Tens of thousands of women suffer through infections, tissue erosion and organ perforation after receiving a transvaginal mesh implant.
Women 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. What they weren’t told was about all of the complications that can arise after surgery — problems that are both painful and difficult to fix.
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 these implants “are not rare.” The agency states that vaginal mesh procedures do not necessarily improve quality of life for patients over standard surgeries and instead can expose them to greater risk.
As of early 2015, an estimated 70,000 women had filed lawsuits against mesh manufacturers after suffering serious injuries from the products.
“I dare to be as bold to say this is almost like genocide on women,” said Teresa Sawyer, who went into surgery for stress urinary incontinence and received a Johnson & Johnson Ethicon TVT sling that has dramatically changed her life – for the worst. Her husband, David, said: “Not a day goes by that we don’t receive emails and phone calls from women that are on the verge of death, literally. It baffles me that this is happening in America – or anywhere.”
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The most critical problems with mesh implants are erosion and organ perforation. Erosion of mesh through the vaginal wall can require multiple surgeries to repair, and there are no guarantees a fix can be made. The mesh can also perforate nearby organs like the bladder.
Erosion refers to the process in which mesh wears through a woman’s soft internal tissues. Erosion can be extremely painful and can lead to exposure – also known as extrusion or protrusion — which means the mesh may be visible externally. Vaginal erosion often leads to painful sexual intercourse (dyspareunia) and may make sex impossible. Urinary tract erosion also can occur, and may lead to recurrent infections.
A 2010 Cochrane review evaluated 3,773 participants in 40 trials of different surgical procedures for pelvic organ prolapse (POP) and found a 10 percent erosion rate when vaginal mesh was used. In its 2011 alert on mesh, the FDA reported “erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh.”
On its website, the FDA also states that “erosion of mesh slings through the vagina is the most commonly reported mesh-specific complication from SUI (stress urinary incontinence) surgeries with mesh. The average reported rate of mesh erosion at one year following SUI surgery with mesh is approximately 2 percent.”
The complication rate for bladder sling operations is actually closer to 4 percent, according to Dr. Jerry Blaivas, who spoke at the annual American Urological Association (AUA) convention in May 2014. Blaivas, clinical professor of urology at Weill Cornell Medical College and attending surgeon at New York Presbyterian Hospital and Lenox Hill Hospital, argued that bladder slings should be considered experimental and that complications are underreported.
Removal of the mesh is often the only solution to erosion, but that is not always possible. Some doctors compare mesh removal to cutting gum out of hair. In some cases, multiple surgeries are required, and even then, mesh pieces may remain.
Organ perforation is defined as the penetration of the wall of a hollow organ in the body. As mesh erodes through internal tissues, it can puncture (perforate) organs — usually the bladder, urethra, bowel or rectum. On rare occasions, perforation occurs during the surgery to implant the mesh.
Severe cases of organ perforation may result in infection and difficulty breathing. Surgery is nearly always required, and may include mesh removal, bowel resection, colostomy and blood transfusion. Perforated organs can leak urine or waste into the bloodstream, which can cause fatal complications like septic shock.
In a 2011 study comparing the colporrhaphy and transvaginal mesh procedures, Swedish researchers studied 389 women with pelvic organ prolapse. Two hundred women underwent transvaginal mesh repairs, and 189 underwent colporrhaphy. All of the women had a prolapse in the anterior (front) vaginal wall.
Complication rates were significantly higher for the transvaginal mesh group, and these women suffered a 3.5 percent greater incidence of bladder perforation.
Of the reports to the FDA regarding prolapse mesh surgery between 2008 and 2010, 5.8 percent involved organ perforation.
Other complications and side effects of vaginal mesh implants can include:
- Severe pelvic, genital or groin pain
- Recurrence of prolapse or incontinence
- Nerve damage
- Vaginal scarring
- Degrading of the mesh
- Infection, including urinary tract infections (UTIs)
- Neuro-muscular problems
- Autoimmune problems
- Vaginal shrinkage or shortening
- Vaginal bleeding
- Blood in the stool or urine
- Painful sexual intercourse
- Urinary retention
- Vaginal discharge
Patients Who Suffered Complications
When Teresa Sawyer went to see her doctor in February 2010 over incontinence issues, she was told that surgery would be a “quick fix.” Her gynecologist assured her that the Gynecare TVT bladder sling that he would implant would fix the problems she was having. Instead, she was forced to endure four painful revision surgeries to try and correct severe complications after the mesh eroded through the vaginal wall.
“Mesh wiped me out of the world,” Sawyer told Drugwatch. “Some days, I could barely get out of bed and walk to the bathroom. It was like walking with knives inside of me.”
She had her mesh removed in November 2011 and made it her life’s mission to reach out to women who have suffered as a result of these products. In June 2012, she received her 501(c)3 status for TVT-No!, which Drugwatch is proud to sponsor. TVT-No! is dedicated to providing transvaginal mesh recipients with information and financial and emotional support.
Christy Hammond was never told about the risks of mesh before her bladder sling was implanted – or that she was having mesh implanted at all.
“A while after surgery, something began happening to my body,” she told Drugwatch. “I was in terrible pain. My pelvic area was on fire. Sex was out of the question because it hurt so bad. I was getting urinary tract infections (UTIs) on a regular basis. There was e-coli in my urine, I learned, after I started going from doctor to doctor wanting to know what was happening, asking them to help me figure out what was going on, I begged for answers.
“The ‘episodes,’ as I call them, increasingly got worse and lasted longer. My side would hurt so bad that I would find myself holding onto that area. Starbursts of needle-like pain would rush over my pelvic area and shoot up my side all day long and into the night. Sleeping was not any better. I would toss and turn, never getting comfortable. My breathing was different. I would get random headaches that would totally consume me.”
“I would have zero energy to do much else. I would have to lay down the moment I got home, and I missed so many activities with my children simply because of my pain,” she said. “I was afraid to go on boats, rides at the fair, anything that would jolt me around for fear of whatever this was, possibly getting worse.”
Hammond learned about mesh from a TV commercial and eventually found a doctor who helped her.
“It had eroded through both sides of my vaginal wall,” she said. “I hold a newfound hope that now that most of the mesh has been removed, my body will start to become healthy again. The possible threat of more surgery remains; only time will tell.”