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FDA Statement

Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

FDA recommends including a boxed warning and other elements in breast implant labeling

For Immediate Release:
Statement From:
Statement Author
Leadership Role
Principal Deputy Commissioner - Office of the Commissioner
Amy Abernethy MD, PhD.
Leadership Role
Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD

Español

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. In a draft guidance issued today, we are providing proposed labeling recommendations to manufacturers of these devices to help ensure women receive and understand information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 The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient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 This draft guidance is an important step in making that happen.

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 The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and health care professionals when breast implants are being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

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 our 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.

The draft guidance also includes a recommendation that breast implant manufacturers include product ingredient information in the device’s labeling in a way that is easy for patients to understand, as we first suggested in a statement released in May. Although this information is currently publicly available online in the FDA’s Summary of Safety and Effectiveness Data for each of the approved breast implants, we’re recommending that product ingredient information be included in the patient labeling in a format that is easy to understand to increase patient access to this information. The FDA believes that improved access to this descriptive information will help better inform patients of the types and quantities of chemicals and heavy metals that are in breast implants. Improved transparency can also improve patient safety.

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 today’s draft guidance, we’re 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. We 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.

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. 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.

This draft guidance is just one of several steps we are taking to help  women considering breast implants, including issuing warning letters to breast implant manufacturers regarding concerns with their required post-approval studies, convening the panel meeting earlier this year to discuss breast implant safety, and, most recently, requesting that one manufacturer recall its textured breast implant devices from the market due to the risk of BIA-ALCL.
 
Our actions reflect the agency’s commitment to advancing policies that enhance the FDA’s oversight of device safety, including device therapies unique to women. We look forward to continuing to engage with patients, manufacturers, the medical community and other stakeholders on these draft recommendations.

The draft guidance is available for public comment. Information on how to submit comments is available in the Federal Register.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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