergoing primary augmentation will have permanent alteration in sensation on one or both sides. This can involve the nipple, the areola (the brown skin surrounding the nipple), or more commonly some of the skin on the breast itself usually across the lower pole. It may be less sensitive or totally numb. It would be considered permanent if it has still not returned after a year and even removing the implant will not bring it back. Women should therefore be honest about the importance they place on nipple simulation on their sex life. If it is important to the woman then she should consider whether this operation would be advisable given the risk of nipple sensation loss.

Rippling

If the soft tissue coverage of your skin, fat and breast tissue is insufficient to mask the implant properly, unsightly ripples may appear in the skin on the front upper part of the breast, or on the outside and inside of the breast particularly when the breast is in a dependent position (eg when sat upright and bending forwards or bending down). This is usually due to the wavy surface of the outside of the implant and across its upper half, when someone is sat upright (implants are not solid plastic structures, and the surface adjusts according to pressure and support on the shell). It can also be due to adherence to the underlying implant when very textured implants are used, but usually it simply relates to the patient having such thin tissue coverage. In essence it is because implants aren’t 100% taut or solid like a rubber ball. Submuscular (under the muscle) rather than subglandular (under the breast) positioning reduces this complication and is recommended if there is little natural breast tissue to cover the implant. It is not always possible to prevent this, but Mr Turton will look at your soft tissue thickness with tissue callipers during the assessment.

Palpable Implants (edges, knuckling, folds, kinks)

Occasionally the top or edge of the implant can be felt as a definite step or fold under the tissue. Submuscular placement reduces this problem but in athletic individuals can lead to cosmetic problems when the chest muscles (pectorals) are tensed. In addition to alternative implant positions the newer biodimensional implants (also called “anatomical” or “shaped”) have a less pronounced “take off” than the round prosthesis and have a stiffer gel. Whilst they give less fullness in the upper and inner cleavage they can give a more natural shape to your augmentation if you are incredibly thin or flat chested. These may be particularly appropriate for women with little breast tissue in the upper part of their breasts, where the tissue thickness as measured with callipers on a pinch test is 10mm or less. You should ensure your surgeon discusses these points with you. Folds can appear over time, with capsulation.

Capsular Contracture and Removal of Implants

A contracture is a tight fibrous capsule that the body forms around the breast implant causing it to become less natural looking. Approximately 1:4 women will develop some form of contracture around the implant. Whilst most women will not realise there is a thick capsule that has formed, occasionally the contracture becomes so bad that the implants require removal. The incidence of contracture is falling with only 10-20% of women developing it over a 10 year period, but follow-up data in this group remains imprecise. Various conservative treatments have been suggested including the use of antioxidants such as vitamin E, however nothing is fool-proof and a certain percentage of patients will develop contracture no matter what they do or how many times they undergo revision procedures. Women should be aware of this before undergoing breast augmentation. However a small amount of capsular contracture is very common and often accepted by other women undergoing this procedure. If a tight or hard capsular contraction occurs you should have it removed as fully as possible if having replacement implants. My advice is also that if you develop capsular contraction a second time, you should consider removing and not replacing the implants, and simply accepting that implants are not for you. When implants are replaced after a capsulectomy procedure has been performed, the breast shape will change noticeably. It will be less full and you will notice that the breasts and implants have dropped, as there will be more looseness. If you ever have the implants permanently removed in the future after any previous augmentation then the breasts will usually look drooped and flat, and quite commonly worse than if you had never had them in the first place. The weight and compression of tissue from the implants contributes to the droop and emptiness.

As heavy texture is associated with a higher risk of ALCL, micro texture and smooth implants are options. Sub muscular smooth implants probably develop capsular contraction at similar rates to sub glandular textured implants, but there are no good studies that have been conducted. Pregnancy and breast feeding after augmentation can cause capsular contraction. This may be because of bacteria from sub-acute infections. Prophylactic antibiotics should be considered for invasive procedures such as deep root canal dentistry if you have implants. There have been various conservative treatments suggested that women could try to reduce the general risk of capsular contraction including the use of antioxidants such as vitamin E, however, nothing is foolproof and a certain percentage of patients will develop contracture no matter what they do or how many times they undergo revision procedures. Women should be aware of this before undergoing breast augmentation. However, a small amount of capsular contracture is very common and often accepted by other women undergoing this procedure. If a capsular contraction occurs you should have it removed fully if possible if having replacement implants. This can cause the breast shape to change and drop with more looseness. If you ever have the implants permanently removed in the future after augmentation than breasts will usually look worse than if you had never had them in the first place, with droop and emptiness.

