Allergan, one of the world’s largest manufacturers of breast implants, has been blocked from selling several popular products in Europe amid growing concerns over a link to a rare form of cancer.
The company has been unable to renew safety certificates, known as CE marks, for two of its textured surfaces — Microcell and Biocell — used in products such as its Natrelle range of breast implants.
Breast implants, like all medical devices, must have CE marks in order to be sold in 33 European countries.
The loss of Allergan’s certificates comes after French regulator Agence Nationale de Sécurité du Médicament (ANSM) last month recommended smooth-shell breast implants be used instead of textured-shell products, citing links between the latter and anaplastic large cell lymphoma (ALCL).
This recommendation was made after ANSM received detailed questions from journalists in France working on the ICIJ’s Implant Files investigation. The yearlong investigation was a collaboration of more than 250 reporters that investigated the harm caused globally by poorly tested medical devices.
Breast implants with certain rough or textured surfaces have been linked to an emerging form of cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Plastic surgeons have identified more than 600 cases of BIA-ALCL worldwide, and the disease occurs at far higher rates among women with textured rather than smooth-surfaced implants.
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 conducting similar evidence-gathering public meetings next year, too.
Responding to the loss of Allergan’s CE marks, the British Association of Aesthetic Plastic Surgeons (BAAPS) on Wednesday said it had advised members not to insert Allergan textured implants from today.
It said the health risks appeared to be small but needed to be better understood. “It is vital that the risks of using textured …implants are fully discussed with all patients prior to surgery so that patients are able to make informed choices,” the BAAPS said.
European CE marks are 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, which — unlike many notified bodies — is partially state-owned.
LNE G-MED was due to renew the CE marks as part of a five-yearly review, but did not. It wants to see further data from Allergan before re-issuing the safety certificate.
Allergan confirmed it had been forced to suspend European sales of products that no longer held a CE mark. It said it would continue to seek a renewed certificate from LNE G-MED, and planed 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.
Meanwhile, on Tuesday ANSM — the French regulator responsible for monitoring the safety of medical devices but not for issuing CE marks — asked Allergan to recall stocks of affected products from all French hospitals.
Allergan said: “Although [the company] 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.”
In advice to women with breast implants in the UK, BAAPS said: “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.”
The loss of CE marks for certain Allergan products does not affect the company’s smooth-surface breast implants.
Other manufacturers also make textured products and have not lost their CE marks.