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Federal health regulators working to increase awareness about the growing number of lymphoma cases linked to breast implants, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
On February 6, the FDA sent a letter to health care providers, updating them on the status of the agency’s investigation into the link between breast implants and a rare type of cancer that may develop in the surrounding tissue.
There are now at least 457 confirmed breast implant lymphoma cases worldwide, with 246 new cases identified since September 30, 2017. That number includes at least nine deaths.
The letter seeks to further increase awareness in the medical community about the risk that women may develop lymphoma following breast augmentation surgery. While prior studies have suggested that large surface area, textured implants, the agency indicates that the medical community should be aware that the increased risk is associated with all types of breast implants, “regardless of filling or texture.”
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Dr. Binita Ashar, of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
The FDA actually received a total of 660 medical device reports involving cases of BIA-ALCL as of September 30, 2018. However, Ashar says that an in-depth analysis of that data revealed that only 457 of the cases are unique.
In addition, Ashar notes that while the FDA received 246 reports in a year’s time, that number does not represent the number of new cases over the last year. It represents a mix of new cases, health care professionals becoming aware of old cases that have been redefined and, in some cases, the same incident is reported by manufacturers, doctors and perhaps even patients.
The letter to healthcare providers calls for those who regularly treat patients with breast implants to learn about BIA-ALCL.
“We want to ensure that all providers who treat patients with breast implants have information regarding identification, diagnosis and treatment,” Ashar wrote. “Patients are more likely to seek routine care from primary care physicians, gynecologists and others besides their treating plastic surgeon. By providing information to health care providers, we believe more providers will be empowered with information to assist patients who may have BIA-ALCL.”
Breast Implant Cancer Concerns
On January 26, 2011, the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.
The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, 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.
Next month, the FDA is holding a meeting of its General and Plastic Surgery Devices Panel to discuss the benefits and risks of breast implants.
The FDA encourages healthcare professionals and patients to report suspected cases of BIA-ALCL to the agency’s MedWatch adverse event reporting program.
In addition, product liability lawyers in the U.S. are now reviewing other potential breast implant lymphoma lawsuits for women diagnosed with ALCL in recent years, alleging that manufacturers knew or should have known about the risk, yet withheld warnings from consumers and the medical community.