The U.S. Food & Drug Administration (FDA) wants medical device manufacturers to provide prospective patients with comprehensive information on cancer and other possible complications prior to breast implant surgery.
According to draft guidance posted to the Federal Registry today, the agency will recommend that breast implant manufacturers include a boxed warning on their product labels and create a checklist patients can review before making a final decision to undergo breast augmentation or reconstruction. Among other things, they would be informed that breast implants don’t last a lifetime and that the potential for complications increases the longer the devices remain in place.
The FDA will also recommend that heavy metals, chemicals, and other ingredients be listed on the labeling in an easy-to-understand format, and suggested all recipients be provided a card with detailed information and breast implant warnings, including the exact type of devices they have.
Finally, the agency plans to recommend that all breast implant recipients undergo imaging scans five years after the initial surgery to check for ruptures, and then every two years after that.
Once finalized, the FDA’s guidance would be strictly voluntary. The precise labeling would be left in the hands of breast implant manufacturers, who can either implement the agency’s recommendations or “choose other methods” to communicate the information. Doctors would be tasked with ensuring prospective patients are aware of risks and benefits prior to surgery.
More than 400,000 women received silicone breast implants last year, either for breast augmentation or reconstruction after mastectomy. In recent years, however, thousands of recipients have reported serious complications following surgery, including severe muscle and joint pain, weakness, cognitive difficulties, and fatigue. This collection of debilitating symptoms has been termed “breast implant illness” by many patients and their advocates.
Devices with a textured surface have also been linked to Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL, a rare cancer that forms in the scar capsule around the devices. When detected early, most cases of BIA-ALCL can be treated successfully by removing breast implants and surrounding tissue. However, chemo and radiation may also be necessary if the cancer has spread beyond the scar capsule.
Earlier this year, Allergan, Inc. recalled Biocell textured breast implants and tissue extenders after the FDA determined those devices were most frequently associated with reports of BIA-ALCL.
The company is now facing several federal class action lawsuits over the breast implant recall. Earlier this month, plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate their claims before a single federal judge, preferably in the U.S. District Court, District of Tennessee, or the U.S. District Court, Middle District of California.