Micropolyurethane covered silicone implants are thought to have the lowest capsular contraction rates, but there

Micropolyurethane covered silicone implants are thought to have the lowest capsular contraction rates. But they are harder to place, and usually a longer incision is required to get them in. Silimed manufactured these but they had their licence withdrawn a few years ago as there was some powdery silicone residue found on the implant surface, presumably due to their manufacturing technique. The polyurethane implants are available from a German manufacturer called Polytech. These implants can provide a useful resource for complex revisions as they do not rotate or move around in the implant pocket. However, the link to breast implant lymphoma may be highest with this variety so caution and detailed discussion must be used if they are to be used. In other words their use must be clearly justified. The Australian data on ALCL showed that the risk of BIA-ALCL was still very low, but more common than other implants at around 1 in 2400 implants. There is also a theoretical excess risk of breast cancer of 1 in a million with these implants, which is of negligible significance compared to the normal rates of breast cancer of 1 in 8 in a woman’s life span.

One modern theory on capsular contracture is that some occurrences are caused by microscopic contamination of your implant by bacteria from the environment or from your skin or the nipple ducts at the time it is placed in the operating theatre. Mr Turton therefore uses an intricate 14-point protocol to reduce this risk, comprising items such as nipple shields, glove changes, alcohol-chlohexidine skin preparation, no-contact implant placement, use of the Keller funnel, betadine, gentamicin, cefuroxime triple antibiotic/antispeptic rinse. Mr Turton has recorded a very low capsular contraction rate in his patients and has never had a case of BIA-ALCL.

Rupture / Deflation / Replacement

With saline implants (rarely used by Mr Turton expect as part of initial stages of some breast reconstructions where these are called tissue expanders) there is the risk of sudden deflation and even with silicone implants no women should regard her initial augmentation as being life long. It is possible that at some stage the silicone implants will have to be adjusted, replaced, or permanently removed. If you have not had any earlier problems, Mr Turton advises patients to strongly consider renewal at the 10-year mark. Some patient might change them earlier, for a size changes, or for problems of rupture or gel “bleed” (the name given to the slow diffusion of silicone out of its covering), or capsular contraction or malposition. Given the continued development of new implant designs it is difficult to predict the expected lifespan but it is certainly longer than with the older designs, but safety concerns have increased. Replacement surgery is far simpler with a non-ruptured implant without complications.

 

With saline implants deflation can occur slowly or the prosthesis may rupture causing a dramatic deflation. With silicone implants any loss of integrity in the outer shell is generally compensated for by the fact that the body forms a capsule around the silicone – this is referred to as “intra-capsular” rupture. This was not uncommon with the older implant designs and is normally asymptomatic and silent. With the more modern high cohesive gels it is extremely unlikely that any silicone would travel any distance from this capsule unless the rupture was left for a considerable time. The inside of the high cohesive type is more like a set jelly, rather than runny silicone. But with a more prolonged period of rupture some more liquid type silicone can come from the surface and be adsorbed into the surrounding capsule scar. This might incite a stronger inflammation and set of capsular contraction, or it might trigger watery fluid to form crating an effusion that then requires testing. You might get a burning feeling too. But if there are no symptoms, it might only be discovered incidentally when the implants are renewed. A neglected rupture can lead to silicone passing through the capsule and permanently into surrounding tissues, lymph nodes and elsewhere in the body. I specifically recommend the use of high cohesive implants and also strongly reinforce the advice that even if you have had no problems with the implants you have them replaced after 10-years. One of many reasons that I recommend this is that the rupture rate is thought to be around 10% within the first 10-years after augmentation, based on MRI studies, ad dealing with any earlier problems is usually much more straightforward.

