Allergan Breast Implants

Allergan Breast Implants: Latest Updates and Insights from Philip Turton, Leeds Specialist

The Allergan implants formally comprised the broadest product range.
As of December 2018 we do not use any of the macro-textured Allergan breast implants as the macro texturing has a higher linkage to the uncommon BIA-ALCL.

Allergan therefore withdrew their entire range of implants from the market. The smooth shelled implant was unaffected as the safety consideration related to the textured surface of their other implants. The whole textured range is therefore withdrawn in Europe. The heavy macro texturing of an implant is no longer generally advisable when there is an alternative and in the current climate of BIA-ALCL, we recommend you consider these alternatives including smooth shell implants or microtextured where the risks of this uncommon malignancy is lower.

The pros and cons should be considered carefully so that an informed choice is made. The most natural and aesthetic beautiful results possible can be achieved when combining the right surgeon with the right patient using the right product. Mr Turton finds he can produce a superior result with the products available with the special techniques he uses and with appropriate patient selection; Mr Turton will talk you through the selection process and share his very extensive experience with breast implants to help you make the right choices.

Allergan Breast Implant Range: Covered by the Manufacturer’s Limited Lifetime Warranty

Allergan stated that they will provide a free replacement implant if there is ever a rupture (although the cost of the surgical replacement is not covered and be aware that is the major cost).

As a comparison, the PIP implants were reported in the French vigilance study to have a rupture rate as high as 10% at one-year. By contrast, the formally FDA-approved Allergan implants had a rupture rate of just 10% at 10-years in the FDA MRI study, and lower still in other published single surgeon series.

Please read the warranty details- a PDF copy of their warranty is available here.

A schematic that highlights the Allergan breast implant product and the special barrier layer in the Allergan implant shell is also shown here. Mr Turton has been an invited consultant for Allergan on a few occasions, presenting at a few educational National meetings but has no ongoing commitment to the company, nor does he own any shares.

The above photo is from an Allergan Medical Institute event on Surgical Aesthetics which Mr Turton both chaired, lectured at and performed a live demonstration on a patient, demonstrating how to select the correct implant for your patient.

Also in the picture are international experts Bill Adams and Arthur Swift, who gave state of the art lectures promoting excellence in clinical practice.

Mr Turton has previously visited Bill Adams in Dallas and developed experience in using the Smooth Shell Breast Implants.

As of 31st October 2019, critical updates have emerged regarding Allergan breast implants.

This information is essential for patients and those considering breast augmentation or reconstruction surgeries.

Mr. Philip Turton, a leading onco-plastic breast surgeon based in Leeds, offers comprehensive insights into these developments and what they mean for patient safety and care.

The Expiry of CE Certification for Textured Allergan Implants

The CE certificate for Allergan’s textured breast implants and tissue expanders expired on 16th December 2018. This was followed by a worldwide withdrawal of these implants on 24th July 2019.

While the withdrawal does not impact patients who already have Allergan textured implants, regulators have initiated this action to prioritize patient safety. The withdrawal was of stock from hospitals, and not a patient recall.

Emerging studies have indicated an uncommon but notable link between textured implants and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Although the risk is minimal—a 1 in 15,000 lifetime risk for textured implants (see the MHRA website for any updates or changes in risk estimates)—the move underscores a shift towards alternatives with even lower risks.

Regulatory Oversight and Patient Safety

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) led the effort to ensure Allergan maintained a consistent approach across Europe.

According to the MHRA, there was no evidence suggesting a significantly increased risk to current implant holders, nor is removal or additional follow-up necessary for those with Allergan implants.

Alternatives and the Future of Allergan Implants

Allergan continues to manufacture smooth-shell implants, which have not been associated with BIA-ALCL. These implants, part of the Natrelle range, are CE-approved and available for breast augmentation and reconstruction.

Unlike their textured counterparts, smooth implants eliminate concerns tied to implant texturing while maintaining high standards of durability and safety. But the advantages of texturing are therefore lost, capsular contraction may be higher as well as implant malposition.

