Silicone breast implants, a medical product that suffered a major safety warning and ban in the U.S., made a surprising comeback when the U.S. Food and Drug Administration (FDA) reversed its decision in 2006 to ban silicone breast implants, and restored the medical device to the marketplace. This occurred after intense pressure from manufacturers even though safer, smooth, saline-filled implants posed less of a threat to women’s health.
Based on information currently available—including newly-submitted data—analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers who market in the U.S.
BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system) and is not breast cancer. BIA-ALCL is often found in scar tissue and fluid near the implant, but in some cases, it can spread throughout the body.
Although most cases of BIA-ALCL are associated with the use of textured breast implants—particularly macro-textured implants such as those made by Allergan—a continuing assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants, is now underway.
Lobbying by leading manufacturers, Allergan and Mentor, led to the decision by regulators who chose to ignore frequent ruptures and leaks and other ailments reported by silicone and textured breast implant patients. Women were misled and told these concerns were in the past. A recent worldwide investigation by the International Consortium of Investigative Journalists (ICIJ), however, has helped us see the truth. It’s known that breast implants are linked to autoimmune disorders and now it is been discovered that Allergan’s Natrelle BIOCELL textured Implants are linked to a rare form of cancer that is claiming women’s lives called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
WHAT YOU NEED TO KNOW
The FDA issued a voluntary global recall of Natrelle BIOCELL Textured Breast Implants and Tissue Expanders on July 24, 2019 to protect individuals from the increased risk of a rare type of cancer: breast implant-associated anaplastic large cell lymphoma, associated with Allergan BIOCELL textured breast implants.
The FDA decided against taking action on these implants as recently as two months before the recall. In March of 2019, regulators spent two days hearing testimony from women who had developed lymphoma or other symptoms following breast implant surgery. The agency decided in May of 2019 that there wasn’t enough evidence to warrant a recall. Only when a new batch of data surfaced in July of 2019, showing a significant increase in both the number of cancer cases and deaths, did the FDA take the unusual step of asking Allergan to issue a recall.
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) showing worldwide cases of breast implant-associated anaplastic large cell lymphoma related deaths linked to these devices. Allergan agreed and is voluntarily removing these products from the global market.
The FDA’s analysis was attributed to a reported new worldwide total of 573 breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 were reported to have Allergan breast implants at the time of diagnosis.
SPECIFIC PRODUCTS SUBJECT TO RECALL
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. Following are the textured styles:
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. The following are the textured styles:
Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as: