Allergan

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).