Allergan Textured Breast Implant Recall Issued By French Officials Due to ALCL Risks

Amid rising concerns about the , Allergan can no longer sell certain products in Europe, according to French regulatory officials. 

France’s National Agency for the Safety of Medicines and Health Products (L’ANSM) announced an Allergan textured breast implant recall (in French) on December 18, after a deadline passed for the manufacturer to renew its license to sell the devices in the European Union.

The license, known as the CE marking, expired on Sunday. While Allergan had applied for a renewal, France blocked the move, requesting additional information on the safety of the textured implants, which have been linked to reports of a rare type of cancer in the tissue surrounding the breast, known as anaplastic large cell lymphoma (ALCL). The recall was issued after Allergan said it could not provide the requested information in time.

The loss of the marking means that the devices cannot be sold in Europe, and those devices still on hospital shelves are being recalled.

French health officials had already planned hearings on the risk of breast implant-associated ALCL for February 7 and 8, during which they were likely to discuss a ban on the implants due to the cancer links.

Cases of the breast implant lymphoma have been tracked in France since 2011, with health officials recently indicating that there have been at least 53 cases of BIA-ALCL, the vast majority of which were linked to textured implants.

In November, French regulators recommended doctors stay away from textured breast implants when performing cosmetic and reconstructive breast surgery.

Breast Implant Cancer Concerns In the U.S.

On January 26, 2011, in the U.S.  the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.

The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.

Product liability lawyers in the U.S. are now reviewing other potential breast implant cancer lawsuits for women diagnosed with anaplastic large cell lymphoma (ALCL) in recent years, alleging that manufacturers knew or should have known about the risk, yet withheld warnings from consumers and the medical community.