France’s national agency for the safety of medical devices, the ANSM, has been informed that the medical devices of the Allergan Microcell and Biocell ranges (breast implants and tissue expanders) no longer have the CE marking as of 17 December 2018.
The official statement from the ANSM (translated) is as follows:
The ANSM has recommended, on 21 November 2018, that health professionals preferentially use breast implants with a smooth envelope, pending the opinion of a committee of experts on the use of implants — in particular breast with textured envelopes in cosmetic and reconstructive surgery.
This expert committee, which will meet on 7 and 8 February 2019 as part of a Temporary Specialized Scientific Committee (CSST), is responsible for hearing from patients, health professionals and other stakeholders in order to benefit from global lighting on the use of breast implants.
Following these hearings and the opinion of the expert committee, the ANSM will make a decision on the use of textured-wall breast implants in cosmetic and reconstructive surgery. Those wishing to be auditioned during this CSST had until midnight December 20 to apply. The modalities are available on the ANSM website here.
At this stage, the ANSM has not identified any immediate risk for the health of women carrying the implants concerned. ANSM reminds that women with breast implants should be monitored annually.
To report any adverse event on the reporting portal go to: https://ansm.sante.fr/
As a result the ANSM — the French regulator, has asked Allergan to recall stocks of affected products from all French hospitals. In the UK similarly, no further Allergan textured implants will be used.
What does this mean?
European CE marks are normally provided by accredited certification firms known as notified bodies. Until this week, CE marks for Allergan’s Microcell and Biocell textured surfaces were issued by a French notified body called LNE G-MED. The LNE G-MED was due to renew the CE marks as part of a five-yearly review, but did not do so and stated that it wanted to see further data from Allergan before re-issuing the safety certificate, which normally takes place every 5 years. This was as a result of more recent investigations which have increasingly suggested that breast implants with certain rough or textured surfaces have been linked to an emerging rare form of cancer (lymphoma), breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
However, it must be mentioned that BIA-ALCL is possible with any breast implant, although it appears to have a somewhat stronger link to the more heavily textured shells of the Allergan breast implants.
How common is this cancer?
It is very rare condition. Plastic surgeons around the world have identified just over 600 cases of BIA-ALCL worldwide over the last 10 years, and it appears that the disease occurs at far higher rates among women with textured rather than smooth-surfaced implants.
It is important to note that current research suggests the likelihood of developing this rare condition in the UK is around one in 25,000 breast implants sold. By comparison the general incidence of breast cancer in the UK is one in nine and affects women with and without breast implants equally,
Where does ALCL develop and is it dangerous?
As ALCL is a relative new entity, our understanding of ALCL and its course and effects is continuously evolving. Some researchers suggest it is very uncommon immune related illness as a result of chronic inflammation rather than a cancer, although as explained our understanding is evolving. It seems to form in the scar capsule around the implant and normally begins with pain and swelling in the breast although in some cases it appears to be found by chance and is asymptomatic.
Women who have the implants and capsules removed usually make a full recovery, but if left untreated the disease can spread throughout the body and become life- threatening and it has been associated with 16 deaths in the last 10 years.
Have Allergan textured implants been used in the Karidis Clinic?
Allergan Biocell implants have been used at Karidis clinic from 2009 to approximately 2015. Being one of the biggest providers of breast implants in the UK, Allergan implants have also been used by many other private clinics and surgeons as well as the NHS in the UK.
Since approximately 2015, Mr. Karidis has been using primarily Motiva and Eurosilicone breast implants (both use a different shell type implant to the textured Allergan implants).
Who are Allergan?
Allergan Inc is a leading global multinational bio-pharmaceutical corporation with commercial operations in over 100 countries. Allergan plc (NYSE: AGN), is headquartered in Dublin, Ireland.
Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world and markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
Allergan has also confirmed it had been forced to suspend European sales of products that no longer held a CE mark. It said however, that it would continue to seek a renewed certificate from LNE G-MED, and planned to appeal if denied.
“Allergan takes this situation very seriously and is committed to engaging with all stakeholders to ensure they have the most up to date information,” said Charles Hugh-Jones, Chief Medical Officer at Allergan.
So, if I have Allergan implants, do I have to have them removed or exchanged?
As noted in the ANSM statement, there does not appear to be any immediate risk or even need to have the implants removed. As mentioned in their statement, the ANSM plans to hold a public meeting to review the health risks associated with textured breast implants in February 2019.
The U.S. Food and Drug Administration is also conducting similar evidence-gathering public meetings next year.
We will of course monitor the outcome of these meetings and inform patients accordingly. However as is the advice for all implants, regardless of the texture, women should start to have implant checks regularly from approximately 7 years onwards through either mammograms or ultrasounds to ensure there are no problems.
Of course, should there be any specific concerns or problems or you would just like to discuss the matter, then of course we would be happy to arrange a free follow up consultation for you to see Mr. Karidis to discuss any issues you may have.
What is the situation in the USA with these implants and the Food and Drug Administration who regulated medical devices in America?
These have not been withdrawn in the USA as of the moment and are still in use.
“The FDA is aware of the recent decision by the French Notified Body to not renew the CE mark for Allergan textured breast implants,” the FDA said in a statement, “we have been in contact with French regulatory authorities discuss the issue.”
The FDA is meeting next year to review the safety of all breast implants.
“Breast implants, regardless of surface texture, are associated with a small risk of BIA-ALCL”
the FDA continued in the statement. “There may be multiple factors involved in the development of BIA-ALCL such as patient characteristics, operative procedure history, breast implant characteristics — including surface characteristics and duration the breast implant is in place.”
STATEMENT DATED: 21.12. 2018
We shall be updating this according to any info we should receive ongoing.