Just two months after the United States Food and Drug Administration said that it knew of no “definitive evidence demonstrating that textured breast implants cause” a rare form of cancer, as AVN.com reported, the FDA did an about-face and requested a recall of the implants.
The manufacturer, Allergan, on Wednesday complied with the FDA request, issuing a global recall of Biocell breast implants, a “textured” type of implant that is designed to move around internally in the breast to a lesser degree than smooth implants. The textured implants are less common, and account for only about five percent of all breast implants in the United States, according to a CNN report.
Nonetheless, FDA official Dr. Binita Ashar said in a press conference, “hundreds of thousands of women have these implants.”
The specific brand names of the recalled implants, according to CNN, are “Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.”
The textured implants have already been recalled in 38 countries, prior to the FDA request, due to their link to a rare form of cancer that affects the immune system, known as “anaplastic large cell lymphoma,” according to NBC News, or Breast Implant-Associated Anaplastic Large Cell Lymphoma, BIA-ALCL.
It was only in May that the FDA declined to order a recall of the textured implants, saying that instead it would “take steps to improve the information available to women and health care professionals about the risks of breast implants.”
According to FDA statistics released in Wednesday, there have been 573 cases of BIA-ALCL worldwide, with 481 cases directly linked to the textured implants. There have been 33 deaths of women from the rare form of lymphoma, according to NBC News.
Not all women who contracted BIA-ALCL were recipients of the textured implants, however.
“This recall will reduce that risk [of cancer] but it won’t eliminate it,” said Diana Zuckerman, president of the National Center for Health Research, quoted by NBC News.
In addition to the recall, Allergan said that the implants will no longer be distributed or sold in areas where they are now available, according to a New York Post report.
Photo By U.S. FDA / Wikimedia Commons Public Domain
