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FDA: Rare Cancer Associated with Breast Implants Linked to 9 Deaths

Mar 23, 2017

FDA Receives 359 Reports of Rare Lymphoma Associated with Breast Implants

Cancer Associated with Breast Implants Linked to 9 Deaths

The U.S. Food and Drug Administration (FDA) has issued an update on a rare type of cancer first associated with breast implants. Regulators first noted that anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma, may be linked with breast implants in 2011. In an updated announcement released on Mar. 21, 2017, the agency said that ALCL can occur following breast implants. The FDA has received 359 reports of the cancer in women with breast implants as of Feb. 1, 2017; nine women have died.

Parker Waichman LLP is a national law firm with decades of experience in various types of litigation, including medical device injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a personal injury lawsuit.

When regulators first identified a potential cancer risk associated with breast implants in 2011, there was not enough information to understand the risks. The FDA said in its recent announcement that it has "strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants."

"The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data."

The agency says the cancer appears to occur more frequently in women with textured breast implants, as opposed to smooth implants.

According to the announcement, the FDA received a total of 359 reports of ALCL associated with breast implants since Feb. 1, 2017. Information about implant surface texture was available for 231 reports; 203 were reported as textured while 28 were smooth. In most cases, the reports did not include information about the texture of previous implants.

Information about implant fill types were available in 312 of the 359 reports; 186 reported being filled with silicone gel and 126 reported being filled with saline.

The medical device reports included nine fatalities.

Regulatory Agencies, Professional Groups Learn More about Breast Implant-Associated Cancer

Regulatory Agencies, Professional Groups

According to the FDA, several regulatory agencies and professional organizations addressed BIA-ALCL in 2016. The World Health Organization, for example, determined that women with breast implants can develop BIA-ALCL, a rare T-cell lymphoma. The FDA has since agreed with this designation.

To spread awareness and education about this type of cancer, professional groups such as the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) have released information on diagnosing and treating BIA-ALCL.

Additionally, the FDA is not the only regulatory agency to address the breast implant-associated lymphoma. In Australia, the country's Therapeutic Goods Administration (TGA) estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 in women with breast implants. The regulatory agency said it was aware of 46 cases of BIA-ALCL; three patients died.

In France, the French National Agency for Medicines and Health Products Safety (ANSM) called for additional testing. The agency asked manufacturers of textured breast implants to study how living tissues respond to textured implants; this is known as biocompatibility testing. Companies were asked to report their findings within a year.

The FDA advises patients to become fully informed about the risks and benefits before deciding to undergo breast implant surgery. "Although it is rare, BIA-ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants," the agency said. "Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants."

Patients with breast implants do not need to make changes to their routine medical follow-up, regulators said.

Cases of BIA-ALCL were generally identified through late-stage symptoms, such as pain, lumps, swelling or asymmetry.

Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California's Keck School of Medicine, told The New York Times that with textured implants, tissue grows into the microscopic grooves. Implants with a textured surface are less likely to move.

"When we take these out, you can hear a peeling sound," said Dr. Wong, according to NYT. "Whereas with a smooth implant, it's like Jell-O. You can spin it around. It moves really easily."

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