Cancer Warnings Added to Textured Breast Implants, Rather Than Requiring a Recall

Rather than recalling certain textured breast implants linked to an increased risk of cancer, federal regulators have decided to add label warnings, advising consumers and the medical community that women may develop a rare form of lymphoma in the tissue surrounding the implant.

On May 2, FDA Principal Deputy Commissioner, Dr. Amy Abernethy, and Dr. Jeff Shuren, the FDA’s Center for Devices and Radiological Health, issued a statement announcing new efforts to address concerns linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL in January 2011.

In 2017, the agency issued an updated statement about emerging information on the breast implant lymphoma problems, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.

In the statement, the FDA officials indicate the agency will improve the information available to doctors and women about the risks of breast implants. They also want to include warnings about potential health problems which have become known as breast implant illnesses. Both of these would be done through new label warnings on all breast implants.

The FDA also indicates it is changing how breast implant manufacturers file medical device reports.

“In an effort to promote greater public transparency, the FDA has ended all summary reporting of breast implant medical device reports and has notified breast implant manufacturers of this decision,” the announcement indicates. “Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE (Manufacturer and User Facility Device Experience).”

The agency indicates this is part of a larger effort to end summary reporting for all medical devices. The FDA expects to complete that effort in coming weeks.

In addition, the FDA is also partnering with two breast implant registries to collect real world data on patients in order to get better information on the health risks, noting that the incident reports are not a reliable census of the problem.

However, the FDA also explained that it is not issuing a textured breast implant recall, which has been done in some countries like France and Canada. The agency officials note that in the markets where textured breast implants have been recalled, they make up as high as 80% of the market. However, in 2018, textured breast implants were less than 10% of the market in the U.S., and the specific type of macrotextured implant most associated with BIA-ALCL only accounted for five percent of the market in the U.S.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act,” the agency officials wrote. “The FDA believes regulatory action must be based on scientific data. While the majority of women who developed BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis.”

Breast Implant Cancer Risks

In 2017, the agency issued an updated statement about emerging information on the breast implant lymphoma problems, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

Earlier this year, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.