Pelvic Organ Prolapse and the Use of Transvaginal Mesh

This week is a guest post from Jasmine McCarthy who works in the Public Outreach Department from www.drugwatch.com.

Pelvic organ prolapse (POP) is a condition that occurs when the internal structures that support pelvic organs become weakened or stretched to the point that they allow those organs to fall lower in the body, pressing into the vagina. While POP is not life-threatening, severe cases can cause an array of symptoms that have a substantial effect on a woman's quality of life.

Corrective surgery is often recommended in such cases, which can resolve symptoms in many women. However, over the last decade, the use of transvaginal mesh implants has become common in POP repair surgeries — an addition that has proven problematic for a significant number of women who have undergone these procedures.

Pelvic Organ Prolapse

Pelvic organs, such as the bladder, uterus and rectum, are supported by the pelvic floor, which is made up of muscles and connective tissues. Over a woman's lifetime, the pelvic floor can be gradually weakened and stretched as it is exposed to stress. The most common cause of that damage is childbirth, but factors like obesity, chronic constipation and a family history of POP can contribute.

When the pelvic floor is weakened significantly, one or several of the pelvic organs can drop out of their normal position, placing pressure on the vagina. Mild cases may produce no symptoms, but women with more serious POP may experience symptoms that include pain and pressure in the pelvic region, urinary leakage, difficult bowel movements, pain during sex, a bulge in the vagina, or organs that protrude through the vaginal opening.

Transvaginal Mesh and POP Procedures

Approved by the Food and Drug Administration (FDA) for POP repair procedures in 2002, transvaginal mesh is a medical device that is permanently implanted in patients to reinforce the weakened tissues that are at the root of pelvic organ prolapse. Constructed of synthetic surgical mesh, these devices are hammock-like in design to support prolapsed pelvic organs and are inserted into the pelvic region through the vagina. This method of POP repair has become quite prevalent, used in 75,000 procedures in 2010 alone.

Complications

The most common complication associated with transvaginal use for pelvic organ prolapse repair is mesh erosion. Also referred to as mesh extrusion, this occurs when rough edges of the mesh cut through the vaginal tissue and nearby organs. Results of mesh erosion can include organ perforation, infection, bleeding, pain, urinary issues and sexual dysfunction.

Mesh shrinkage is another common problem, and can cause vaginal shortening and intense pain. Addressing these complications often requires multiple surgeries, and since tissues grow into and around the mesh implants, they are not always effective. Thousands of women have been affected by these complications and have filed transvaginal mesh lawsuits against mesh manufacturers.

FDA Information

In a 2011 alert, the agency reported the results of a systematic review of scientific studies on the use of transvaginal mesh in pelvic surgeries. Those results showed that there is a significant risk of serious complications with the use of these products, and that those risks came with no significant benefits, since procedures that use transvaginal have not proven to be more effective than traditional POP repair.

According to that report, among the most common complications reported were mesh erosion, mesh shrinkage, organ perforation and infection, and reports of these serious complications rose fivefold between 2008 and 2010, as compared with reports during the previous three years.