Transvaginal mesh implants are surgical implants used to treat or prevent pelvic organ prolapse (POP), which can occur in women after childbirth or surgery. POP causes the womb to fall into the vaginal area, and can also lead to the bladder and bowels slipping out of place and putting pressure on the vagina, causing considerable pain and discomfort, as well as urinary incontinence in some cases. The implants may also be used to treat incontinence.
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.
Serious complications since 2008, when the FDA issued a warning about transvaginal mesh placement, have been seen in more than 1,000 reports on devices from nine different manufacturers.
In October 2008, the FDA issued notified clinicians and patients of the risks of urogynecological use of surgical mesh and provided recommendations on how to mitigate risks and counsel patients.
After the notice, the FDA continued to monitor the use of surgical mesh. A search of the FDA’s Manufacturer and User Device Experience (MAUDE) database, between January 2008 and December 2010, identified 2,874 urogynecological surgical mesh reports noting instances of injury, death and malfunctions. Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse repairs, and another 1,371 were associated with stress urinary incontinence repairs.
Today, more than 100,000 transvaginal mesh cases have been filed on behalf of victims.
The FDA also reviewed data to learn more about the safety and effectiveness of using surgical mesh. The FDA determined that serious adverse events more common than it had reported in 2008. It also reported that transvaginally placed meshes in pelvic prolapse repairs do not conclusively improve clinical outcomes over traditional non-mesh repair.
The FDA is providing this update to advise the public and the medical community of complications related to transvaginal POP repair with mesh.
In many cases, implant problems have required multiple surgeries to remove the vaginal mesh. Even after surgery, women may be left with permanent and disfiguring injuries. Other complications from the implants include infections, erosion of the mesh, recurrences of prolapse, urinary problems, blood vessel and organ perforation and pain during sexual intercourse.
The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report that usage at a later date.
Ennis & Ennis, P.A. is investigating claims for all vaginal mesh implants, including the major manufacturers:
If you have had a transvaginal mesh sling implanted and experienced serious side effects, call the lawyers at Ennis & Ennis to find out if you meet the criteria for a vaginal mesh lawsuit. With offices in Washington D.C. and throughout Florida, we are ready to help victims across the United States. Call our offices or set up a free case evaluation through this website to speak with one of our female attorneys about this sensitive matter.