Allergan’s smooth implants use cohesive medical-grade silicone gel, reinforced by a robust barrier layer to minimize gel diffusion. This commitment to quality positions them as a leading choice for patients prioritizing safety and long-term satisfaction.

How Textured and Smooth Implants
Are Made

All of Allergan’s breast implants begin life from a range of special molds of different sizes and shapes, called mandrels. These are dipped into medical grade silicone to create several layers, including a middle barrier layer, and then cured to form the outer shell.

There is a hole in the back of the shell through which silicone is injected to a pre-determined volume. A round silicone patch is used to create the seal. At this stage the implant is smooth on the outside and the process is already complete if the implant is destined to remain as a smooth shell implant.

If a textured implant is being made, the implant is dipped into silicone again, and then pressed into salt crystals of a pre-determined size. The salt crystals are then washed away leaving the textured surface. The standard texture in their main range of Natrelle round and anatomical implants is called ‘Biocell’.

This is often referred to as a macro-texture these days. It has previously been used very favorably by surgeons to allow accurate positioning of implants and to prevent them moving out of place. This texture generally integrated well with the breast tissue so that it didn’t slide around.

Although the macro textured implant was withdrawn, there are some other different types of texture available with other Allergan implants. Allergan had been planning to expand their range to offer more choice in 2019 by introducing a less textured surface called ‘Microcell’.

This was because of changing trends, moving away from the most textured ‘Biocell texture’

The risk from textured implants is being thoroughly researched to help understand more about it. Fortunately for those small numbers of cases where a lymphoma forms next to the implant, when caught early, it is readily treatable by simply removing the implant and the surrounding capsule scar.

This is because the lymphoma cells appear to form on the inner aspect of the scar initially, (not in the breast tissue) and usually causes a build up of fluid around the implant making an obvious breast swelling as a warning sign.

Allergan breast implants undergo a meticulous manufacturing process:

Smooth Implants: Created by molding silicone layers to form a seamless shell.
Textured Implants: These undergo an additional process where silicone-coated molds are pressed into salt crystals. The crystals are later removed, leaving behind a textured surface, such as the Biocell macro texture or the anticipated Microcell micro texture.

These innovations have allowed surgeons to tailor implants to patient needs, balancing aesthetic goals with implant stability.

Pros And Cons of Smooth versus Textured Breast Implants

This is a complex area and the information I base decisions on in 2025, even compared to 2018/2019, is far different to that from earlier years. We now need to look at the very latest information relating to the benefits and drawbacks of each type, to weigh this up against the individual situation for your surgery, and make a balanced decision that suits you best.

Implants can cause complications in the long term, some minor but others that are less common but can be significant. So from a safety perspective, choosing the right surgeon, the right implant and right technique is very important.

There are a number of published reports and studies from 2017 and 2018 that I am very familiar with, which guide evidence of benefit of one type over another. I am also aware of the literature every year since then.

On the whole the European market had traditionally been dominated by the use of macro-textured products and conversely the USA market by the use of smooth shelled products.

The pros and cons of smooth versus ‘micro texture’ versus ‘macro texture’ relate to a host of characteristics that you and your surgeon should consider and that your surgeon can advise you on; much of this information relating to rare problems is quite new in 2018, so you must ensure you see a specialist when discussing these points.

There are trade-offs with making these choices between having benefits in some areas with one particular surface characteristic and drawbacks in others. Texture might be considered to reduce implant movement, malposition or some capsular contraction events.

For sub-glandular implants there is evidence that the capsular contraction rate is lower if a textured implant is used compared to a smooth implant.

On the other hand, it might be preferable to select a smooth implant if you opt for sub-muscular silicone breast implant placement. The capsular contraction rate seems to be similar between textured and smooth implants in a sub-muscular pocket.

If you need an anatomical implant you need to decide between different types of texture, otherwise the implant might rotate if it was just a smooth surface. Speak to your surgeon about the pros and cons regarding Mentor’s Siltex texture or Allergan’s more pronounced Biocell macro texture.

