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In response to growing concerns about the risk of cancer and other health problems linked to breast implants, federal regulators are recommending manufacturers add new “boxed” label warnings and patient checklists to ensure women consider both the benefits and risks before undergoing surgery.
The FDA published a draft guidance (PDF) in the Federal Register on October 24, outlining recommended label warnings for saline and silicone gel-filled breast implants.
The guidance is a recommendation, and not a requirement for manufacturers. However, FDA guidance heavily implies what the agency deems is acceptable behavior and practices.The guidance is only in draft mode currently, and the FDA is taking public comment for the next 60 days before finalizing it.
“We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves,” agency officials said in a press release. “Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information. The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and health care professionals when breast implants are being considered.”
The boxed warning would include information about the risk of a rare type of cancer linked to the devices, which is commonly referred to as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), as well as indicate breast implants are not lifetime devices; meaning they often have to be removed and replaced, and the chance of complications increases the longer a patient has the implants in place.
The FDA is also recommending manufacturers include a patient decision checklist to ensure patients are aware of all of the relevant breast implant risks, and indicates patients should go through new breast implant rupture screening practices, which would involve an MRI or ultrasound five or six years after receiving a silicone breast implant; then undergoing additional screenings every two years after that or when presenting with symptoms of a possible rupture.
Breast Implant Recall
The draft guidance comes about three months after the FDA announced that the manufacturer had agreed to issue a worldwide breast implant recall for certain Allergan products that feature a microtextured design.
The FDA indicates there are at least 573 known cases of BIA-ALCL worldwide, including 33 deaths. Of those, 481 have been linked to Allergan breast implants. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.
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.
Another study, published in October 2017, 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.
Despite the recall, the FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
A number of women nationwide are now pursuing class action lawsuits to secure compensation for the defective and dangerous implants, and individual breast implant ALCL lawsuits are being filed against the manufacturer by women diagnosed with this rare cancer after receiving one of the recalled devices.