Transvaginal mesh surgery — in which surgical mesh is implanted through the vagina — was introduced in the 1990s and was hailed as a breakthrough in the treatment of pelvic floor disorders that are common
in women after childbirth, hysterectomy or menopause. Since that time,
mesh procedures have become widely used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
However, as the number of mesh procedures have risen, so too have reports of serious complications and lawsuits over those complications — which have brought transvaginal mesh surgery under increasing scrutiny from Food and Drug Administration (FDA) officials and medical experts.
Transvaginal mesh was cleared by the FDA for use in SUI procedures in 1996 and for POP repair in 2002. However, these implants were cleared under the 510(k) process, which is the regulatory path through which many medical devices are allowed to enter the marketplace.
Under this process, medical device manufactures need only demonstrate that their product has “substantial equivalence” to a device that is already on the market, which means there is no requirement for manufacturers to perform clinical trials to prove safety and efficacy.
In the years following that streamlined approval, transvaginal mesh surgery has become widely used. The FDA indicates that in 2010, 208,000 women had SUI repair procedures that used the devices and about 75,000 transvaginal mesh POP procedures were done.
As the frequency of the procedures increased, adverse events rose as well, prompting FDA officials to release a Public Health Notification on the matter in October 2008 to advise medical professionals and patients of complications related to these devices. In July 2011, the FDA released an update to that alert, stating that reports of serious complications had risen dramatically since the 2008 alert.
In the 2011 update, the FDA stated that the most frequently reported complications were mesh "erosion through the vagina ... pain, infection, bleeding, pain during sexual intercourse ... organ perforation and urinary problems, [as well as] reports of recurrent prolapse, neuro-muscular problems, vaginal scarring and shrinkage and emotional problems."
The update also detailed the consequences of mesh shrinkage, describing it as a previously unidentified risk where the mesh contracts in the body, which can lead to severe pelvic pain, painful intercourse or an inability to engage in sex.
Another unfortunate reality for the thousands of women who suffer
serious complications from these procedures is that revision surgery is
often necessary to address the problems and it doesn't always work.
Removing the mesh is difficult, since tissues grow into and around the
mesh, and some women still suffer symptoms after multiple surgeries.
These complications are so drastic and many women have no choice but to
live with the complications. For that reason, thousands of women have
begun to file transvaginal mesh lawsuits against manufacturers of the mesh products.
In its 2011 update, the FDA stated that it is not clear that mesh procedures are any more effective than traditional non-mesh surgeries and urged surgeons to consider other methods. Since most cases of POP and SUI can be resolved without the use of transvaginal mesh, women would be wise to take that advice seriously and make sure to speak to their doctors about alternatives to transvaginal mesh procedures.
Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.