It should be remembered that having breast implants does not stop the usual involution (shrinkage of breast glandular tissue with thinning) that occurs following pregnancy or with advancing age. Indeed correcting the aesthetic problems caused by these processes is often the reason women request implants in the first place. Ultrasound scans can be used to look for rupture but MRI is more accurate. Both investigations are expensive (USS around £300, MRI around £900). In the USA, they recommend MRI after 3-years and then repeated every 2-years thereafter. This has never been the position in the UK, though if patients want to pay for these tests they are available. However no test is 100% accurate- Mr Turton has operated on patients where the test has suggested a rupture but there hasn’t been one and vice versa. Patients with breast symptoms should always be referred to the breast clinic by their GP for prompt assessment by a specialist.

Scarring and Pain

Obviously there is always the risk of overgrowth of the scar known as over granulation. This is called a hypertrophic scar and it is a little raised and a little thicker and more noticeable than normal. In extremely rare cases Keloid scarring can occur, although Mr Turton has never seen this in over 15-years of carrying out breast enlargement surgery.  If the scar is hidden under the breast this becomes less of a problem but it can be quite dramatic. In over 99% of cases the scar is usually very fine and fades beautifully over the course of a year. Very occasionally women can get an uncomfortable chronic ache on one side or another after augmentation, and is almost certainly related to deep scar tissue or trauma to sensory nerves. Most patients report that the breast implants feel part of them by 6-weeks after augmentation and that they are not aware of them. If you were to get chronic pain, it is sensible to have them removed and accept they are not for you..

Double bubble

An unexpected visual cosmetic result of a double bubble near the crease under the breast can very occasionally occur leaving a less than optimal cosmetic result. This double bubble appearance is slightly more common with pre-existing ptosis (sagging), or with a pre-existing constricted (tuberous) breast. I also think the shaped implants placed under the muscle can make it more likely to occur when the predisposing starting points are seen. It is also more common where the crease under the breast is very well defined as the condensed tissue (fascia) fails to expand naturally over the lower part of the implant. Although it may improve spontaneously over a number of months you may need to pay for revisional surgery.

Granulomas

It is rare but possible that small lumps may appear over the implant due to the reaction of the body to foreign materials such as silicone. However any lump occurring in the breast whether it has been augmented or not should be appropriately investigated urgently through the NHS breast clinic. Your GP would normally refer you using the “2-week rule”.

Malposition

If an implant moves too far to the side or becomes too low falling beyond the crease under the breast, it is referred to as lateral or inferior malposition. It means the implant no longer in the ideal position. It can occur due to problems you’re your breast tissue simply being too loose to hold the implant securely. Also as we are now not tending to use the type of implants with heavily textured surfaces, implants do not adhere to the tissue and are more like a wet bar of soap and quite slippery under the surface of your breast tissue. Malposition can also occur with technical error during surgery- eg when the incision was placed in the armpit it was much more common to find the implant was malpositioned as the surgeon couldn’t check the placement as accurately. However, as gravity affects breast tissue and implants weigh more heavily in the pocket causing tissue stretch, malposition can gradually occur over time. This may lead to a bottoming out appearance. Corrective surgery will not always work effectively as it can occur again and is also associated with the costs of revisional surgery. Choosing implants that are too big will encourage malposition. There is some evidence that the micropolyurethane coated anatomical implants are associated with a lower rate of rotational malposition (personal communication) but there are some difficulties with initial insertion though small incisions and the trade-off if using these is the association with breast implant lymphoma is around 23 times higher than with microtextured implants, with an overall rate in the Australian series of around 1 in every 2400 cases.

The BLite lighter weight implants are around 30% lighter than standard silicone implants and although they are more expensive being a premium product, patients can consider them for their breast enlargement.

Subsequent Breast Investigations

It is easier to investigate an augmented breast that has had a subpectoral implant (rather than subglandular) placed as obviously the breast tissue is pushed forward by the muscle. Even with sub-glandular implants it is usually possible to perform breast examination and breast biopsy so long as the investigating clinician is aware of the presence of implants. However implants do interfere with mammography and specialist views are required. The detection rate of small non-palpable breast cancers on screening mammography is probably lower when implants are present. A woman should inform her mammographer that she has implants in place so that the proper studies can be done. It is slightly easier to perform mammographic views on a subpectoral implant than on a subglandular implant. Prior to augmentation if the woman is of a more mature age or there are any significant risk factors for breast cancer such as the family history, then mammography may be performed as a screening investigation. Mr Turton can usually arrange a private screening mammogram in women over 40 who have not got any breast symptoms or lumps for approximately £250.00

In Conclusion

Any woman considering augmentation mammoplasty should consider the following points as regards the recent negative publicity over silicone breast implants.

