The U.S. Food and Drug Administration is taking another significant step in protecting women’s health by helping to ensure patients have complete information about 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The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient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.
FDA has 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. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information. The agency appreciates this important feedback and, in this draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and healthcare professionals when breast implants are being considered.
First FDA is proposing that a boxed warning be included in labeling for breast implants. A boxed warning generally will be noticeable and easy to read and understand. The boxed warning should help communicate risks that patients may not know. They recommend that manufacturers identify certain risks in the boxed warning, 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 (like fatigue or joint pain). Calling out this information in a boxed warning will help ensure patients see this important information.
Additionally, the draft guidance recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure. A patient decision checklist can be used 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.
Another recommendation described in the draft guidance focuses on revising the rupture screening recommendations for patients with silicone gel-filled breast implants. Previously, the FDA recommended that labeling include the method(s) and frequency of screening for rupture, and current approved labeling recommends magnetic resonance imaging (MRI) screenings for patients beginning three years following implantation and every other year thereafter. The new recommendations issued in the draft guidance propose that patients without symptoms be screened using either ultrasound or MRI at five to six years following implantation and then every two years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.
These new proposed screening recommendations are based on data showing rupture rates are higher five to six years after implantation, recommendations from the American College of Radiology, recommendations from the FDA panel meeting earlier this year, data suggesting that ultrasound is an effective screening method for asymptomatic patients and FDA’s awareness of poor patient compliance with the existing MRI recommendations. By proposing updates to the recommendations based on current science and other information, the FDA hopes to make it easier for patients to comply with these new recommendations.
Finally, the draft guidance includes updates to previous recommendations concerning patient device cards. In 2006, the FDA recommended that manufacturers provide patients, following surgery, with a device card that includes information about style, size and serial number of the product. In the current draft guidance, FDA is proposing that manufacturers include more information on the device card, including the unique device identifier of the product, the boxed warning, and also provide web links to the patient decision checklist, boxed warning and labeling for the specific implant so that patients may easily access any updated information on the manufacturer’s website. They believe including this information in an easy to access format will serve as an additional way to ensure women have as much information as possible to make informed decisions.
