FDA Issues Warning on Pelvic Mesh
A pelvic mesh implant may be used during surgery when internal organ support structures have become weakened or stretched so that organs, like the uterus, bladder or bowel, have dropped from their normal positions and bulge or prolapse into the vagina. Many thousands of pelvic mesh implants are surgically placed each year including those manufactured by Gynecare, Bard, Boston Scientific, AMS (American Medical Systems), and Avaulta.
Cellino & Barnes is no longer accepting pelvic/vaginal mesh cases involving American Medical Systems (AMS) products.
There are alternative procedures and techniques that do not involve the use of a pelvic mesh implant. Surgical placement of mesh through the vagina to repair the pelvic organ prolapse, may present an unnecessary risk without offering the benefit of potentially safer options, according to a U.S. Food & Drug Administration.
Dr. William Maisel, Deputy Director and Chief Scientist of the FDA’s Center for Devices and Radiological Health stated, “There are clear risks associated with the transvaginal placement of mesh to treat POP. 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.”
Pelvic Mesh Complications
The most common issues or complications associated with the use of pelvic mesh include:
- mesh becoming exposed or protruding out of the vaginal tissue,
- pain during sexual intercourse,
- organ perforation from surgical tools used in the mesh placement procedure, and
- urinary problems.
Some patients required additional surgery or hospitalization to treat complications or to remove the mesh.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
If you have any questions about pelvic mesh implants, call Cellino & Barnes now at (800) 888-8888 or contact us online.
Cellino & Barnes is no longer accepting new Ethicon pelvic mesh cases.