FDA Notes Link Between Breast Implants and Lymphoma

The US Food and Drug Administration (FDA) recently updated its information regarding a correlation between breast implants and the development of a specific type of cancer. Now, several lawsuits have already been filed against various implant manufacturers, and more such cases are likely to arise.

Breast Implants and Lymphoma

In 2011, the FDA began gathering data on the association between breast implants and the development of specific type of cancer, known as anaplastic large cell lymphoma (ALCL).

In 2016, the World Health Organization specifically designated breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, as a condition in which ALCL occurs following the insertion of breast implants. The WHO noted that the cancer appears to be more common when the breast implants used have a textured surface instead of a smooth surface.

Anaplastic large-cell lymphoma is not a form of breast cancer. Rather, it is a rare type of non-Hodgkin lymphoma, a cancer that originates in the lymphatic system. The Lymphoma Research Foundation estimates that only about one percent of all non-Hodgkin lymphoma cases are ALCL.

The FDA is continuing to gather information about the link between breast implants and ALCL, noting that lack of information on breast implant sales and ALCL reporting has made it more difficult to build a clear link or to form theories about why the textured implants seem more likely to cause this particular cancer.

Class Action Lawsuits Involving the Link Between Implants and Cancer

As of September 30, 2018, the FDA had received 457 unique reports of BIA-ALCL, including 9 reports that described patients death secondary to lymphoma. At least 200 of the reports noted that the patient in question had received textured rather than smooth breast implants.

In March 2018, one patient filed a lawsuit against Allergan Inc., the makers of the patient’s implants, after the patient received a BIA-ALCL diagnosis. The patient alleged that she had had her Allergan Natrelle Silicone breast implants for less than two years before receiving the diagnosis. Treatment included surgery to remove the implants, chemotherapy and additional surgeries, including the removal of affected lymph nodes.

The complaint in the Allergan case argued that Allergan’s “breast implants lacked proper warnings as to the dangers associated with their use” and that the company failed to report post-marketing study results to the FDA in a timely manner.

Allergan is also facing a class action lawsuit from its investors after allegations that Allergan had misrepresented the status of its textured breast implants to investors in Europe. According to the allegations, Allergan continued to claim that its textured implants were legal to sell in Europe, despite the fact that a European oversight body had declined to renew the implants’ safety certification and French authorities issued a recall of the implants.

A similar BIA-ALCL based lawsuit, filed in April 2018 against Mentor Worldwide, focuses on the Mentor MemoryGel SILTEX implants. In the Mentor case, the plaintiff alleges that she had the implants for about 8 years before she was diagnosed with BIA-ALCL. The plaintiff in that case underwent surgery to remove the implants and six lymph nodes, as well as chemotherapy.

Expert Involvement in Breast Implant Cancer Cases

While the FDA continues to gather information linking breast implants to ALCL, the agency admits that the information it currently has is insufficient to build a detailed case explaining the causal link between textured implants and this rare form of cancer. While the FDA and WHO agree that a link seems to exist, neither agency has currently stated that they understand the mechanisms involved.

Consequently, evidence to build this link will likely be collected as various lawsuits progress – and the contributions of expert witnesses will have a profound effect on how that evidence is collected, interpreted, and presented.

Likely experts in these cases will include oncologists and other researchers with experience studying ALCL and similar lymphomas. They may also include plastic surgeons, as well as researchers who study the effects of implants on the human body.

Since ALCL is a relatively rare form of cancer, and since the causal link between breast implants and ALCL remains a site of investigation and inquiry, attorneys engaged in BIA-ALCL-related product liability cases may benefit from consulting experts in related fields, whether or not the expert is asked to testify at trial. Evaluating the research and sources used by opposing experts may also be essential to build a strong case.