On March 25th, the U.S. Food and Drug Administration (FDA) began a two-day Public Advisory Committee meeting to discuss the safety of breast implants and their potential links to life-threatening health problems.
Held in Silver Spring, Maryland, the panel follows warning letters issued by the FDA on March 19th to two breast implant manufacturers for noncompliance with premarket approval requirements.
As noted in their press announcement, “every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants.”
These letters of warning, however, are only beginning for action combatting the discovered health problems that women with breast implant complications have been reporting for decades.
While women impacted by the lack of transparency take a stand, the FDA has yet to add stronger warnings and regulations surrounding breast implants.
In fact, the International Consortium of Investigative Journalists reported that the federal agency has received more than 350,000 incident reports involving breast implants since 2009, according to a chart shared by the agency.
“That’s more than 20 times as many reports as the agency had posted on its public-facing database as of late last year,” according to the ICIJ.
Finally, the FDA has opened dialogue to plastic surgeons, women’s and cancer advocacy groups, and the general public concerning a wide range of breast-implant-related concerns.
The agenda stated that their panel of federal medical advisors would address the following topics:
- Breast-Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- Systemic symptoms in patients receiving breast implants
- The use of registries for breast implant surveillance
- Magnetic resonance imaging screening for silent rupture of silicone gel-filled breast implants
- The use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
- The use of real-world data and patient perspectives in regulatory decision making
- Best practices for informed consent discussions between patients and clinicians.
Some panel members called for a ban on certain implants while others, like committee chair Frank R. Lewis Jr., MD who emphasized that linking breast implants to their seemingly vast multitude of consequent symptoms would be challenging without a standardized measure of the common BII symptoms.
As quoted in the MDedge summary of the meeting, Lewis added, “that may be exceedingly difficult, with as many as a hundred reported symptoms.”
Diana Zuckerman, PhD, president of the National Center for Health Research, pushed for regulatory measures despite these obstacles. She went on to report 449 women who had approached the Center in 2018 and 2019 for help obtaining health insurance coverage for medically-necessary removal of their breast implants.
While no consensus for affirmative action was reached, panel members, plastic surgeons, advocacy groups, and attendees who endured the negative health effects of FDA-approved breast implants all recognized the importance of expanding required, routine surveillance on breast implants and increasing transparent labeling of the risks.
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