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Textured Implant Statement and Advice 

 

19 December 2018 - A statement by The British Association of Aesthetic Plastic Surgeons (BAAPS) on the withdrawal of Allergan (Natrelle®) textured implants

BACKGROUND
Over recent years, plastic surgeons have become aware of and studied a known link between breast implants that have a textured surface and the condition Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). 

BIA-ALCL is rare and, usually, eminently treatable. Current research suggests the risk of developing this condition in the UK is approximately 1 in 24,000 breast implants sold. For comparison the general incidence of breast cancer in the UK is 1 in 9 and affects women with and without breast implants equally. More guidance on BIA-ALCL can be found here.

Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, hence it is difficult to draw definite conclusions at this time. Texturing of an implant surface also offers advantages, particularly with more anatomically shaped implants. Hence many surgeons in the UK still advocate the use of textured implants for their patients. It is vital however, that the risks of using textured or smooth surfaced implants are fully discussed with all patients prior to surgery so that patients are able to make informed choices.

Several different companies manufacture breast implants for both aesthetic and reconstructive use. These implants can have different types of texturing on their surface and some research has indicated that BIA-ALCL might be related to a particular type of texturing or manufacturing processes. One major company, Allergan, produces implants known as Natrelle® with a surface called Biocell®. These implants are available worldwide but can only be sold under licence.

In Europe, all medical devices are regulated and must have a stamp of safety or licence. This is known as a CE mark. All manufacturers are periodically required to apply for re-certification of their CE mark to continue to supply their devices for patient use.

THE CURRENT SITUATION
Due to concerns over the possible link with Allergan’s textured surface (Biocell®), the CE mark has not been re-awarded for this product. Hence from late December 2018, Allergan’s textured implants are no longer available for patient use. This is a precautionary measure until more data becomes available and Allergan continues to work with the authorities to clarify the issue. The BAAPS has advised its member surgeons not to insert Allergan textured implants from today.

The CE mark for Allergan’s smooth surfaced implants has been renewed and their smooth implants are not affected. The failure to renew the CE mark for their textured implants does not at this stage affect any other manufacturer.

GUIDANCE FOR PATIENTS
The British Association of Aesthetic Plastic Surgeons advises that concerned patients need not take any action at this stage. They should continue their routine follow up with their healthcare professional and discuss any questions they have about their breast implants. There is no need to remove or exchange any current implants based on the most up-to-date scientific data available. Indeed, unnecessary surgery may cause additional harm in a small number of patients.

Paul Harris, President of The British Association of Aesthetic Plastic Surgeons stated: “The news that Allergan’s CE mark for their Biocell® textured surface implants has not been renewed will be a cause for understandable concern for many patients, particularly those who have implants currently in place. It is important however to recognise that this is a pre-cautionary step taken by the regulators whilst the link between breast implant surface and BIA-ALCL becomes clear.” He continued, “We advise any patients with new symptoms such as swelling or pain to contact their implant surgeon for specific advice, otherwise they should make a routine appointment when available to discuss their concerns”.

Marc Pacifico, BAAPS Council Member and Consultant Plastic Surgeon commented: “The majority of patients in the UK with breast implants will have textured surface implants in their breasts. According to all the latest scientific data these remain safe devices and there is no indication for any woman to consider removing or replacing their implants. Patients should continue with any planned follow-up they have arranged.”

END

 

EASAPS response to “implant files”
 

The European Association of Societies for Aesthetic Plastic Surgery (EASAPS) representing the National Societies of Aesthetic Plastic Surgery understands the concerns as expressed by the research journalists in the implant files.  Medical devices implanted into the human body can cause harm and suffering for patients and should be avoided at all time.

EASAPS and the other scientific communities in plastic surgery all over the world have been focusing on Breast Implant Associated Anaplastic Large Cell Lymphoma BIA-ALCL for over 5 years and recommend that decisions regarding implant surgery in general and breast implant surgery in particular to follow guidelines based on scientific evidence rather than emotions.

Looking at all scientific data on BIA-ALCL available as of december 2018, EASAPS comes to the following conclusions:

  • BIA-ALCL is an extremely rare condition that is detectable and curable.
     
