乌鸦传媒

WASHINGTON -- Women with breast implants should have regular monitoring for signs and symptoms of implant-associated anaplastic large-cell lymphoma (BIA-ALCL), according to an .

The recommendation followed an update of the agency's database and understanding of BIA-ALCL and brought the FDA into "concurrence with the World Health Organization (WHO) designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants."

In 2011 the FDA became aware of a possible association between breast implants and subsequent development of ALCL. At the time so few cases of BIA-ALCL existed that the agency could not draw definitive conclusions about the association. Since then, information and understanding about the association increased substantially, including evidence that BIA-ALCL occurs more often in women who have implants with textured, rather than smooth, surfaces.

New information about BIA-ALCL came from medical device reports (MDRs), current medical literature, data from a patient registry established by the American Society of Plastic Surgeons and the Plastic Surgery Foundation (PSF), and product and labeling information provided by implant manufacturers.

Last year the WHO officially recognized BIA-ALCL as a rare form of lymphoma. Also, the PSF and National Comprehensive Cancer Network published physician information about the disease, and several regulatory bodies outside the United States issued statements and shared new information about BIA-ALCL.

As of Feb. 1, 2017, the FDA had 359 MDRs about BIA-ALCL, submitted through the agency's MedWatch safety and adverse event reporting program. The MDRs included 231 reports with information about breast implant surface, and 203 of the cases were associated with implants that had textured surfaces. Additionally, 312 of the 359 MDRs had information about implant content, which was silicone gel in 186 devices and saline in 126.

In the absence of signs and symptoms (lumps, pain, swelling, asymmetry) possibly suggesting BIA-ALCL, prophylactic implant removal is not recommended, the FDA advised healthcare providers. Instead, providers should continue routine care and monitoring for patients with implants.

The agency advised patients to discuss the risks and benefits associated with breast implants, particularly devices with textured surfaces, with a surgeon or primary provider before deciding to undergo an implant procedure. Women who already have implants should continue with routine care and follow-up, as advised by their healthcare providers.

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