Allergan PLC has pulled its breast implants from the European market after a regulatory approval expired, while medical experts plan to consider evidence that suggests the products cause a rare form of cancer.
The French National Agency for the Safety of Medicines & Health Products, known by its French acronym ANSM, said on Dec. 18 that the products involved were Allergan's Microcell and Biocell implants. The agency said it has not identified any immediate risk for women using the products.
The Botox maker said its withdrawal from Europe follows a recall request by ANSM after the regulator suspended the CE safety approval for Microcell and Biocell on Dec. 18. The company added that it stands behind the benefit/risk profile of its products and that the ANSM recall is not based on any new scientific evidence.
Dublin-based Allergan will participate in a scientific forum ANSM scheduled in February to discuss the full set of scientific data with stakeholders, the company said in a Dec. 19 news release.
A project by the International Consortium of Investigative Journalists, or ICIJ, and reported by the U.K.'s The Guardian in November found wide-ranging safety concerns in the breast implant market, with over 1,200 serious incidents linked to the products in the U.K. since 2015. Of the 1,200 reports, 57 involved anaplastic large cell lymphoma, a blood cancer affecting the immune system, the investigation found.
Data from plastic surgeons suggest that at least 615 cases of the rare cancer have been linked to the implants, including 16 deaths, The Guardian said in a separate Dec. 19 report.
The British Association of Aesthetic Plastic Surgeons, or BAAPS, said the risk of developing the cancer in the U.K. is one in 24,000 breast implants sold, while the general incidence of breast cancer in the U.K. is one in nine in women with or without breast implants. BAAPS advised its members not to use Allergan's implants in the same statement.
BAAPS President Paul Harris said the suspension of the CE mark for Allergan's implants is more of a precautionary step while regulators examine the link between the products and the rare cancer.
Meanwhile, a large study in the U.S. examining the country's largest implant producers, Allergan and Mentor Worldwide LLC, also suggested links between the silicone breast implants and the development of certain rare illnesses, such as Sjögren's syndrome and scleroderma, The Guardian reported.
Sjögren's syndrome is a disease where a patient's immune system mistakenly attacks the glands that produce tears and saliva, while scleroderma is a disorder where a person's skin and connective tissues tighten and harden.
Allergan responded to the report by saying the safety profile of the implants is supported by pre-clinical device testing, over 10 years of U.S. and European clinical use, and a number of peer-reviewed and published studies.
Allergan woes could slow augmentation procedures in U.S.
A Dec. 19 analyst note from Stifel said the timing of the CE mark suspension does not appear to be specifically related to the lymphoma concerns. Instead, Stifel said Allergan's regulatory approval expired, and when the company attempted to renew it, the ANSM requested more safety information that Allergan was unable to provide immediately. Stifel said textured breast implants, which stick to the body's tissue and stay in position over time, have been linked to lymphoma, while smooth implants do not appear to have such a concern.
Allergan's products, specifically, have a more aggressive form of texturing and a higher level of lymphoma cases have been linked to the products. Stifel estimated that 85% of breast implant procedures in international markets involve textured implants.
The U.S. Food and Drug Administration identified a possible link between lymphoma and breast implants in 2011, Stifel said. The agency strengthened its understanding of the link in August 2017.
As for the market impact, Stifel said that plastic surgeons in the U.S. could turn to other manufacturers such as Sientra Inc. in light of the CE mark suspension by France. Sientra could, therefore, be in a position to "accelerate market share gains," according to Stifel. The Santa Barbara, Calif.-based medical aesthetics maker does not offer its products on the international market and is unlikely to do so for 15 or more months, but Stifel said Allergan's issues could nevertheless open the door for Sientra.
Overall, the news could slow U.S. implant procedures, but Stifel noted that the rate of augmentations did not appear to change following the U.S. FDA's 2017 announcement.