There’s been a critical development surrounding the safety of vaginal mesh implants. According to a letter filed yesterday with U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, who is overseeing the litigation, Johnson & Johnson’s Ethicon will stop selling four of its vaginal mesh implants. This comes after 600 women filed suit, alleging the products caused serious internal injuries. A representative of Ethicon said sales of the devices will cease throughout the world.
According to the letter, Ethicon has asked the FDA for 120 days to end sales so it can “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” and “Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time.”
Complications associated with transvaginal mesh include infection, painful sexual intercourse, urinary problems, and overall discomfort and bleeding, all caused by the mesh eroding through tissue or the skim contracting too tightly around the device.
The FDA estimates that about 100,000 women a year with pelvic organ prolapsed are treated with the plastic mesh. The irony is that the medical condition can most often be treated without mesh and thereby avoiding the increased risked associated with the medical device.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel, chief scientist of the FDA division that oversees medical devices, in a TVM press release. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”