In 2019, the FDA recommended its most serious warning label for BIOCELL textured breast implants that academic studies linked to a type of cancer known as BIA-ALCL. Two years on from the warning, and a decade after this was discovered, the issue is still unsolved.
Healthtech Founder Joan Melendez believes this risk could be mitigated using inventory management technology and automatic entries.
“There are storerooms and warehouses full of medical devices and products such as breast implants, and without using tracking and inventory tech, there’s no easy and fast way to communicate, check, remove or track harmful products and implants,” said Joan.
Breast implants have historically not been tracked as seriously as other medical devices, unique in their category as both a medical implant and an appearance-enhancing cosmetic treatment.
Allergan warning notices and a lack of regulation
Almost a year after the initial recall notice, the FDA issued a warning letter to Allergan due to their inadequate post-approval studies. Poor recruitment and follow-ups with their post-approval study group of subjects violated the FDA’s requirements.
In the release, Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health said: “The FDA imposes post-approval requirements because they are an important tool for ensuring the safety and effectiveness of the medical devices we regulate.”
A disconnect between the FDA, manufacturers, and patients further aggravates the problem.
“The FDA regulates manufacturers. Manufacturers sell to plastic surgeons. Once the implant is in, the patient is given a card with their unique tracking number. Lose that card and game over.” Joan explained. “Now there are thousands of women that may have lost that card but have the recalled implants. They’ll be kept in the dark until something goes wrong.”
Hidden and ineffective recall notice methods put patients at risk
Recall notices from the FDA are outdated compared to modern alternatives, slowing down and rendering their communication methods ineffective.
The FDA’s medical device database relies on hand-typed entries from several groups of people to track adverse events, leading to inaccurate or missing data. A notice on the FDA website notes that recall notices can be done using “telegrams, mailgrams, or first-class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: “medical device recall [or correction]”.
Worse than this, many breast implant adverse events were hidden from the public. Manufacturers are able to report adverse events using ”alternative summary reporting”, which allows thousands of adverse events to be hidden from the public, or even other healthcare workers. Over 1 million incidents have been put into alternative summary reporting since 2016.
Medical device malfunctions, including breast implants, are also allowed to be reported quarterly rather than individually, preventing the reporting of death or injury. The Manufacturer and User Facility Device Experience database, available to the public, should allow the general public to search for injuries, deaths, or malfunctions related to any medical device.
But with manual entries unregulated, information is often missing, and device names and manufacturers are misspelled or inconsistent.
When entering “ALLERGAN” as the Brand Name, patient entries vary, including “ALLERGAN BREAST IMPLANT”, “ALLERGAN TEXTURED IMPLANT”, “ALLERGAN TEXTURED BREAST IMPLANTS”, and misspelled version including “ALLERGEN TEXTURED IMPLANTS”, and patient comments including “I learned a couple of months ago that implants have been recalled. I do not understand test range and unit [sic].”
UDIs, and the future of breast implant tracking
The Unique Device Identifier, introduced by the FDA to help track medical devices, isn’t help when it comes to breast implants. The number is stamped on the packaging rather than the implant itself. And when adverse event reporters are submitted, the UDI is often omitted.
Dedicated databases such as the National Breast Implant Registry may support the tracking of breast implants. Without automatic tracking and communication, and patient education, systems like this will likely remain incomplete.
“Healthtech systems can make the most of UDIs and ensure that the manufacturer, surgeon, and patient are all connected. There is no risk of missing or inaccurate information, and the onus is taken off of the patient as the systems will report issues in real-time.” Joan explained.