When complications occur after a vaginal mesh device is implanted, doctors may have to remove it. But since the mesh was not designed to come out, women may have to undergo several painful revision surgeries to correct complications.
The synthetic mesh hammocks are supposed to fix prolapse and incontinence. Instead, they often damage internal organs. Scores of women now are turning to surgeons — specifically urogynecologists — to remove the faulty mesh and may face more problems than before. Removal of the mesh is not always possible, even after several surgeries.
The type and severity of the complication determine the type of revision surgery.
|Complications arising from the first surgery that could necessitate another procedure include:|
|Mesh erosion and extrusion|
|Obstruction of the urethra|
|Injuries to bowel or bladder (perforation)|
|Injuries to blood vessels (with massive hemorrhage)|
|Injuries to nerves|
From 2008 to 2010, the U.S. Food and Administration (FDA) received nearly 3,000 reports of adverse events related to the mesh. While all of them did not require revision surgery, also called excision, some women underwent three or more surgeries.
Some women turn to physical therapy for relief, says Amy Robinson of Clear Passage Physical Therapy.
“When a patient comes to physical therapy they’ve often been to multiple physicians because they are having issues, and often times it seems such as back pain and pelvic pain, inability to sustain intercourse either because there is too much pain or they just cannot even attempt full penetration,” she told Drugwatch Radio. “You’re looking at pain as a whole with these women. A lot of them complain that they cannot sit and that they have horrendous abdominal pain. There’s a whole realm of issues that go together when women have complications with mesh. It’s not, a lot of times, just in the pelvic region itself.”
Revision Surgery on the Rise
Introduced to the market in the 1990s, transvaginal mesh is implanted through the vagina to correct pelvic organ prolapse, which can happen in all women but typically occurs in older females after childbirth, a hysterectomy or menopause. Because of weakened muscles, internal organs, including the uterus, bladder and bowels, shift into the vagina. If not repaired, a prolapse can be very painful and cause a host of medical problems.
Transvaginal mesh is also used to correct incontinence, which is also the result of weakened pelvic muscles. When mesh is used in this procedure, it is called a bladder sling.
For decades, doctors fixed prolapses and incontinence with traditional surgery to tighten ligaments and muscles. When surgical mesh was introduced, it was happily received by the medical community. It was hailed as a faster, easier fix. In 2010 alone, nearly 300,000 transvaginal mesh surgeries were performed in the United States.
However, studies show that the polypropylene mesh can slice through vaginal walls, injuring nearby organs. It can also cause abscesses, pain, vaginal bleeding, sexual dysfunction and recurrent prolapse or incontinence. The mesh is also known to shrink after implantation, causing pain and sexual dysfunction.
Erosion and extrusion — where pieces of the mesh are exposed through the vaginal skin — can be the result of the surgeon’s operative technique, the size and style of the implanted device or placement of the mesh too close to the bladder. Delayed erosion and extrusion can occur when the body rejects the less-porous mesh materials and when the mesh is attached in the wrong place.
Aftermath of Transvaginal Mesh Revision Surgeries
When a bladder sling needs to be repositioned after surgery, patients may choose to have a new sling implanted. They usually must endure months of incontinence and pain while doctors determine how the first sling is performing. When it is finally time for the revision surgery, patients can face a host of other problems because removing a faulty sling and replacing it with a new one is a complex corrective surgery.
When mesh is used to correct prolapse, women who are suffering may not have the option of keeping the device in. But getting it out isn’t easy.
It can take three or more revision surgeries to remove it completely. Take, for example, the case of Janet Holt of San Antonio, Texas. Four years after her initial prolapse surgery, the 50-year-old told MSNBC.com, she underwent seven surgeries to remove it.
The process to remove the mesh is time consuming, painful and difficult. It takes a skilled surgeon to remove pieces of fine mesh that have fused with nearby organs and tissues.
“Surgical mesh is considered permanent and complete removal may not be possible,” said Cheryl B. Iglesia, M.D., of the American Congress of Obstetricians and Gynecologists. “Multiple surgeries may be required to remove the mesh in those women with complications, but even if successful, this may not resolve the problems entirely for a small number of women.”
In removing the mesh, surgeons need to excise the surrounding tissues gently. That typically involves cutting out mesh and surrounding tissue and then stitching the area.
Once that’s done, then the initial problem – the prolapse – needs to be addressed. Most doctors are reverting back to traditional fixes, which do not carry the same risks as the transvaginal procedure.
A study presented at the annual meeting of the Society of Gynecologic Surgeons looked at 19 women who had undergone transvaginal mesh removal. Most of the patients reported mesh erosion, recurrent pelvic prolapse, chronic pain and sexual dysfunction as the reasons for removal.
Once the excision was completed, one of the patients in the study had to get a blood transfusion because of a rectovaginal hematoma.
“Most of the women (87 percent) said that they would not have had the original mesh placement if they knew what they know now,” the study stated.
Transvaginal Mesh Lawsuits
After suffering from incapacitating pelvic pain, undergoing several surgeries to repair the problems and spending thousands of dollars on recovery, many women and their families are filing transvaginal mesh lawsuits.
What is at issue here is not just the transvaginal mesh, but also the FDA’s approval system for medical devices. Since 1976, countless medical devices have slipped through the FDA’s testing guidelines under its controversial 510(k) clearance program. This allows quick FDA approval under the premise that new devices are safe if they are similar to ones already on the market.
That’s what happened with transvaginal mesh. An initial product, Boston Scientific’s ProteGen, was marketed in 1996, but then voluntarily recalled three years later because of safety concerns. Since then, dozens of transvaginal mesh devices have been able to sidestep premarket testing by claiming their product is similar to ProteGen. New legislation is before Congress to shore up these rules.
Also, multidistrict litigation (MDL) has been established in West Virginia with thousands of cases pending. The manufacturers involved are American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon, C.R Bard, Coloplast, Cook Medical and Neomedic Pelvic Repair System.
A sixth MDL, involving dozens of lawsuits over the defective Mentor ObTape, is taking place in the U.S. District Court for the Middle District of Georgia. The MDL, presided over by Judge Clay D. Land. According to the United States Judicial Panel on Multidistrict Litigation, as of June 2015, there are over 400 cases still pending in federal court, though J&J offered to settle about 100 cases.
About 35,000 women in the United States have had a mesh implant that used ObTape, but only a fraction of patients have come forward to seek recourse.