  • There is strong evidence that implants do not cause breast cancer.
  • Implants are not lifetime devices. The rupture rates are around 10% and capsular contraction rates are around 10-20% within 10 years.
  • ALCL is a rare type of lymphoma that is definitely associated with textured implants. Data as of 2019 suggests it occurs between approximately 1 in 1000 and 1 in 30,000 women. There may be a rare link to smooth implants but this is far less common.
  • There is weak evidence that silicone implants may cause autoimmune disease or in rare cases a vague set of illness type symptoms. You should have them removed if that occurs.
  • A general change in the cosmetic appearance is likely to occur with time and you should assume that revisional surgery will be needed at some point in the future. A degree of breast sag can occur early after an implant has been placed and initial fullness can therefore decrease- tissue stretching is more common in women whose breasts had become much bigger during a pregnancy. Tightening the skin again is called a ‘mastopexy’ and is an option but involves scars around the nipple, down the front of the breast and across the crease, so as to remove the loose skin.
  • The longer a woman has silicone gel-filled breast implants, the more likely she is to experience local complications or adverse outcomes. As many as 1 in 5 primary augmentation patients and 1 in 2 primary reconstruction patients require implant removal within 10 years of implantation.
  • Limitations in the post-approval studies to date preclude the detection of very rare rates of complications. However, post-approval studies to date do not show any definite evidence that silicone gel-filled breast implants cause connective tissue disease or reproductive problems.
  • Breast augmentation remains a viable surgical intervention for women who appropriately select this procedure and are counselled concerning its possible effects. If there is any doubt we recommend that you discuss the options with your specialist.

Additional Information

Remember:

    • If you can feel your ribs in front, underneath or beside your breast you will be able to feel the edge of your implant.
    • If feeling the edge of an implant shell could be a problem, do not have an augmentation.
    • If you are thin or have very little natural breast tissue you will be more likely to feel your implant, or to get rippling. Sub-muscular placement is more likely to reduce this unwanted problem.
    • The larger your implant the worse your breast will look over time. A larger implant will stretch your tissues over time and cause more tissue thinning and sagging than a smaller implant. Visible “rippling” may also occur if you chose a large implant relative to your current breast size.
    • No augmentation will provide a totally natural breast. Patients often have asymmetry and this persists or can look more noticeable after augmentation. This is particularly the case with respect to nipple position.
    • It is vital that you arrive at a realistic expectation of what can be achieved with the various breast implants.
    • Two weeks before surgery we encourage consumption of pineapple (mainly the core part). This is because there is evidence of an anti-inflammatory effect due to Bromelein contained in pineapple. Always disclose all gels, tablets and medication that you are taking including herbal remedies-some increase the risk of haematoma (bleeding) and must be avoided prior to surgery.
    • Please avoid these in the week before surgery:
      1. anti-inflammatory drugs: like Ibuprofen, Neurofen, Diclofenac and aspirin.
      2. Herbal remedies and vitamins: St John’s Wort , Vitamin E, Vitamin C, Gingko Biloba, Echinacea, Garlic, Willow Bark Products.
      3. Others: antidepressants, warfarin, steroids, vioxx, or pain killers
      4. Please also avoid: Avocado, Ginger, Broccoli, Garlic, Vegetable oils, Nuts & seeds (high concentrations of vitamin E)
    • Please ensure that any issues have been discussed with your surgeon to your satisfaction prior to undergoing breast augmentation.
    • Please do not have breast implants if you are known to have or think you might have body dysmorphic syndrome.

Note: This information is for general guidance only and represents the views and opinions of Mr Turton, Consultant Breast Surgeon. It should in no way be regarded as either definitive or representing the views of any other surgeon, doctor or institution.

Further useful information is available on the internet from Mentor and Allergan, two of the leading manufacturers of breast implants; And also from the Department of Health detailing safety issues and complications relating to breast augmentation and implants: https://www.gov.uk/drug-device-alerts/medical-device-alert-breast-implants-report-cases-of-anaplastic-large-cell-lymphoma-alcl
https://www.gov.uk/government/publications/breast-screening-breast-implant-guidelines
https://www.gov.uk/government/news/recommendations-to-protect-people-who-choose-cosmetic-surgery