Pelvic organ prolapse is most likely to occur after a women gives childbirth, has a hysterectomy, or goes through menopause. In this condition, the ligaments supporting the organs weaken and allow the organs to shift out of place. With stress urinary incontinence, the bladder leaks urine when physical activity increases or there is more pressure on the bladder. Transvaginal mesh has been used to provide the necessary support and help women remain healthier and retain good bladder control. Before deciding if this is the right treatment, women are encouraged to learn more about this device and the risks associated with it. In addition to being called transvaginal mesh, it is also referred to as a transvaginal sling or sometimes a bladder sling.
Used by Millions of Women
This medical implant has been used by millions of women who suffer from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Strengthening the muscles of the pelvic floor help women overcome the conditions. The procedure was first introduced in the 1990s and became very popular.
In most cases, the procedure is recommended only when a medical problem occurs as the result of weakened pelvic floor muscles. Most doctors will only perform the procedure once these muscles are too weak to hold up the organs. The device is commonly implanted into the vaginal area, but surgery can also be used to implant it directly into the abdomen.
History of the Mesh
Mesh products used to repair damage inside the body actually date back to the 1950s when they were first used for hernia repairs. Doctors in the 1970s started using this mesh to treat POP and SUI, but they were not marketed specifically for that purpose until the 1990s. Using the larger mesh used for hernias, doctors, would carefully cut the desired shape and size for a custom fit. Manufacturers followed the doctor’s lead and started offering mesh that was made specifically for women to treat POP and SUI.
The first products were offered by Boston Scientific in 1996, and they quickly became a popular option. Manufacturers started offering kits that contained special tools and instructions for doctors to handle the procedure. The first kits were manufactured by American Medical Systems and sold in 1997. Some doctors contend that the problems associated with transvaginal mesh are more closely linked to the use of kits rather than the mesh itself.
Types of Mesh
There are four types of mesh in use currently. Non-abosorbable synthetic can remain in the body indefinitely. More than half of the products on the market fall into this category. Made of polypropylene or plastic, it’s considered a safe option.
Absorbable synthetic products lose strength with time and will break down. It’s not meant to be a long-term solution. The theory is that new tissue will grow over the implant for a strong and durable repair. Biologic mesh is made from animal tissue that has been specially treated to make it safe for use inside the human body. Finally, composite mesh uses any combination of the other three products.
There are two serious complications associated with this treatment. The first is transvaginal mesh erosion that occurs when the mesh actually moves through the vaginal wall. This can result in severe pain, internal bleeding, infection and nerve damage. The mesh has jagged edges that can move through tissue, and they can become exposed. The other serious complication is organ perforation. The mesh can erode through the wall and cause harm to other internal organs, including the bladder. This must be surgically corrected.
However, these are not the only complications that may occur when trasvaginal mesh is used. There can also be nerve damage and vaginal scarring. Scar tissue can build up and cause the vaginal space to essentially shrink, resulting in pain and discomfort. There may be painful intercourse, bleeding, and even emotional problems. Neuro-muscular problems may also occur, as well as a recurrence of the POP or SUI.
One problem that should be considered is the difficult of removing the device. Designed to stay inside the body permanently, it has tiny openings that make it easy for new blood vessels and tissue to grow around the through the device. It is removed in small pieces over the course of multiple surgeries. In one documented case, the woman had to have 18 revision surgeries to treat the problems she had with her transvaginal mesh.
The Role of the FDA
The FDA is expected to carefully review information on products before they’re approved, but the FDA is accused of clearing this device before it was properly studied. It has been shown that the FDA never required testing of this product before it was approved for use on the pelvic floor muscles. The risks and complications were initially revealed through private clinical trial conducted by independent doctors. Only after the alarm bell was raised in other areas did the FDA take a closer look at this product.
The FDA initially approved the use of this product in the 1990s. In October of 2008, they issued warnings of the complications but stated that the complications were rare. In July of 2011, they upgraded the warning to reflect that complications were not rare. They also said that the mesh was not more effective than surgical methods and that it may pose a greater risk. Currently, the FDA continues to monitor the product and review the results of postmarket studies, but it is still available on the open market.
There are several companies involved in federal multidistrict litigations, including C.R. Bard, Ethican Inc. (Johnson & Johnson), American Medical Systems, Coloplast Corp, Boston Scientific Corp. and Cook Medical Inc. One plaintiff was awarded $11.11 million, and another was awarded $5.5 million as a result of injuries and complications. In a June 2013 settlement, American Medical Systems’ parent company agreed to a $54 million payout to settle an undisclosed number of pending suits.
The future of transvaginal mesh is not currently known. While there are surgical alternatives, these also carry certain risks and the potential for complications. Women who are considering this treatment should carefully review all information with their doctors to be certain that it’s the right choice for them. Those who are currently dealing with complications from transvaginal mesh can consult with attorneys to determine if they can pursue the matter through legal channels.