Published on October 23, 2020
FDA Announces Guidance for Patients Considering Reconstructive Breast Implants
The U.S. Food and Drug Administration (FDA) has issued its final guidance on labeling recommendations for breast implant manufacturers, including a black box warning, the agency’s most stringent warning for drugs and medical devices.
The governmental organization also suggests manufacturers provide women who are considering breast reconstruction with a decision checklist to ensure patients receive and understand information about the benefits and risks of implants.
The guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, recommends manufacturers include information about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma, and breast implant illness (BII), a term used to describe a set of symptoms such as fatigue, brain fog, memory loss, muscle or joint pain and rash that some patients attribute to their implants.
Risks and Complications of Breast Implants
“As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a press release. “It is important that patients discuss the risks and benefits of breast implants with their health care provider, and we hope that these labeling recommendations will help in facilitating these discussions.”
In August 2020, the FDA published new data on the harmful side effects associated with breast implants, reporting there were 160 cases of BIA-ALCL and three deaths from July 7, 2019, to January 5, 2020, bringing the total to 733 cases and 36 deaths.
The agency stated reports of BII totaled nearly 2,500 from November 2018 to October 2019, an increase of 1,080 from January 2008 to October 2018. The agency attributed the increase to a growing awareness of BII driven by the news coverage, social media, and the FDA’s General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.
What Patients Need to Know about Breast Implants after Cancer
The final guidance is based on a 2019 draft and was created as part of the agency’s efforts to help patients and healthcare professionals understand the risks of breast implants.
The recommendations are intended to enhance, but not replace, discussions between doctors and patients about the benefits and risks of breast implants that relate to individual patients, the agency said.
According to the guidance, the boxed warning should inform patients that:
- Breast implants are not considered lifetime devices
- The chances of developing complications increase over time
- Some complications will require more surgery
- Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
- BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
- Breast implants have been associated with systemic (BII) symptoms
The patient decision checklist should include:
- Situations in which the device should not be used or implanted
- Considerations for a successful breast implant candidate
- Risks of undergoing breast implant surgery
- Importance of appropriate physician education, training and experience
- Risk of BIA-ALCL
- Risk of systemic (BII) symptoms
- Discussion of options other than breast implants, as appropriate
The guidance also includes recommendations on rupture screening for silicone gel-filled implants, a materials/device description in the product labeling of breast implants filled with saline or silicone gel, and a patient device card with the type of implants, a serial or lot number and a toll-free phone number for the manufacturer.
Breast Cancer Survivor Has Implants Removed, Supports FDA Guidelines
Roxane Vermeland, a breast cancer survivor who was treated for BIA-ALCL after receiving implants, said in a statement to CURE® that she was pleased to hear about the FDA’s decision. Vermeland, of Yorkville, Illinois, noticed lumps just months after reconstructive surgery following a double mastectomy, she told the Chicago Tribune. Her implants were removed after she became septic and almost died. Vermeland testified before the FDA at the March 2019 meeting.
“This is great news,” Vermeland told CURE®. “We have been advocating hard for this, as women need to know the risks of implants upfront so they can make an informed decision. The black-box warning alone is a major accomplishment for us which will truly make women think about the decision to put implants into their bodies.”
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