During her tenure at the FDA, Tomes worked on the agency’s adverse event reporting program. She can search the entire FDA medical device adverse events data since 1996. For instance, Tomes recently investigated Essure complaints and found 303 reports referencing these fetal “death like” terms—reported as injuries rather than deaths-- and provided the information to Congressman Mike Fitzpatrick with the goal to remove Essure from the market.
Turning her attention to transvaginal mesh, Tomes looked at the FDA’s MAUDE database that houses reports of adverse events involving medical devices. She believes that “all TVM devices are dangerous but only one type [American Medical Systems] is getting any attention”. Along with more than 25,000 attorney reports and 23,641 doctor reports, there are over 1,000 ‘User Facility’ (hospital) reports. “And distributors also represent a much higher number than usual,” adds Tomes. FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices.
The FDA data also shows 126,349 reports of mesh adverse events and 49 recalls. The manufacturers involved are Johnson & Johnson (42,890 complaints), Bard, Medventure Technology and Boston Scientific.
Most worrisome is the number of mesh deaths. Like her findings with Essure, Tomes notes 1,299 death reports associated with “mesh or sling”, which also includes Gore Dualmesh that is used for hernia repair. “This is likely a low number because often deaths are reported as injuries and malfunctions,” she points out. From the information provided, it is unclear how many deaths are related to transvaginal mesh used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
But the FDA reports that between 2008 and 2010, seven deaths were associated with POP repairs. According to Medscape, an FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3,979 reports of injury, death, and malfunction.
READ MORE TRANSVAGINAL MESH LEGAL NEWS
Four years later, almost 60,000 transvaginal mesh lawsuits had been filed.
Device Events was founded by Madris Tomes, July 2015. Through her previous work experience with the FDA and several consulting organizations, the need for clean, intelligible data presented itself. Device Events is focused on the medical device domain and provider space emphasizing the use of various technologies to enable intelligent searching of large data sets.