Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds

Regulatory NewsRegulatory News | 07 February 2019 |  By 

The US Food and Drug Administration (FDA) sent a letter to health care providers on Wednesday to raise awareness on additional cases of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).

The letter addresses the last update on medical device reports (MDRs)—otherwise known as adverse event reports—submitted to FDA’s Center for Devices and Radiological Health (CDRH) regarding BIA-ALCL. The September 2018 update reported on a total of 660 MDRs of BIA-ALCL, up from the 414 of such MDRs that CDRH had received as of September 2017. The update amounts to 246 new cases since 2017.

As part of the agency’s additional data analysis, duplicates were removed to identify 457 unique MDRs for BIA-ALCL. These include nine patient deaths that were found to be likely attributable to BIA-ALCL.

Binita Ashar, a general surgeon and director of the Division of Surgical Devices at CDRH, explained that “the number of unique cases is lower than the total number of reports because the FDA’s medical device reporting system allows patients, providers and manufacturers to each file their own reports even if it’s about the same case, which can lead to duplicative reports of BIA-ALCL.”

Ashar argued that the spike in reported cases of BIA-ALCL had been anticipated given the agency’s ongoing efforts to increase awareness among health care providers and patients around the risk associated with breast implants. Yet challenges with analyzing the reported data remain. These relate to a lack of information in submitted MDRs, such as patient history on breast implant replacements.

The agency’s analysis of reported BIA-ALCL cases “is better when there is a wide-range of information provided concerning the breast implant texture and implant fill, and other helpful details like a patient’s age, how long a patient has been implanted, and time from implantation to diagnosis,” Ashar noted.

From radiologists and pathologists to plastic and cosmetic surgeons, the letter informed a wide range of health care providers about the known risk of breast implants over the growing BIA-ALCL cases.

“FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant,” wrote CDRH chief medical officer William Maisel. “We want all health care providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants.”

Other challenges regarding data on BIA-ALCL cases relate to the variation in incidence rates estimated in current literature as well as the variation in the types of breast implants approved in different countries.

Maisel pointed out that the currently “estimated incidence rates range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000.” Ashar also noted that the agency’s “counterparts in different countries are taking certain actions or may be reporting different information about breast implant safety than the FDA. The different devices approved in each country, availability of products, variation in market share, extent of medical device adverse event reporting, and availability of information regarding the total number of implants sold differs from country to country. This makes it difficult for the regulatory bodies of different countries to compare data and determine risk rates on a global scale.”


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Tags: adverse, letter, MDR

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