FDA Warns Against Johnson and Johnson Product The FDA issued a warning this past July for transvaginal surgeries to treat pelvic organ prolapse. Complications such as mesh erosion, pain, infection, bleeding, pain during sex, organ perforation, and urinary problems were experienced by patients.
Mesh May Not Be Best OptionPelvic organ prolapse (POP) is a condition where the pelvic organs can come out of the vaginal opening. More than one organ can prolapse or protrude at a time.
|Device name:||Transvaginal mesh|
|Manufacturer:||Johnson & Johnson
American Medical Systems
|Approved uses:||Surgically implanted vaginally to improve pelvic organ prolapse – a condition when a woman’s uterus, bladder, or rectum slips out of place.|
|Related topics:||Composix Kugel Hernia Mesh Patch, Medical Devices|
|Common Misspellings:||trans vaginal mesh, transvaginal mesh, vaginal mesh, vaginal mesh repair, transvaginal surgical mesh, trans vaginal surgical mesh, vagina mesh|
Mesh Migration –Vaginal mesh complication where the mesh moves to another part of the pelvic region, resulting in bleeding and/or infection.
See our Vaginal Mesh Glossary
Vaginal Mesh Complications
Vaginal Mesh is a device that is surgically implanted through the abdomen or vagina to improve pelvic organ prolapse, a condition that occurs when a woman’s bladder, uterus or rectum fall out of place. In 2011, the FDA issued an updated warning stating vaginal mesh shows little evidence of improving POP and that the risks outweigh the potential benefits.
A study conducted in 2005 by the Journal of Obstetrics & Gynecology found more than 15 percent of women experienced vaginal mesh erosion where the mesh erodes into the vagina, which causes pain, pelvic pain, and infections. Other potential problems include dyspareunia (pain with sexual relations), fistulas and recurrence of prolapsed organs or contraction of the mesh, which leads to vaginal shrinkage.
Some women have undergone additional surgery to remove or repair the mesh, however it is difficult to remove fully, causing life-long pain and suffering. Manufacturers report that more than 100,000 women underwent surgery for prolapse, 75,000 of which were vaginally inserted.
Unlike FDA drug approvals, many medical devices are cleared without clinical trial data requirements. If you have experienced pain, infections, bladder or urinary problems, or other serious side effects due to vaginal mesh surgery, contact a LegalView attorney for a FREE case consultation.