  • BIA-ALCL seem to occur in women who at some point had a textured implant.
     
  • Textured implants may still be indicated in both cosmetic and reconstructive cases in order to give the best possible results or the least overall risk of complications.
     
  • Information on BIA-ALCL should be included in the preoperative information of any patient receiving a textured breast implant.
     
  • No evidenced-based data suggest removal of any implants prophylactically.
     
  • EASAPS has no data to support banning of any of the certified breast implants currently used in Europe.
     
  • Patients with breast implants without any symptoms need to do nothing.
     
  • Unexpected swelling of the breast or a lump in the breast need to be examined by your plastic surgeon or another medical doctor.
     
  • Specific recommendations on the use of textured/smooth implants may vary between the different European countries based on their health authorities’ recommendations.
    Plastic surgeons in charge of implant-based indications should follow national recommendations until international consensus is obtained and implemented.

22 European Aesthetic Plastic Surgery Societies of 20 countries that we were able to reach support these conclusions. International collaboration with other Societies and countries continues to stay up to date of the current scientific status of this disease and other diseases that might be related to breast implants. We will keep patients and our colleagues up to date.

END 

 

Breast implant safety - 27 November 2018- Joint Statement from BAAPS/ABS & BAPRAS 

The Association of Breast Surgery (ABS)

The British Association of Aesthetic Plastic Surgeons (BAAPS)

The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS)

Breast implant safety 

An International Consortium of Investigative Journalists and a large number of media organisations around the world have highlighted what they feel to be regulatory deficiencies in bringing medical implants to the healthcare sector and their subsequent surveillance in patients.  Much of their focus has been on breast implants which are used by breast and plastic surgeons in the UK for both breast reconstruction procedures after breast cancer and cosmetic breast augmentation.

The three UK surgical specialty associations involved in breast surgery are dedicated to setting and advancing standards in breast care for the benefit and safety of patients. Breast implants are safe, but have rare, sometimes serious, side effects.  We fully support the statement made yesterday (26th November 2018) by the International Collaboration of Breast Registry Activities (ICOBRA) which aims to clarify some questions around the safety of breast implants.

The consortium of journalists has highlighted the known link between breast implants that have a textured surface and the condition Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is rare and, usually, eminently treatable. (Statement available here) Current research suggests the risk of developing this condition in the UK is approximately 1 in 24,000 breast implants sold. Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, hence it is difficult to draw definite conclusions about the type of texturing at this time. Texturing of an implant surface however conveys advantages over smooth implants, particularly with more naturally shaped implants. Hence many surgeons in the UK still advocate the use of textured implants for their patients. It is vital however, that the risks of using textured or smooth surfaced implants are fully discussed with all patients before surgery so that they are able to make fully informed choices.

We believe that the collection of high quality data on activity and outcomes in breast implant surgery is essential to informing patients about their safety.  The re-establishment of a Breast Implant Registry in England in 2016 was a positive development and we encourage our members to obtain consent from their patients to register their implant surgery. However, we remain concerned that this is a voluntary ‘opt in’ registry rather than a mandatory process for the collection of data on all breast implant surgery and also that it is not a UK wide registry. We look to the government to improve patient safety by correcting these anomalies and to confirm long term funding for the registry. 

END

 

4th April 2019 - Statement from PRASEAG on Breast Implants and Guidance for Patients

Breast cancer experts from across the UK have been working together to look at the risk to people with breast implants of developing a very rare form of cancer. This follows the news that some types of breast implants have been withdrawn in France. Based on analysis of the latest scientific evidence and on expert clinical opinion, the Medicines and Healthcare products Regulatory Agency (MHRA) advises that there is no need for people with breast implants in the UK to have them removed because there is no new evidence that the risk has changed.

The situation will be reviewed regularly by the MHRA. If people are worried following their breast implant surgery, they should see their GP or the surgeon who did the implant. This is particularly important if they notice swelling around their implant more than six months after having the breast implant (regardless of how many years later). 

The MHRA issued this advice following close working with the British Association of Plastic, Reconstructive and Aesthetic Surgeons, the Association of Breast Surgery, the British Association of Aesthetic Plastic Surgeons and other experts to assess the risks associated with breast implant associated anaplastic large cell lymphoma (BIA‐ALCL).

