In October 2008, the FDA sent warnings to physicians that a number of serious and painful complications associated with Transvaginal Mesh had been identified in hundreds of women. These women had received the mesh in the treatment of pelvic organ prolapse, stress urinary incontinence, and a number of other problems.
These problems are leading to transvaginal mesh lawsuits because of how they compromise quality of life. While the FDA issued their first warning in 2008 with another in 2009, their warning stated that more than 1,000 women had experienced problems with the mesh between 2005 and 2007. A total of nine manufacturers were involved. Those manufacturers were Johnson & Johnson, American Medical Systems, Caldera, Boston Scientific, Mentor, Gynecare, Ethicon, Sofradim, and C.R. Bard, Inc.
Transvaginal Mesh Injury
According to the FDA, the complications that have come about after some women have received Transvaginal Mesh include:
- The mesh eroding through the vagina
- Organ perforation
- Pain during sex
- Urinary problems
There have been at least three cases in which women died from Transvaginal Mesh complications. Further complications include bowl and bladder perforation during the surgery.
As of July 2011, the FDA stated that over 2,800 new reports of Transvaginal Mesh complications had been recorded. These procedures had taken place between January 2008 and December 2010. Studies showed that approximately 10% of the women had experienced mesh erosion within a year of having the surgery. For over half of those who experienced erosion, they had to have an additional surgery to remove the mesh. If the complication was severe enough, multiple surgeries were required.
In the end, the FDA stated that they were not clear on whether the repair of pelvic organ prolapse with Transvaginal Mesh was better than non-mesh procedures. As a matter of fact, the agency stated that the mesh procedure may expose the patients to a higher risk of complications.
Even if the mesh is not defective, surgeon error can cause complications. These complications can include perforation of organs, blood vessels, or the vaginal wall with the surgical tools used in the procedure. When the FDA alerted physicians of Transvaginal Mesh complications in 2008, they also recommended that those surgeons performing surgeries to implant Transvaginal Mesh to undergo specialized training.
Transvaginal Mesh Side Effects
If you or a loved one has suffered from the complications that can be caused by receiving Transvaginal Mesh, you may be able to receive compensation from the mesh manufacturer. Our Transvaginal Mesh injury attorneys are offering each woman suspecting she is experiencing complications after surgery, a free case evaluation. We urge you to contact us at 1-800-732-3070 or fill out the contact form on this page so that we can help you protect your legal rights.