FDA Calls for the Removal of Breast Implants Linked to Rare Form of Cancer
The FDA called for this removal after new information showed that the Biocell breast implants with a textured surface manufactured by Allergan accounted for a disproportionate number of rare lymphoma cancer cases.
What you need to know
On July 24, 2019, the U.S. Food and Drug Agency reversed its recent position by calling for the removal of certain breast implants linked to cancer. The cancer is a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (ALCL). Until recently, many doctors had never heard of the disease. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.
Before the recall, the agency noted that the cancer cases appeared to be more common among women using breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not made. The FDA called for this removal after new information showed that the Biocell breast implants with a textured surface manufactured by Allergan accounted for a disproportionate number of these rare lymphoma cancer cases. The FDA first reported a link between implants and ALCL in 2011, and information was added to the products’ labeling. But the added warnings were deeply embedded in a dense list of complications.
The textured Biocell surface was designed to prevent slippage and to minimize scar tissue. These implants account for only about 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface. This recall does not affect Allergan’s smooth implants or a different Allergan textured implant sold under the Microcell brand. Because the cancer is so rare, the agency is not yet recommending that women with these types of implants remove them. But they say women should check with their doctor if they have symptoms, which include pain and swelling. The FDA’s move follows similar recalls in France, Australia and Canada.
A look at the numbers
Roughly 400,000 U.S. women get breast implants each year and the FDA estimates that hundreds of thousands of U.S. women have the Biocell implants. The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of ALCL worldwide have been linked to Allergan implants. Regulators estimate that the risk of the disease is six times higher with Allergan’s implants than other textured implants sold in the U.S.
However, there is no firm agreement on the exact frequency of this cancer. Published estimates range from 1 in 3,000 patients to 1 in 30,000 patients. Researchers from Australia’s Therapeutic Goods Administration published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.
What exactly causes the ALCL is also still largely unknown. According to Dr. Mark Clemens of Houston’s MD Anderson Cancer Center, the Biocell’s surface produces a large amount of particles that shed into the body—more than other textured implants. “But what key factor is most important, we don’t know at this time,” said Clemens, a plastic surgeon who has published extensively on the disease.
We're here to help
Although rare, complications from ALCL can be devastating. Main Street Law Firm is here to help individuals who have suffered adverse side effects, including ALCL, from Allergan's textured breast implants. We believe Allergan ought to be held accountable for failing to adequately warn consumers of these risks. Contact us today for a free, no-obligation review of your case.