Vaginal Mesh Implants
For the thousands of women a year who are diagnosed with pelvic organ prolapse (POP) or stress urinary incontinence (SUI), vaginal mesh implants were billed as the perfect fix to an uncomfortable and painful problem. But with an increasing number of women suffering from severe side effects as a result of faulty mesh, federal regulators and medical professionals have put the brakes on this surgical fix.
While the U.S. Food and Drug Administration (FDA) has yet to issue a mesh recall, many doctors and surgeons have been taking the situation seriously and refusing to use the devices. Thousands of women have reported injuries from vaginal mesh, which is also known as transvaginal mesh because of the way it is surgically implanted.
What is Transvaginal Mesh?
While surgical mesh has been used for decades to fix hernias, its more recent use has been transvaginally. The mesh is made from a flexible plastic and looks like a little hammock. It is inserted vaginally and surgically sewn into place, as opposed to abdominal-incision placement. Its aim is to support organs – namely the bladder, rectum and uterus – that fall into the vagina due to weakened pelvic muscles from menopause, a hysterectomy or childbirth. It is also used to hold up the bladder as a mean to stop urinary incontinence.
All of the transvaginal mesh devices on the market today are modeled after one design – Boston Scientific's ProteGen mesh device – that was recalled in the 1990s. Although the ProteGen device was only on the market for a few years, it paved the way for similar shoddy devices. Because of lax FDA rules, today's mesh manufacturers have been able to piggyback on ProteGen's entry into the market. Mesh manufacturers that include Boston Scientific, Johnson & Johnson's Ethicon division, C.R. Bard and American Medical Systems have been able to circumvent any clinical trials and testing and put the devices directly into doctors' hands.
Long before the FDA acknowledged a problem with transvaginal mesh devices, medical researchers saw the difficulties. In 2009, researchers put an abrupt stop to a study reviewing mesh and its complications. The study, which ran in the journal Obstetrics & Gynecology, found that more than 15 percent of mesh patients experienced erosion, resulting in pain and infection. "The bottom line is not only there were more complications, but the mesh didn't prove any better than traditional surgery," the lead researcher told The New York Times. By 2011, the FDA conceded that problems with mesh are "not rare" and can be very serious.
Common Side Effects of Vaginal Mesh Implants
The most serious side effect resulting from mesh implants is mesh erosion, which happens when pieces of the mesh fall apart, form sharp edges and puncture nearby organs. The resulting effects include uncontrollable bleeding, infections and organ perforation. Often, women choose to have the mesh removed, but it is a tricky surgery. However, some skilled surgeons are having limited success in this emerging field of medicine.
Another common side effect is mesh shrinkage. While it's not completely clear why the mesh shrinks, some research suggests it may happen due to an immune response. Again, surgical removal for mesh shrinkage is the only answer. Probably the most frustrating part of all the mesh problems is that research shows that mesh does not fix POP or SUI.