Pharmaceutical giant Allergan has withdrawn its most popular breast implants from the market in Europe, possibly due to concerns about a rare form of lymphoma. In December 2018, France’s National Agency for the Safety of Medicines & Health Products (ANSM) ordered that the company no longer manufacture or sell its Microcell and Biocell implants, which have significant surface texturing. The agency did not specifically mention cancer in its statement, which goes on to assert that “the ANSM has not identified any immediate risk for the health of women carrying the implants concerned.”1
The ANSM ordered the recall of the textured implants after their European safety certification expired. The certifying agency, GMED, said it was suspending the Conformité Européene (CE) mark for Allergan’s Microcell and Biocell products, specifically, pending committee review of additional data, which Allergan has not yet provided. The ruling does not affect sales of the implants in the United States, but textured implants are used much less frequently in the US than they are in Europe. Allergan’s smooth implants remain on the market worldwide, unaffected by the decision.
Several retrospective studies have linked textured implants to a type of peripheral T-cell lymphoma called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.2-5 The first documented case of BIA-ALCL arose in 1997, and since then, the FDA has recorded a total of 414 medical device reports of the disease, including the death of 9 individuals.6
New results from France strengthen the connection with textured breast implants.4 In a poster presentation at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego, California, researchers from Hôpital Henri Mondor, Créteil, France, shared data on BIA-ALCL collected by The Lymphoma Study Association (LYSA).
LYSA began tracking BIA-ALCL cases in 2016, and since then, 50 cases have been recorded. The team at Henri Mondor analyzed 39 of those, comparing the reason for implantation, the type of implant, the number of times the implant was replaced, and the outcomes. Information about implant type was available for 31 patients. All 31 had had at least 1 textured implant; 26 of these had at least 1 Biocell implant. More than half of the patients had their implants replaced at least once before receiving a diagnosis of BIA-ALCL.
The median delay between first implant was 11.9 years, a figure that is concordant with findings from previous studies. Chronic inflammation from low-level infection may be triggering the uncontrolled growth of T cells, says Kevin Rakszawski, MD, chief fellow of hematology/oncology at Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania. In 2017, Dr Rakszawski coauthored a review paper on BIA-ALCL, which encompassed 93 cases from the literature and 2 additional cases seen by Dr Rakszawski himself.3 Every case for which the implant type was known involved textured implants at some point; some patients had had both kinds, but no patient had a history of only smooth implants.
The textured surface is intended to reduce certain complications, such as capsular contracture. This happens when the scar tissue around the implant tightens and the implant become hard, which may cause discomfort and can change the shape of the breast.