The U.S. Food & Drug Administration (FDA) has received more than 500,000 adverse event reports involving breast implants over the past 20 years, the vast majority of which were never disclosed to the public.
According to CBS 5 Investigates in Arizona, the FDA’s searchable online database includes just 64,580 reports of breast implant complications made by patients, doctors, or medical device companies.
Yet between 1997 and July 2019, breast implant manufacturers logged an additional 446,084 reports t the FDA’s Alternative Summary Reporting System, or ARS, a secret database that until recently, wasn’t even available to doctors. Those reports detailed a range of debilitating and painful complications, including breast implant ruptures and leaks, device migration and expulsion, and device incompatibility, just to name a few.
Although the FDA ended the ARS program and made the database public in July, the information was contained in zip files and labeled with complex codes. That’s common for government purposes, but not easily searchable for consumers.
CBS 5 Investigates partnered with Device Events, a firm that developed specialized software to convert ARS reports into a more usable form, to determine which medical devices were the most problematic. The top three: dental implants, blood glucose monitors, and breast implants.
The FDA is already reviewing the safety of breast implants.
Just last month, the agency asked Allergan, Inc. to recall Biocell textured breast implants after those devices were linked to a rare type of cancer called anaplastic large cell lymphoma (BIA-ALCL).
BIA-ALCL is not breast cancer, but a slow-growing form of lymphoma that can occur in the scar capsule that develops around breast implants. Symptoms include:
Fortunately, BIA-ALCL is highly treatable when detected early. In most cases, women undergo removal of their breast implants, as well as the surrounding tissue. However, chemo and radiation may also be necessary if the lymphoma has spread beyond the scar capsule.
Roughly 93% of patients who undergo treatment for BIA-ALCL remain cancer-free three years later. When deaths have occurred, diagnosis and treatment were delayed an average of two years after symptoms first appeared.
While BIA-ALCL and other breast implant problems have received a great deal of publicity in recent months, most consumers remain unaware of the ARS reports for other devices, including dental implants and blood glucose monitors.
According to CBS 5 Investigates, the FDA will address dental implants in the near future, when it convenes a meeting to discuss the safety of materials used in medical devices. In addition to dental implants, the agency will be looking at materials used to manufacture silicone breast implants, the Essure birth control device, metal-on-metal hip replacements, and a range of medical products made from animal-derived materials.
The FDA is also working on new guidelines to make blood glucose monitors more reliable.