FDA Proposes New Labeling Requirements for Breast Implants

On October 23, 2019, the United States Food and Drug Administration issued a statement outlining a draft guidance geared toward ensuring patients have complete information about the benefits and risks of breast implants. It offers numerous labeling recommendations for implant manufacturers, including that they incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture and add product ingredient information that is easy to understand. The statement reads, in part:

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. 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 The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and health care professionals when breast implants are being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.

First, we’re 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. We 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Additionally, the draft guidance recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure.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. An example of a checklist that incorporates these recommendations is provided in the draft guidance and encourages patients to ask their surgeon about the surgeon’s experience, education, training and credentials. 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.

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 draft today 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.

For more information, visit www.fda.gov.

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