MHRA is also working closely with organisations doing similar regulatory work in Europe and internationally.   In addition, the independent Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) has been monitoring UK cases of BIA‐ALCL and working closely with MHRA and the information is regularly updated on the MHRA website.    

MHRA is continuing to collect evidence and investigate the disease, both nationally and internationally. Clinicians are being informed of the need to report all cases of BIA‐ALCL or suspected BIA‐ALCL to the MHRA via the Yellow Card scheme.  

 

PIP Advice and Statements 

BAAPS response to the report of the PIP implant expert group

BAAPS support the finding of the expert group, who reviewed the risks posed by PIP silicone breast implants, and welcomes the subsequent advice from the Department of Health (DoH). BAAPS were represented on the expert group by the former President, Mr Fazel Fatah.

Current advice for patients

All patients are advised that they should be aware of the make of their implants. Those patients unsure of these details are advised to contact their surgeon/ provider. Patients are advised that BAAPS agree with the DoH expectation that patients should not be charged to access their notes. All NHS patients who have a PIP implant  should be contacted by their hospital.

The only patients who need to be concerned are patients who have PIP implants.

BAAPS agree with the following findings of the expert group:

a. There is no evidence that PIP implants are responsible for an increased rate of breast cancer.
b. The evidence provided to the group to enable assessment of rupture rates is incomplete, further data is being sought.
c. There is anecdotal evidence that the gel component of the implants is less cohesive (sticky) than most other contemporary implants,
d. There is some anecdotal evidence, supported by animal studies, that the gel has a greater potential to cause local inflammation in the tissues
e. The implication of these last two findings is that the gel has a greater opportunity to interface with the breast tissue in the case of rupture and leak, and that if it does, it has a greater potential to cause irritation and inflammatory reaction within the local tissue.

Signs and Symptoms of Rupture/Leak/Inflammation in one or both breasts

Signs may include:
Lumpiness of the breast
Lumpiness/ swelling of the regional lymph nodes in the underarms and rarely in the neck
Change in shape and size of the breast
Redness of the skin
Tenderness of the breast and or the lymph glands in the underarms
Swelling of the breast
Firmness of the breast

Symptoms may include:
Pain
Hyper sensitivity

The advice to patients is that those who experience signs or symptoms of rupture or irritation should seek advice from their surgeon earlier.
Those who do not have complaints but have concerns and wish to discuss the risks and benefits of implant exchange should also seek advice from their surgeon at some stage.

Who should you go to for advice?
Patients who had their breasts reconstructed on the NHS or had private breast augmentation with surgeons or clinics who are no longer in business will be able to be seen in an NHS clinic either following referral by their GP, or following direct invitation from their hospital department.

For patients (NHS and private) with lumps in the breast or regional lymphatic tissue
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 confident that the lumps are associated with the implant or gel, referral should be made to the regional plastic and reconstructive breast surgery department. These patients should not require fast track referral.

For patients who have had their breast augmentation with PIP implants in the private sector and have no symptoms
You should contact your private provider and ask for a consultation. The government and all the surgical associations expect the private providers who used PIP implants to take the responsibility of duty of care towards their patients seriously and treat them with dignity and compassion.

Fazel Fatah, the former President of the British Association of Aesthetic Plastic Surgeons feels that the long held view of our Association, that it is advisable to remove or replace these implants in view of the inferior quality of the gel used in the manufacturing of the PIP implants, is vindicated, regardless of the rupture rate. Removal is advised as a precaution to prevent inflammation of the breast and the lymph glands in cases of rupture.

'We are also delighted that the Government now acknowledge the need for regulation of the cosmetic surgery sector and the establishment of a national breast implant register, two important developments that we have been campaigning for tirelessly for some time. Patient safety is the guiding principle of our Association.'

BAAPS feel that the current advice to patients takes account of both the available scientific data and the understandable anxieties of patients. Many BAAPS surgeons have already been asked to give advice to patients who have had their PIP implants inserted elsewhere, our members will continue to provide the most up to date advice, care and compassion.

Please click here for a link to the Joint Surgical Statement on Clinical Guidance for Patients and Doctors issued by the Royal College of Surgeons of England