Originally designed for use in hernia surgery, manufacturers more recently began selling surgical mesh products that are inserted vaginally to treat incontinence and pelvic organ prolapse in women.
Surgical mesh was first designed in the 1950s to correct abdominal hernias, which are tears in the abdominal wall where organs or tissues can bulge through. Surgeons enter the abdomen and place the mesh over the tear and staple, suture or glue it in place. It creates a patch over the hernia defect to prevent intestines and other tissues from protruding through the abdominal wall.
Manufacturers make surgical mesh from biological materials such as animal tissue or synthetic materials like polypropylene, polytetrafluoroethylene, polyester fibers or stainless steel. Some hernia meshes are coated to protect organs. The size, shape, thickness and flexibility vary based on the surgeon’s needs. Often, the mesh comes in a prepackaged kit with the necessary tools, to make the procedure easier.
The Food and Drug Administration (FDA) reports that about 800,000 hernia repair surgeries are performed each year — with and without surgical mesh — and patients typically recover quickly. Doctors prefer hernia repair with mesh because it reduces the risk of hernia recurrence. However, the FDA has received reports of adverse reactions to the mesh including adhesions (where the loops of the intestines attach to each other or the mesh) and injury to organs, nerves or blood vessels. It may also cause allergic reactions, swelling and infections.
Overall, doctors consider the treatment of hernias with surgical mesh successful. In the 1970s, surgeons began inserting surgical mesh abdominally to treat pelvic organ prolapse (POP) before the FDA approved it for this use. This spurred a new market for surgical mesh used in gynecological procedures such as incontinence and organ prolapse. In 1996, the FDA approved the first vaginal mesh product for the treatment of stress urinary incontinence (SUI). The first vaginal mesh product for the treatment of prolapse was approved in 2002.
Instead of inserting the mesh through abdominal incisions, however, surgeons have recently embraced the idea of implanting the mesh transvaginally (through the vagina). This choice has been disastrous for thousands of women, who have suffered severe complications such as organ perforation and erosion of the mesh. Even multiple surgeries cannot always remove the mesh or correct the internal trauma.
Transvaginal Mesh and Pelvic Organ Prolapse
To treat pelvic organ prolapse, surgical mesh can be implanted at the time of a hysterectomy or as a separate surgery. When surgical mesh is inserted through the vagina, it is referred to as transvaginal mesh.
Pelvic organ prolapse is a condition in which the bladder, top of the vagina, uterus, rectum or bowel has descended from its normal position. The condition is thought to be the result of weakened pelvic muscles, usually from pregnancy and childbirth. Of the 300,000 surgical procedures done to correct prolapse in 2010, 100,000 used mesh and 75,000 of those were completed transvaginally.
When vaginal mesh is used to repair prolapse, the surgeon uses the woven material to create a hammock-like structure under the drooping organ or organs. Once in place, the mesh is anchored to muscles or ligaments by sutures or other devices. Over time, the patient’s tissues grow and fill in the pores of the mesh to keep it stable. The hammock, in turn, maintains the correct position of the affected organ.
|To treat prolapse, transvaginal mesh is most commonly placed in these locations:|
|The anterior vaginal wall to correct a bladder prolapse.|
|The posterior vaginal wall to correct a rectal prolapse.|
|The top of the vagina to correct a uterine prolapse.|
The most common and serious of the complications for patients is the erosion, or extrusion, of the mesh into nearby organs. This can lead to bleeding, pain during sexual intercourse and urinary problems. Revision surgeries may not fix the problem. And if the patient’s tissues have already grown through the mesh, removal may be impossible.
Transvaginal Mesh and Stress Urinary Incontinence
Surgical mesh can also be used to create a bladder sling that is positioned under the urethra and bladder neck and anchored on the sides. The bladder sling is designed to treat stress urinary incontinence (SUI), which occurs when the bladder is stressed by an everyday activity, such as sneezing or laughing, and subsequently leaks urine. The sling keeps the urethra and bladder neck closed during normal activities, stopping the leakage. In 2010, nearly 260,000 surgeries were performed to correct SUI. Of those, 80 percent were performed using surgical mesh implanted transvaginally.
When a bladder sling is inserted through the vagina, it is known as transvaginal mesh. Typically, small abdominal incisions are also used.
|Among the most popular bladder slings:|
|Tension-free vaginal tape (TVT): A polypropylene mesh tape is used under the urethra and is held in place by the patient’s body.|
|Transobturator tape (TOT): Less invasive than TVT, because there is no need to use a large needle when inserting it.|
|Mini-sling: Eliminates the need for abdominal incisions. A metallic inserter and a vaginal incision are used to place the mesh tape.|
As with prolapse surgery, there have been widespread reports of serious complications after bladder sling surgery using transvaginal mesh. Many patients have prolonged difficulty urinating or they incur new symptoms of incontinence, specifically urgency. In addition, they run the risk of the slings eroding into nearby structures, organ perforation, infection at the surgery site and internal bleeding.
Transvaginal Mesh and the FDA
Between 2005 and 2007, the FDA received 1,000 reports of complications and injuries related to transvaginal mesh surgeries, including death. The FDA decided to begin studying the medical device in October 2008. The FDA reported that between 2008 and 2010, there were nearly 2,900 reports of injuries caused by transvaginal mesh.
By July 2011, the federal agency concluded in a public safety update that complications with the use of transvaginal mesh for treatment of prolapse are not rare and that mesh repairs are no more effective than non-mesh repairs for treating prolapse.
The FDA took its concern a step further in January 2012, stating that after studying years of scientific data and recommendations from the September 2011 Obstetrics-Gynecology Devices Panel meeting, it was considering reclassifying transvaginal mesh as a high-risk device. If that happens, mesh devices will be subjected to more rigorous testing, including clinical trials with humans.
In that same update, the FDA requested safety data from all surgical mesh manufacturers and ordered post-market studies from seven manufacturers of single-incision mini-slings for SUI and 33 manufacturers of surgical mesh for prolapse.