Allergan, one of the world’s largest manufacturers of breast implants, has been banned from selling two of its textured surfaces in Europe.
The halt came from the National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du médicament et des produits de santé or ANSM), who did not renew the CE Mark health-and-safety certification.
Some researchers have raised concerns about a cancer risk connected to certain textured implants. Breast implants, like all medical devices, must have CE marks in order to be sold in 33 European countries.
The CE withdrawal affects two of Allergan’s textured surfaces — Microcell and Biocell — used in products such as its Natrelle range of breast implants.
ANSM encourages patients with the implants to undergo regular checks with their doctors for a blood cancer called anaplastic large cell lymphoma (ALCL), which occurs more often in women with textured breast implants. Plastic surgeons have identified more than 600 cases worldwide. ALCL is treatable.
Allergan disagrees with the recall reasoning but continues to work with authorities to clarify the issue.
“Although Allergan disagrees with ANSM’s request, the Company is fully cooperating with the authority. Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request and this action is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.”
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader and operates in more than 100 countries.
They focus on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan stated it looks forward to participating in the scientific forum that ANSM has scheduled for early February, “where the full set of data and scientific evidence for textured breast implants can be presented and thoroughly discussed by all stakeholders.”
“Patient safety and product quality are Allergan’s highest priorities. 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.
- Read the full statement here
The company said its breast implants are safe and it’s not recommending surgical removal, which can cause health problems.
What the surgeon’s in the UK said
The British Association of Aesthetic Plastic Surgeons (BAAPS) on Wednesday said it had advised members not to insert Allergan textured implants from today.
Read the statement by the BAAPS
“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.” as stated in the association’s official website.
The BAASPS also noted that 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.”
For the European entity, the health risks appeared to be small but needed to be better understood: “It is vital to fully discuss with all patients about the possible risks prior to surgery so that patients are able to make informed choices.”
What the FDA says
According to the United States Food and Drug Administration, BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants.
“Individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL,” noted the FDA.
The FDA clears out that BIA-ALCL is not breast cancer rather a type of non-Hodgkin’s lymphoma (cancer of the immune system). “In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body.”
A textured surface keeps the implant in place in the body. But a recent analysis of 115 research articles on lymphoma connected to breast implants raised concerns about the possibility that textured versions may be connected to higher cancer risk.
About 1 in 30,000 women with breast plants get lymphoma annually.
Precise risks are difficult to determine due to the lack of information about how many patients have received breast implants in the US and worldwide.
Who is the ANSM
The National Agency for the Safety of Medicines and Health Products is the French government agency with jurisdiction over pharmaceuticals, biological products, medical devices, and cosmetics.
It was created by the Act of 1 July 1998, works under the Ministry of Health and has the authority to monitor and regulate health products. Breast implants are within the medical devices category.
On May 1st, 2012, the ANSM superseded the AFSSAPS (l’Agence française de sécurité sanitaire du médicament et des produits de santé) and received a broader authority to monitor and evaluate health products, as well as a greater budget.
The ANSM also actively participates in standardizing and harmonizing regulation and practices on the European market.
- Related: Medical Device Regulations in Europe