The FDA today issued a draft guidance to propose labeling recommendations to manufacturers of breast implants to ensure women have access to complete information about their benefits and risks.
The recommendations include a boxed warning, a patient decision checklist in the device’s labeling, updated recommendations for patient screening for device rupture and more, according to a statement by the agency.
A public advisory panel meeting held earlier this year by the FDA, along with other efforts to engage with patients and stakeholders, led to the FDA deciding to make the recommendations. The agency said it “heard from many women that they are not fully informed of the risks when considering breast implants.”
In March, the panel concluded that there was not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer. In May, the agency doubled down on that, declaring that it would not ban textured implants.
However, in July, The FDA asked Allergan (NYSE: AGN) to recall its Biocell breast implants after concluding that they are six times as likely as other textured breast implants to cause an uncommon form of lymphoma.
The FDA proposed a boxed warning on the label because it would be noticeable as well as easy to read and understand, communicating risks to the patient. Those risks include the fact that the implants are not lifetime devices, the chances of complications increase with the amount of time a patient has the implant, the possibility of additional surgery and the association with anaplastic large cell lymphoma.
A patient checklist at the end of an informational booklet or brochure was the next FDA recommendation. The agency said the checklist can help guide discussion during surgeon consultations, offering another way to reveal the risks of breast implants.
Other recommendations include rupture screening recommendations for patients with silicone gel-filled implants, including product ingredient information in the labeling and updates to patient device cards that include information about style, size and the product’s serial number.
“Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making health care decisions that fit patients’ needs and lifestyle,” the FDA wrote in the statement. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”