They were told it would be a quick and easy fix for pelvic organ prolapse or incontinence. A simple, hammock-like piece of mesh would be implanted through the vagina to support pelvic organs. They weren’t told about all of the complications that can arise after surgery — problems that are both painful and difficult to fix.
Hundreds of thousands of women have received transvaginal mesh implants to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Serious complications have affected thousands of these women since the surgical devices were introduced in the late 1990s.
Once hailed as a breakthrough solution to medical issues that plague women after childbirth and menopause, the mesh implants have been shown to be a risky choice. Furthermore, manufacturers of the implants are accused of failing to disclose the possible complications associated with their products.
The U.S. Food and Drug Administration (FDA) issued a warning in October 2008 about the rate of complications with transvaginal mesh procedures and decided to review 15 years of scientific data to determine the procedure’s effectiveness.
In July 2011, the FDA reported that it had received nearly 4,000 complaints of injury, death or malfunction associated with transvaginal mesh surgeries performed between 2005 and 2010. The FDA concluded that complications from transvaginal mesh implants were not rare. The agency has stated that mesh procedures do not necessarily improve quality of life for patients over standard surgeries and instead can expose them to greater risk.
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Serious Complications of Transvaginal Mesh
The most critical problems with transvaginal mesh are erosion and organ perforation. Erosion of mesh through the vaginal wall can require multiple surgeries to repair, but there are no guarantees a fix can be made. The mesh can also perforate nearby organs.
Within one year of a transvaginal mesh procedure to fix prolapse, up to 10 percent of women experience mesh erosion or failure. Also, men may experience pain to the penis during sexual intercourse when the mesh is exposed.
The mesh is also known to shrink or contract once inside the vaginal area, which can cause vaginal shrinkage and severe pain. It can lead to severe pelvic pain, painful sexual intercourse, or an inability to have sexual intercourse.
The mesh is also known to cause severe pain and sustained bleeding. Worse, the main problem the mesh is designed to repair — prolapse or incontinence — may not be fixed.
|Other complications of transvaginal mesh include:|
|Urinary tract infection|
|Need for a repeat surgery|
A study published in the May 12, 2011, issue of the New England Journal of Medicine found that risks and complications are higher for women who have a small piece of mesh — known as a bladder sling — inserted transvaginally to repair incontinence. Researchers compared these women with those who had a traditional incontinence repair that involved stitching their own tissue together.
|Among the findings:|
|Pelvic bleeding and bladder perforation are more common with the mesh implant.|
|Rates of new stress urinary incontinence after surgery were higher for women in the mesh group.|
|More women in the mesh group reported pain during intercourse than those who received standard procedures.|
|In the mesh-repair group, 3.2 percent had to undergo revision surgeries to correct mesh-related complications.|
Transvaginal Mesh May Require Revision Surgery
With nearly 300,000 transvaginal mesh procedures completed in 2010 alone, hundreds of women are coming forward to have the mesh trimmed or removed.
The removal surgery, called revision surgery or excision, is tricky because surrounding tissue often grows through and around the mesh. This makes it very difficult for doctors to completely remove the mesh in one procedure. One patient likened the excision process to “removing gum from your hair.”
Women can face infections, including sepsis, and even death.
Transvaginal Mesh Skirts Premarket Testing
It’s likely that the problems associated with transvaginal mesh didn’t start with the mesh itself, but with the lack of premarket testing. The device was approved under the FDA’s fast-track 510 (k) premarket notification process.
The decades-old process allows fast approval for medical devices that are considered to be “substantially equivalent” to a device already on the market. That was the case for dozens of styles of mesh on the market today.
Health care advocates are now pushing for transvaginal mesh to be reclassified as a Class III device, which would require extensive premarket clinical trials for safety and effectiveness, inspections of the manufacturing facilities and post-market studies. Some of those same advocates are also calling for the mesh to be recalled.
FDA Does Not Support Transvaginal Mesh Recall
In the 1990s, the medical device company Boston Scientific introduced ProteGen, the first vaginally implanted mesh to treat prolapse. By 1999, the company had voluntarily recalled about 20,000 of its devices, saying the mesh was causing discomfort, painful sex and erosion of vaginal and surrounding tissue. But by that point, several other manufactures were already producing similar mesh devices.
It’s unlikely a nationwide recall will happen soon. A 15-member FDA advisory committee that met in September 2011 said it would not support a recall, but would support reclassifying the device to allow for more stringent premarket testing. The FDA is not required to follow the committee’s decisions.
The FDA is requesting data on the safety and effectiveness of transvaginal surgical mesh implants from dozens of mesh manufacturers.
FDA Distances Itself from the Issue
With the influx of complaints about transvaginal mesh complications and several reported deaths, the FDA has been taking steps to distance itself from its previous claims that problems with the device are rare.
Thousands of women and their families have filed lawsuits against the five primary mesh manufacturers — American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon, C.R. Bard and Coloplast. Because all of the complaints are based on the same facts — that the mesh erodes and causes severe pain — they have been consolidated into multidistrict litigation (MDL). This allows a large number of mesh lawsuits to be managed in one court, which cuts costs and improves efficiency.