My advice since 2018 is to take account of the risk of BIA-ALCL (see below), and to avoid the more aggressive macro textured implants now and consider the evidence for the lowest risk of occurrence of ALCL first of all.

But you do also need to weigh up if a micro texture or smooth implant should be used as there are potential drawbacks with all implant devices and there is no perfect type that is suitable for all patients in all circumstances.

It is very important that you consult with a knowledgeable specialist surgeon, like Mr Turton, to discuss this.

Risks and Safety of Textured Implants

On the whole the European market had traditionally been dominated by the use of macro-textured products and conversely the USA market by the use of smooth shelled products.

Understanding the Natrelle Implant Range

The Natrelle range earned a reputation for quality and safety, offering 900 implant options. These included anatomical and round designs in both smooth and textured variants. Notable features included:

Durability: Fatigue testing subjects implants to 2 million compressions to ensure strength and integrity.
Safety: Low rupture rates (1.7% over eight years) and extensive quality controls (93 tests per implant).

Patient Satisfaction: Over 96% of augmentation patients report positive outcomes, improved self-esteem, and enhanced body perception up to 10 years post-surgery.

Risks and Safety of Textured Implants

Choosing between smooth and textured implants depends on individual goals and anatomical considerations:

Smooth Implants: Preferred for sub-muscular placement due to their lower risk of capsular contracture. They also have no known association with BIA-ALCL.
Textured Implants: Offer better stability and are ideal for sub-glandular placement or anatomical designs. However, they carry a slightly higher risk of complications like ALCL.

Discussing these factors with an experienced surgeon, like Mr. Turton, ensures a personalized approach to implant selection.

BIA-ALCL: Understanding the Risks with Mr. Turton

BIA-ALCL is an exceedingly uncommon lymphoma of white blood cells in the capsule tissue surrounding the implant. It is treatable when detected early, often requiring the removal of the implant and surrounding scar tissue.

The risk varies by implant type:

Smooth Shell: No confirmed cases reported on their own.
Microtextured: Estimated risk range 1 in 15,000 to 1 in 60,000.

Macrotextured (Biocell): Estimated risk ranges from 1 in 1,000 to 1 in 3,000.

Rupture Resistance: Strength and Durability with Mr. Turton

In this test the implants are compressed under an extreme force of 250Kg which is ten times the recommended maximum force of a routine mammogram.

Long term durability- extensive EU and US studies demonstrate that Allergan’s Natrelle silicone filled breast implants have low long-term rupture rates. 1.7% rate at 8-years median implantation time (n = 163) Heden P et al, (2009) Long term safety and effectiveness of style 410 highly cohesive silicone breast implants.

Aesth Plast Surg. 33, 430-436. However, I am also aware of MRI studies that suggest there is a silent rupture rate that is similar to other manufactures that is probably around 10% by the 10 year mark, which is why I think patients should consider regular checkups or renewal.

Long-term patient satisfaction across all aspects of breast surgery at 10 years with 96.2% of augmentation patients and 87.5% of revision augmentation patients being satisfied stating that breast implantation had been advantageous.

Up to 11-years after surgery most patients reported improved self-esteem, body perception, feeling of wearing clothes, personal charisma and attraction ability (Maxwell G P et al, (2015) Ten-year results from the Natrelle 410 Anatomical Form-stable silicone breast implant core study. Aesth Surg J. 35(2): 145-155

Why Choose Philip Turton?

With the latest research and an evidence-based approach, Philip Turton provides expert guidance tailored to each patient’s unique needs. His expertise with implants is nationally recognised and he is a leading authority on BIA-ALCL, contributing to published National Guidelines, which he wrote.

His dedication to patient safety, combined with years of experience, ensures the best outcomes for breast augmentation or reconstruction.

Consult with an Expert

If you have concerns about Allergan implants or wish to explore alternatives, schedule a consultation with Mr. Philip Turton in Leeds.

As a trusted specialist, he prioritizes safety, satisfaction, and long-term well-being for every patient.

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