Potential Vaginal Mesh Complications
It is believed that over 200,000 women receive mesh implants each year, however as the number of implants has continued to rise, so has the number of complications reported by recipients. In fact, some estimates place the number of women who have suffered complications from their vaginal mesh implant as high as ten percent. Pelvic organ prolapse occurs when one or more pelvic organs shifts downward, in some cases intruding into the vaginal canal. As many as 25% of all women in the United States suffer some degree of pelvic organ prolapse and as the Baby Boomers continue to age it is believed the number of pelvic organ prolapse surgeries will continue to rise.
Vaginal mesh was likely used in a large percentage of the women who have undergone pelvic organ prolapse surgery due to a history of chronic pelvic pain, painful intercourse, incontinence and a feeling of pressure in the pelvic region. Surgical mesh was approved for use in pelvic organ prolapse surgery in 2002, and by 2008 the FDA was issuing their first public health alert which detailed the potentially serious complications associated with transvaginal placement of the mesh during surgical procedures for pelvic organ prolapse or stress urinary incontinence. Adverse reports from women who have undergone pelvic organ prolapse surgery using mesh include:
- Mesh erosion
- Infection
- Excessive bleeding
- Urinary problems
- Chronic pain
- Pain during intercourse
- Perforation of other organs during the surgical procedure
The problems which occur from surgical mesh implants can significantly lessen a woman’s enjoyment of life due to physical and emotional complications.
FDA Approval of Vaginal Mesh
In 2011, the FDA ruled—after hundreds of adverse reports from women—that vaginal mesh complications were not rare and that vaginal mesh showed no significant benefits over more traditional treatments for pelvic organ prolapse and stress urinary incontinence. Johnson & Johnson gained approval for their mesh device based on the precursor known as the Kugel patch, even though the Kugel had problems of its own. Approval of medical devices based on the assertion they are substantially equivalent to a device which has received prior approval from the FDA is, some believe, a significant flaw in the FDA approval process.
Prior to the FDA’s public health alert regarding vaginal mesh in 2008, the American College of Obstetricians and Gynecologists warned physicians to consider the vaginal mesh procedure “experimental,” noting that all patients who consented to the procedure should be fully informed. Despite the problems with vaginal mesh, the FDA continues to defend the approval system in place, although last February a bill was introduced into Congress which was meant to stop the 510(k) approval process as well as allow U.S. regulators to block medical devices based on past safety concerns.
Why Mesh Recipients Are Considering Vaginal Mesh Lawsuits
There are currently hundreds of lawsuits pending against several of the biggest manufacturers of vaginal mesh, including Johnson & Johnson and Boston Scientific. In February of 2012 more than 500 lawsuits were consolidated into multidistrict litigation allowing the legal claims to be handled in one court. Johnson & Johnson, for one, continues to maintain their vaginal mesh product is safe. In the end, women must learn to be their own health advocates and get all the pertinent facts prior to agreeing to a potentially dangerous surgical procedure.