The FDA released a statement on its continued efforts to protect women’s health and enhance safety information available to patients considering breast implants.
In draft guidance issued on Oct. 24, the FDA proposed labeling recommendations to manufacturers of breast implants to help ensure women receive and understand information regarding the benefits and risks of breast implants. The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture, and more.
"We’ve heard loud and clear from the public advisory panel meeting we held earlier this year and from the information we’ve gathered from other ongoing efforts to engage with patients and stakeholders that there is a distinct opportunity to do more to protect women who are considering breast implants. We believe women should have thoughtful and balanced discussions with their health care providers about both the benefits and risks of breast implants based on clear and current information. This draft guidance is an important step in making that happen," according to the statment issued by Principal Deputy Commissioner - Office of the Commissioner Amy Abernethy MD, PhD and Director - CDRH Offices: Office of the Center Director Jeffrey E. Shuren MD, JD.
The FDA guidance says that the boxed warning should help communicate risks that patients may not know, including that breast implants are not lifetime devices; the chances of developing complications increase the longer a patient has the implant and additional surgery may be required to address the complications; and that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms.
The draft guidance also includes a recommendation that manufacturers include a patient decision checklist to help guide discussion during a patient’s consultation with a surgeon. A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIA-ALCL and risk of implant rupture, among others.
"We believe the information contained in the example of the patient decision checklist can contribute to a patient’s understanding of both the benefits and risks of breast implants," the statement says.
Earlier this year in July, just days after surgeons from the British Association of Aesthetic Plastic Surgeons (BAAPS) and elsewhere called for warnings on silicone-filled breast implants due to risk of “breast implant illness,” Allergan issued a voluntary worldwide recall of Biocell textured breast implants and tissue expanders due to concerns of BIA-ALCL.
Following the recall, Modern Aesthetics spoke to Bryan G. Forley, MD about what is known about the reported cases of BIA-ALCL. Watch the interview now: modernaesthetics.com/videos/breast-implants-assessing-the-risk-for-bia-alcl