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WASHINGTON -- The number of cases of a rare type of lymphoma linked to breast implants has surpassed 400, according to .

As of Sept. 30, 2017, the FDA had received 414 medical device reports (MDRs) of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a 15% increase since agency's previous report on the issue in March 2017. The MDRs included nine patients who died.

Not all reports included complete information, but from the information available, the FDA determined that:

• 242 involved implants with textured surfaces and 30 with smooth surfaces
• 234 implants were filled with silicone gel and 179 with saline
• In about half the cases, the BIA-ALCL diagnosis occurred 7-8 years after implantation

As part of the update, the FDA reviewed reported cases of BIA-ALCL in the medical literature and found that the estimated lifetime risk of developing BIA-ALCL for a women with textured breast implants rages from 1 in 3,817 to 1 in 30,000. However, the FDA emphasized that it is not changing its recommendations on use of breast implants.

"We've been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants," Binita Ashar, MD, of the FDA Center for Devices and Radiological Health, said in a statement. "We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue."

Investigators at the FDA identified a possible association between breast implants and ALCL in 2011 and has collected, updated, and reported information about the association since that time. In 2016 the World Health Organization recognized BIA-ALCL as a category of malignancy, and the National Comprehensive Cancer Network has published information about the condition. Regulatory agencies in Australia and France have collected data on BIA-ALCL and reported the information.

BIA-ALCL usually arises in and around scar tissue and fluid near the implant but can spread systemically. Precise risk estimates are difficult to determine because of a lack of information about the number of patients in the U.S. and worldwide who have received breast implants.

The has information about BIA-ALCL for patients and healthcare professionals. The agency recommends against any changes in routine care and follow-up for individuals with breast implants.

"Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about risks and benefits," the FDA statement indicated.

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