The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled.
The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and breast implants.
Today’s request is the first on the subject since 2019 when the agency issued statements in response to harsh public criticism of its efforts to regulate the medical device industry. The 2018 Netflix documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the FDA and the medtech industry over patient injuries attributed to faulty devices.
The Bleeding Edge focused on the Bayer (ETR:BAYN) Essure sterilization device. The company announced in August 2020 that it had settled approximately 90% of U.S. claims involving women alleging injuries related to Essure. Essure users had claimed a number of problems related to the device, including perforation, pain, bleeding, weight gain, nickel sensitivity, depression, unwanted pregnancy and hysterectomy, according to the company. The Implant Files looked into a wider variety of devices that the FDA has cleared through its 510(k) process, spurring the agency to reevaluate and update it.
Metal-on-metal implants have been among the most notable medical device industry failures of the early 21st century. The hip implants were supposed to be stronger and more durable, but they instead were plagued by higher failure rates and potential exposure to toxins from metal particles released by friction.
Some breast implants have been associated with certain types of cancer and “breast implant illness” or BII. BII is not cancer, nor is it a term often found in medical literature. But it is frequently used by patients and healthcare providers when reporting adverse events related to breast implants, the agency has said.
Now the agency is asking for input on labeling that would help patients make better-informed decisions on which medical devices are appropriate for them and to help identify whether an immunologic/hypersensitivity response to a material in a device was the cause of adverse health consequences experienced by the patient in whom the device was used.
You can read the FDA’s discussion paper on materials labeling here.