FDA - Call to Action on Breast Implant Safety

FDA - Call to Action on Breast Implant Safety

April 11, 2019
Petition to
Center for Devices and Radiological Health and 7 others
Signatures: 11,529Next Goal: 15,000
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Why this petition matters

Started by Breast Implant Victim Advocacy & Multiple Breast Implant Illness Support Groups

Patients harmed by breast implants started a petition on change.org over a year ago asking the FDA for a public meeting to discuss breast implant safety.  On March 25 and 26th of 2019, the FDA granted us our request. Over 70 harmed patients and caregivers were in attendance to give their testimonies. They made heartfelt pleas for the FDA to do more.

Breast Implant Victim Advocacy presented a Call to Action to the FDA in response to the two-day meeting. We are summarizing our points below, which are also supported by the National Center for Health Research and multiple online support groups. Patients affected by breast implant illness and BIA-ALCL played a part in creating these points. We now present a petition to the FDA and CDRH to uphold these actions.

We ask the FDA to uphold the following:

•1) Provide breast augmentation and reconstruction patients with a mandatory, short, and understandable patient booklet and patient/surgeon checklist (checklist should be similar to Essure) to be written by a committee of harmed breast implant patients and plastic surgeons with FDA monitoring. This should include a black box warning about BIA-ALCL and describe the reports of breast implant illness.

•2) The FDA should enforce requirements of pre-market and post-market large, long-term studies of thousands of women with breast implants and adopt the strategies of Ideal Implants to ensure adequate follow-up. FDA should require smaller studies aimed at determining the best diagnostic and treatment protocols for BIA-ALCL. Failure to comply with study requirements should result in a moratorium on inadequately studied implants.

•3) We urge the FDA to ban Biocell textured implants and expanders and place a moratorium on other textured implants and expanders until studies are completed to determine safety. The FDA should require implant companies to pay for physicians and medical centers to notify patients with textured implants about the risk and symptoms of BIA-ALCL.

•4) The FDA needs to require that breast implant manufacturers provide a list of all ingredients used in the production of each model of breast implants, and include this information on their websites for public view.

•5) The FDA should require adverse event reporting for each event, rather than summary data. Companies' failure to report adverse event reports in a timely manner should result in warning letters to physicians about the companies' failure. This should include compliance in reporting cases of BIA-ALCL.

•6) The FDA should provide the opportunity for harmed patient representation on the Breast Implant Advisory Team.

Thousands on thousands of patients are being harmed. Adverse event reports for breast implants exceed the number reported for any other medical devices in the US.

Advocates would like to thank the FDA for the increased patient engagement opportunities. We look forward to the continual collaboration with both the FDA and plastic surgery organizations. We need to work together to find common ground and move forward with actions that protect patients.

We urge the FDA to move forward with the above actions. Our patients deserve better. Failed regulation and flawed studies need to be addressed. It's time to move forward.

Support now
Signatures: 11,529Next Goal: 15,000
Support now

Decision Makers

  • Food and Drug Administration
  • Center for Devices and Radiological Health
  • Binita S. Ashar, MDFDA Director, Division of Surgical Services
  • Jeffrey ShurenFDA
  • David KrauseFDA