After a woman experiences childbirth, has a hysterectomy, or goes through menopause, she is more likely to experience a pelvic organ prolapse. In this condition the ligaments supporting the organs weaken and allow the organs to shift out of place. Urine leaks from the bladder with urinary incontinence when physical activity increases or pressure is increased on the bladder. Transvaginal mesh has been used to support women and help them regain control of their bladder. Transvaginal mesh is also referred to as a transvaginal sling or sometimes a bladder sling.
The transvaginal mesh procedure was first introduced in1990s and became very popular. This medical implant has been used by millions of women who have pelvic organ prolapse and stress urinary incontinence by strengthening the pelvic floor.
The procedure is mostly performed only after a medical problem has already occurred as the result of weakened pelvic floor muscles. Most doctors will only recommend the procedure once the muscles are too weak to support organs. The mesh is most commonly implanted into the vaginal area, but can also be implanted directly into the abdomen.
Products similar to transvaginal mesh have been used to repair damage inside the body since the 1950s when they were firs used for hernia repairs. During the 1970s, doctors begain using this mesh to treat pelvic organ prolapse and stress urinary incontinence; however, they were not marketed for that purpose until the 1990s. Boston Scientific first offered the product in 1996.
There are four types of mesh currently available on the market. Non-absorbable synthetic mesh can stay in the body indefinitely. Over half the available mesh products fall into this category. It is made of plastic and is considered a safe option. Absorbable synthetic mesh will weaken over time and will eventually break down. These are not meant to be a long-term solution. The hope is that new tissue will grow over the implant for a strong repair. Biological mesh is derived from animal tissue and is made safe for use within the human body. Composite mesh is a combination of any of the three other types of mesh.
There are two major complications linked to transvaginal mesh treatment. The first risk is mesh erosion, which occurs when the mesh goes through the vaginal wall. This causes severe pain, internal bleeding, infection, and nerve damage. The mesh has sharp edges that, if exposed, can cut through tissue. The second serious risk is organ perforation. The mesh can erode through the vaginal wall and cause harm to other organs, including the bladder.
These are not the only complications that occur when using this product. Nerve damage and vaginal scarring are also possible. Scar tissue build up can cause vaginal space to shrink, resulting in pain and discomfort. Painful intercourse, bleeding, and emotional problems can occur. Neuro-muscular problems may also occur, as well as a recurrence of pelvic organ prolapse or stress urinary incontinence.
Removing the device is also very difficult. The mesh is designed to stay in the body permanently, and is made with tiny opening for new blood vessels and tissue to grow around the mesh. It must be taken out piece by piece over the course of multiple surgeries. One woman had to endure 18 revision surgeries to treat the problems linked to her transvaginal mesh.
The FDA is accused of clearing transvaginal mesh for use before it was properly studied. The FDA never required testing for its use on the pelvic floor muscles. The risks and complications were discovered through private research conducted by independent doctors. The FDA only took a closer look at transvaginal mesh after the alarm was raised.In 2008 the FDA released warning about the complications, but stated that the complications were rare. In 2011, they upgraded their warnings to state that the complications were not rare. They also stated that the mesh was not more effective than other surgical methods, and that it may pose greater risks. . The FDA is still reviewing the product, but it is still available on the market.
There are several companies involved in federal multidistrict lawsuits. One plaintiff was awarded $11.11 million, and another was awarded $5.5 million. In June 2013, American Medical Systems agreed to a $54 million payment to settle an undisclosed number of pending lawsuits. The future of transvaginal mesh is not currently known. There are alternatives to using transvaginal mesh, but they also come with risks. Those who are currently dealing with damages from transvaginal mesh should consult legal professionals to discuss their rights and legal options. If you or someone you know has been injured by transvaginal mesh call the Law Offices of John Michael Bailey right away.