FDA adds Black Box Warnings on all Breast Implants

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October 28, 2021 – Yesterday the FDA has proposed adding “Black Box” warnings on all breast implant products, its strongest consumer warning.  The warning is to increase awareness in women who may be considering having breast implants.  According the American Society of Plastic Surgeons there were 193,073 breast augmentation surgeries in the U.S. a drop of 33% from 2019.

This comes on the heels of the FDA being pressured from women you say they weren’t adequately warned about the possible side effects of chronic fatigue, joint pain and a type of cancer called anaplastic large-cell lymphoma (BIA-ALCL).

The FDA has now issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. 

Second, the FDA approved new labeling for all legally marketed breast implants that includes:

  • Boxed warning. 
  • Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device.  The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
  • Updated silicone gel-filled breast implant rupture screening recommendations. 
  • Device description with a list of specific materials in the device.  
  • Patient device card.

The FDA expects manufacturers to post the updated device labeling to their websites within the next 30 days.

FDA Press Release statement:

“Protecting patients’ health when they are treated with a medical device is our most important priority,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “

In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery. As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”

Sales and Distribution of Breast Implants are now Restricted.

The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants.

  • Allergan Natrelle Silicone Gel-Filled Breast Implants 
  • IDEAL Implant Structured Breast Implants
  • Mentor MemoryShape Silicone-Filled Breast Implants
  • Mentor MemoryGel Silicone-Filled Breast Implants 
  • Mentor Saline-Filled and Spectrum Breast Implants
  • Allergan Natrelle Saline Filled Breast Implants 
  • Sientra OPUS Silicone Gel Breast Implants

In 2019 Law Firms sued Textured Breast Implant Maker Allergan PLC.

On July 25, 2019 Allergan Plc issued a statement on Wednesday it was recalling all of its Biocell textured breast implants and tissue expanders across markets, citing concerns over a rare form of cancer, after the FDA asked the manufacturer to pull the products.

The FDA has issued a warning to women of a potential rare form of cancer associated with textured breast implants.  The warning comes after the FDA received 359 medical device reports (MDRs) of cancer linked to the implants and 9 deaths.

The deaths were not from breast cancer but a very rare form known as breast implant-associated anaplastic large cell lymphoma, a form of non-Hodgkin’s lymphoma, (BIA-ALCL). The basis of those lawsuits was failure to warn and that the company knew of the risks of their textured implants before they recalled the products.

Sources:

https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-report-2020.pdf

https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants

https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants