FDA Proposes Boxed Warning on Breast Implant Risks

Megan Brooks

October 23, 2019

In draft guidance released today, the US Food and Drug Administration (FDA) proposes labeling recommendations to manufacturers of breast implants to make sure women receive and understand information regarding the benefits and risks of breast implants.

The FDA wants a boxed warning to be added to labeling for breast implants to help clearly communicate risks that patients may not know about.

"We have heard from many women that they are not fully informed of the risks when considering breast implants," Amy Abernethy, MD, PhD, the FDA's principal deputy commissioner, and Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement.

The boxed warning should clearly state the following: that breast implants are not lifetime devices; that the chances of developing complications increase the longer a patient has the implant and that 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, such as fatigue or joint pain.

"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 This draft guidance is an important step in making that happen," said Abernethy and Shuren.

Ongoing Concern Prompts FDA Action

The FDA first warned about the risk for BIA-ALCL in 2011. Since then, concern over the issue has intensified. In February 2019, the FDA noted that more cases had been reported, and in March 2019, the agency issued an update and held a 2-day meeting about the risk, as reported by Medscape Medical News.

According to data from the American Society of Plastic Surgeons (ASPS), worldwide, 673 cases of BIA-ALCL had occurred as of January 16, 2019, and there have been 16 disease-related deaths. In a February update, the ASPS said it was aware of 688 cases worldwide, with 17 disease-related deaths in 30 countries.

BIA-ALCL has been linked to textured implants, although there are also case reports implicating smooth implants. In May, the FDA announced that it will allow continued sales of textured breast implants that regulators in other nations have banned or restricted because of concerns over BIA-ALCL. In July, Allergan pulled all textured breast implants in the United States and worldwide because of the concern.

In addition to the boxed warning, the FDA's draft guidance recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure, which can be used to help guide provider-patient discussions.

The draft guidance also revises 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. Currently, approved labeling recommends MRI screenings starting 3 years after implantation and every other year thereafter.

The new draft recommendations propose that patients who do not have symptoms be screened with either ultrasound or MRI 5 to 6 years following implantation and every 2 years thereafter. An MRI is recommended if a patient has symptoms at any time or if ultrasound results are uncertain.

Abernethy and Shuren say these new proposed screening recommendations are based on data showing that rupture rates are "higher five to six years after implantation, [with] 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."

Patient Device Cards

The draft guidance also proposes that breast implant manufacturers include product ingredient information in the device's labeling that is easy for patients to understand, as the FDA first suggested last spring.

"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," said Abernethy and Shuren.

The draft guidance also 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 the serial number of the product. Now, the agency wants manufacturers to include more information on the device card, including the unique device identifier of the product and the boxed warning, and to provide Web links to the patient decision checklist, boxed warning, and labeling for the specific implant so that patients can easily access any updated information on the manufacturer's website.

"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," said Abernethy and Shuren.

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

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