December 22, 2011

expert reaction to French PIP silicone breast implants

Concern was raised over the possible health impacts of breast implants manufactured by the French company Poly Implants Prothese (PIP) using industrial grade rather than medical grade silicone.

Douglas McGeorge, consultant cosmetic and plastic surgeon at Spire Murrayfield Hospital Wirral, and council member and ex-president of British Association of Aesthetic Plastic Surgeons (BAAPS) , said:

“Problems with PIP implants have been known about for some time. Unfortunately, the manufacturer of PIP implants stopped making them to the recognised specification. As a result, they have a very high failure rate and it is likely that many patients will require implant replacement.

“The French government has recently agreed to cover the costs of replacement on French patients. Why they have chosen to do this is unclear.

“There is no medical evidence that these implants need immediate replacement. The current guidelines are that individuals with PIP implants should go back to their treatment facility, where the integrity of the implants can be assessed and a regime for monitoring planned.

“Clearly many patients may choose to have something done in advance of implant failure, knowing the problems associated with these implants.”

Kevin Hancock, consultant plastic surgeon and BAAPS council member, said:

“PIP implants are silicone gel filled breast implants manufactured by Poly Implants Prothese.

“It was noted these implants had an increased risk of complications including a high rupture rate. In March 2010 the French Medical Device Regulatory Authority suspended the marketing, distribution, export and use of these implants and after an inspection of the PIP manufacturing plant had established that implants manufactured since 2001 had been filled with a silicone gel that was not medical grade but intended for use in mattresses.

“On 31st March, 2010 the MHRA (Medicines and Healthcare Products Regulatory Agency) advised UK clinicians not to implant these devices. Test results have not shown any evidence of genotoxicity or chemical toxicity of the filler material but mechanical testing of the implant shells has shown an increased risk of rupture.

“The MHRA advised patients that they should seek clinical advice from their implanting surgeon. Although they did not recommend removal of PIP implants regular clinical follow-up and scans were recommended with removal of any ruptured implants.

“Unfortunately, due to the lack of regulation in cosmetic surgery, many patients were unaware of the type of implant they had received or had problems finding out.

“Recent reports in France have linked PIP implants with the incidence of cancer including anaplastic large cell lymphoma. It has been widely reported in the press that the French government will, on Friday 23rdDecember 2011, recommend that all women who have PIP breast implants should have them removed as a preventative measure because of health concerns about high rates of implant rupture and cancer.

“Whilst this situation does not constitute a medical emergency, patients who have concerns or questions about breast implants should contact their implanting surgeon, GP or local plastic surgeon.”

Fazel Fatah, consultant plastic surgeon at City Hospital Birmingham and President of British Association of Aesthetic Plastic Surgeons (BAAPS), said:

“These implants are mostly used in cosmetic augmentations, rather than after breast cancer.

“Any woman with these implants who have symptoms in the breasts must seek advice from their surgeon and if necessary arrange for early removal of the implants. Women who have no current symptoms or problems, but are worried, should seek advice and if necessary have a scan to look for evidence of rupture. If there is one then arrange for early removal.

“There is no indication for removal of all implants on an urgent basis as, to date, there is no known link with breast cancer. However, it is perfectly understandable if a woman with these implants wants them removed in view of the worrying publicity surrounding the implant.

“PIP implants do not meet the high standard of manufacturing compared with other brands.

“MHRA does not see a need for changing its previous recommendations as the French authorities have not produced any new scientific evidence apart from saying that the rupture rate is high and the gel can irritate the tissues and cause inflammation. It is right to advise women who have these implants to seek advice from their surgeons and come to an individual decision about the timing of removal of these implants.

“The government’s responsibility is to consider the patients first and to give sound advice based on scientific evidence regardless of the financial implications. Also there should be a continuous assessment and whenever necessary change the advice.

“As to whether the taxpayer should pay for removals, we are in a difficult situation here, the Company has gone into liquidation, therefore, there is a moral and ethical obligation by the clinics where these operations were carried out to facilitate removal of these implants whenever indicated with absolute minimum or no cost to the patients. The tax payer will inevitably pay for some them when they require urgent surgery in the NHS.”

Statement from the Medicines and Healthcare Products Regulatory Agency (MHRA): POLY IMPLANT PROSTHESE BREAST IMPLANTS (UPDATE) MHRA is aware of the recent report in France of the death of a woman implanted with Poly Implant Prosthese (PIP) Breast Implants associated with an anaplastic large cell lymphoma (ALCL). This is a rare form of cancer which affects cells of the immune system. MHRA is also aware that it has been widely reported in the Press that the French government will, on Friday 23 December 2011, recommend that all women who have PIP Breast Implants should have them removed as a preventative measure because of health concerns about high rates of implant rupture and cancer. The French regulatory authority (AFSSAPS) have confirmed to MHRA that a statement on the safety of the implants will be made on that day although they have not indicated what advice will be given in relation to patient health and the need to remove these implants. · MHRA have continued to monitor the safety of these breast implants. In 2010 MHRA commissioned testing on the silicone gel filler. Results from this testing demonstrated that there was no evidence of genotoxicity (potential for cancer) or chemical toxicity. · In addition the MHRA was aware of the US FDA’s January 2011 Medical Device Safety Communication entitled “FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma in Women with Breast Implants”. The MHRA informed UK healthcare professionals about the FDA’s communication via a Medical Device Alert (MDA/2011/017) which was issued in February 2011. http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON108774 MHRA has also continued to review available evidence for association of cancers of women with breast implants in consultation with the relevant UK Professional Bodies for breast surgery and surgical oncology and has concluded that there is no evidence to indicate an association with cancer. Additionally the MHRA worked with the Cancer Registry and could find no evidence for an association. The MHRA has not received any reports of women with breast implants of any type in the UK with a diagnosis of ALCL. · Also, the MHRA consulted with experts to discuss whether there was any danger to babies having been breastfed by mothers with these implants. It was concluded that there were no safety issues. · MHRA continues to monitor any associations of all types of breast implants, including PIP, with cancers and any other health implications. We continue to liaise with AFSAPPS and will study the French evidence, discussing these findings with our experts as a matter of priority. · MHRA’s current advice to women with PIP Breast Implants continues to be that should they have any questions about their breasts or implants, that they should seek clinical advice from their implanting surgeon. · There is currently no evidence to support routine removal of PIP Breast Implants. http://www.mhra.gov.uk/NewsCentre/CON137888