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FDA Updates Breast Implant Safety Info, Releases Educational Video

Device Safety & Drug Development

August 24, 2020 - This week, the FDA provided an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to as breast implant illness (BII), which some patients report after receiving breast implants. 

Today, the FDA updated the table on the agency's BIA-ALCL webpage to include a total of 733 unique cases and 36 patient deaths globally, which reflect an increase of 160 new cases and 3 deaths since the early-July, 2019 update. Of the 733 cases of BIA-ALCL reported, 620 cases were for Allergan implants, and 47 cases involved implants with an unknown manufacturer. Additionally, 496 cases were reported to have textured implants, and 209 cases did not specify whether the implant had a textured or smooth surface. 

The FDA is also updating information on reports received concerning systemic signs and symptoms referred to as breast implant illness. A new table on the FDA's website summarizes BII reports from the U.S. and worldwide that the FDA received from January 2008 through October 2019. The FDA received nearly 2,500 medical device reports containing symptoms consistent with BII from November 2018 to October 2019. The FDA's information from January 2008 to October 2018 showed 1,080 reports that noted these symptoms. It is believed that more patients and health care providers are reporting these conditions, likely due to increased awareness from press, social media, and the FDA's General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.

The top 10 most common symptoms reported to the FDA's medical device report database for patients with breast implants include fatigue, brain fog, joint pain, anxiety, hair loss, depression, rash, autoimmune diseases, inflammation and/or weight problems. Researchers are studying these symptoms to better understand their potential connection to breast implants. While the FDA doesn't have conclusive evidence that breast implants cause these symptoms, the data collected supports that some patients experience systemic symptoms that may improve or resolve when their breast implants are removed. 

The FDA also announced the approval of the BREAST-Q Reconstruction Module, a self-administered questionnaire that collects pre- and post-surgery information about psychosocial well-being, sexual well-being, physical well-being, and satisfaction with breasts to measure different aspects of a woman's quality of life and happiness with her breast reconstruction surgery. Breast implant manufacturers and researchers have the option to use this tool to collect information from women with implants. FORCE is exploring the option of making this questionnaire available to our constituents. Stay tuned for an update.

Health care professionals and patient are encouraged to report any issues related to breast implants to the FDA's Adverse Event Reporting Program. The FDA monitors these reports and takes the appropriate action to help ensure the safety of medical products like breast implants.

Finally, the FDA released a video on seven things patients should know about breast implants, including risks, complications and information about BIA-ALCL and BII. Note that the video covers implants for augmentation as well as for breast reconstruction; mammograms typically are not recommended for women who have have implant-based reconstruction after a mastectomy. 

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News Briefs

4/29/2024 - Sent the Administrator of the Centers for Medicare & Medicaid Services (CMS) feedback and recommendations on its Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents.

4/3/2024 - Submitted comments to Senator Cassidy and the HELP Committee in response to an RFI regarding oversight of clinical diagnostic tests, known as in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs).

3/15/2024 - Joined the Coalition to Increase Access to Cancer Care (CIACC) in comments to House leadership on efforts to strengthen the Employee Retirement Income Security Act (ERISA) and emphasize the need to pass the Cancer Drug Parity Act.

3/1/2024 - Provided feedback to CMS on the Medicare Advantage Advanced Notice and accompanying Part D Redesign Program provisions aimed at reducing and managing beneficiary out-of-pocket costs in the Medicare Part D program.