FDA warns over breast implant cancer risk after nine deaths confirmed
pharmafile | February 8, 2019 | News story | Medical Communications, Research and Development | Cancer, FDA, breast implants, pharma
The FDA has warned against the link between breast implants and anaplastic large cell lymphoma, noting that at least nine patients have died as a result of this association since 2010.
There have been 457 unique cases breast implant-associated anaplastic large cell lymphoma confirmed by the US regulator out of 660 reports. Crucially, the disease linked to breast implants is not breast cancer but a form of non-Hodgkin’s lymphoma. The link was first identified in 2011, but a lack of data and certainty in reported cases in the US and beyond meant that the FDA was restricted in responding to the potential threat in a robust manner.
So far, it has been noted that research indicates the associated threat is greater in implants with textured surfaces as opposed to flat, but many reports of the link did not mention surface texture. In December last year, Allergan had some of its popular breast implant products blocked in Europe due to these same concerns over its potential to cause cancer.
“I know there are many choices of breast implants available to patients, including the size, implant fill and surface texture,” remarked Binita Ashar, Head of the Center for Devices and Radiological Health at the Food and Drug Administration. “We want to provide patients with the most up-to-date information about the variety of breast implants available so that patients and providers can have thorough and thoughtful discussions weighing the benefits and risks of different products.”
“For patients, we know the information regarding breast implants can be overwhelming, which is why we are committed to continuing our efforts to provide up-to-date publicly available resources to help understand the known benefits and risks of implants,” he continued.
“We encourage patients to review our website and read specific device labeling, including patient labeling information, for any product they may consider implanting. 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 products.”
The FDA is continuing to encourage medical professionals to continue to report cases of BIA-ALCL.
Matt Fellows
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