When Linda Gross’ doctor advised her to have surgery to correct her pelvic organ prolapse (POP), she could not have suspected the complications that would follow. Soon after surgical implantation of the Johnson & Johnson Gynecare Prolift transvaginal surgical mesh, the 46-year-old began to suffer from a number of complications, including pain and swelling. As a result, Gross has undergone 12 surgeries to remove the mesh and correct mesh implant-related complications. The unfortunate truth is that Gross’ plight is not unique.
The Food and Drug Administration (FDA), the federal consumer protection agency that monitors the safety of medical devices, estimates that almost 300,000 transvaginal mesh surgeries were performed last year. While standard complications of the procedure can include pain, the FDA began receiving numerous adverse event reports about mesh devices.
From 2008 to 2010, the federal agency received over 1,500 adverse event reports regarding this class of surgical meshes. These reports, which included complaints of pain, bowel and bladder perforation, additional surgeries, internal bleeding and abscesses, represent a significant increase from previous years. The complaints also call the FDA’s review and approval processes into question.
The various transvaginal surgical meshes, including the Gynecare Prolift, had been approved by the FDA under their 501(k) process. Through this fast track device review process, devices can obtain quick approval if another similar device has already been cleared. For vaginal meshes, the predicate or prototype device was Boston Scientific’s ProteGen sling.
Approved by the FDA in 1996, the synthetic ProteGen sling was recalled in 1999 because of complaints of infections, vaginal wall erosion, bleeding, excruciating pain and even death. Despite its numerous warnings about surgical meshes and transvaginal implantation of these devices, the FDA continued to approve these products. For example, the Bard Avaulta mesh was approved in 2007, and the Gynecare Prolift was approved by the FDA in 2008. Both were approved almost a decade after the ProteGen recall.
Currently, more than 600 lawsuits have been filed against medical device manufacturers for complications related to their vaginal mesh products. Since the 1970s, doctors have been using surgical mesh, originally designed to correct hernias, for POP. These medical devices were designed to alleviate pain and discomfort, but the apparent absence of proper safety testing has transformed these devices into dangers.