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FDA proposes black box warning and patient checklist for breast implants

Breast implant Silicone 9884The U.S. Food and Drug Administration issued draft guidance Wednesday on proposed labeling for breast implants. The guidelines recommend that manufacturers include a black box warning and patient decision checklist in the device’s labeling and update recommendations for device rupture.

A black box warning is the strictest warning put in the labeling of prescription drugs or devices by the FDA to call attention to serious or life-threatening risks.

The FDA said it heard from a public advisory panel meeting and from information it’s gathered from patients and stakeholders that more needs to be done to protect women who are considering breast implants.

“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the FDA said in a statement. “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 FDA said.

Diana Zuckerman, president of the National Center for Health Research, said her organization thanks the FDA for proposing a black box warning and a patient check list that provides specific, understandable information about the risks of breast implants. 

“The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” Zuckerman said.

However, she added, “The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make.”

Zuckerman said her organization will  keep working closely with the FDA, patients, and plastic surgeons to make the goal of better information for those considering having breast implant surgery a reality.

The FDA recommendations are voluntary when adopted and are considered guidance to the industry.

In 2018, 313,735 women had breast implants, up 4 percent from 2017, according to the American Society of Plastic Surgeons. About three-fourth of the implants were cosmetic, and most of the rest were for reconstruction after breast surgery.

In 2018, 29,236 women had breast implants removed.

The FDA is proposing:

A boxed warning be included in labeling for breast implants. It recommends that manufacturers identify risks, including that: (1) breast implants aren’t lifetime devices; (2) the chances of developing complications increase the longer patients have the implants and additional surgery may be required; (3) implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma or BIA-ALCL; and (4) implants may be associated with symptoms, such as fatigue or joint pain.

Manufacturers include a patient decision checklist in an informational booklet to guide the consultation with a surgeon. Patients can acknowledge individual risks of breast implants, such as risks from the surgery, the risk of BIA-ALCL, and risk of implant rupture. An example checklist in the draft guidance also encourages patients to ask their surgeon about his or her experience, education, training, and credentials.

A revision for the rupture screening recommendations for patients with silicone gel-filled breast implants. The FDA’s current labeling recommends MRI screenings for patients beginning three years after implantation and every other year after that. The proposal recommends patients without symptoms be screened using either ultrasound or MRI at five to six years following implantation and every two years after that. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.

Manufacturers include product ingredient information in the device’s labeling in a way that’s easy for patients to understand. Improved access to this information will help inform patients of the types and quantities of chemicals and heavy metals that are in breast implants.

Updates to patient device cards. In addition to information about the style, size, and serial number of the implant, the draft guidance is proposing adding the unique device identifier of the implant, the boxed warning, and web links to the patient decision checklist, boxed warning, and labeling for the implant so that patients can find updated information on the manufacturer’s website.

After a public comment period and the guidance is finalized, manufacturers can choose to follow the guidance or select other methods for labeling their devices.

Earlier FDA action on breast implants included issuing warning letters to breast implant manufacturers on concerns with their post-approval studies and requesting that one manufacturer recall its textured breast implant devices from the market due to the risk of BIA-ALCL.

You can comment on the draft guidance on this Federal Register page.


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