However, as these implants came into popular use, reports of serious complications associated with transvaginal mesh procedures began to emerge. As those reports have increased in numbers dramatically over the past three years, they have raised significant concerns about the safety of treating POP with transvaginal mesh.
Pelvic Organ Prolapse
A very common pelvic floor disorder, POP affects about half of all childbearing women. It is the result of weakening and stretching in the muscles and connective tissues of the pelvic floor, which is the structure that holds pelvic organs, like the uterus and rectum, in place.
POP happens when the pelvic floor becomes too weak to perform that function, allowing one or more of those organs to drop and place pressure on the vagina. While the condition is not life-threatening, severe cases of POP can cause significant interference in bladder, bowel and sexual function. Corrective surgery in such cases can restore a woman's quality of life.
Pelvic Organ Prolapse and Transvaginal Mesh Procedures
The use of transvaginal mesh in POP repair procedures has become prevalent in recent years. These devices generally come in the form of prepackaged kits configured for specific types of POP, many made in a hammock-like design to support prolapsed organs. They are inserted into the pelvic cavity through the vagina and are meant to become a permanent fixture to enhance pelvic support. In 2010 alone, these devices were implanted in 75,000 American women for the treatment of POP.
Transvaginal Mesh and the FDA
Transvaginal mesh was cleared for use in POP treatment through the FDA's 510(k) process, which approves medical devices based on “substantial equivalence” to a product already on the market. This streamlined approval process often requires no clinical evidence to be provided on safety and efficacy.
In the years following FDA approval, as use of these devices increased, so too did reports of serious complications. In 2008, the FDA released a safety alert on transvaginal mesh, advising medical practitioners and patients of complications with the use of mesh implants. In an update to that safety alert, released in 2011, the FDA stated that reports of serious complications had risen five-fold since that 2008 alert.
According to the 2011 update, the most frequently reported complications were mesh erosion, protrusion through vaginal walls, organ perforation, recurrent prolapse, neuro-muscular problems, mesh shrinkage and vaginal scarring. These complications can result in pain, infection, bleeding, sexual dysfunction and urinary problems.
Many women have required revision surgery due to these issues, and those procedures are not always effective in reliving their symptoms. Some women must live with the complications for the rest of their lives; many women have even filed transvaginal mesh lawsuits against mesh manufacturers to seek compensation for their injuries. The FDA advises that most POP cases can be resolved without the use of mesh, and urges surgeons and patients to consider traditional POP repair as a safer alternative to the use of transvaginal mesh implants.