After it received more than a thousand reports of complications, the U.S. Food and Drug Administration in 2016 reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a Class III device.
The classification means mesh for transvaginal POP repair is among the riskiest medical devices. The most reported complication is mesh erosion, which occurs when the plastic, net-like device pushes through vaginal tissue.
“FDA has determined that the safety and effectiveness of surgical mesh for transvaginal POP repair has not been established and that the collection of additional clinical evidence on these devices is needed,” the FDA said in its 2016 reclassification order.
In a July 2011 notice titled “Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” the FDA concluded that “the risks of serious complications associated with transvaginal POP repair with mesh are not rare.”
Complications may happen immediately after surgery or many years later. Fiona Bicknell from the U.K. calls what she went through a “prolapse mesh nightmare.”
At first, the ProRepair mesh kit Bicknell received helped the symptoms of her prolapse, and she was very happy. Then, about 10 years later, serious complications turned her life upside down.
“Mesh has caused me catastrophic damage both physically and emotionally. I have been suicidal —chronic pain does that to you. I can’t have full sexual relations with the man I have loved for 16 years. I am no longer the fit, active, life-loving person I once was,” Bicknell told Drugwatch in an email.
Dr. Megan Schimpf, an associate professor of urology and obstetrics and gynecology at the University of Michigan, says some complications with mesh surgery may occur because surgeons don’t have proper training.
“We don’t want to get the message out there that all mesh is bad, or that mesh has to be removed simply because other women are having problems,” Schimpf told Michigan Health in May 2018. “Many women are happy and symptom-free after mesh surgery.”
Still, the implant remains controversial. Thousands of transvaginal mesh lawsuits in the U.S. and criticism from the FDA have led doctors and patients to question the device’s safety.
General Complication Rates
Exact numbers may vary depending on the study conducted, but according to a review of a wide variety of studies by D. Barski and D.Y. Deng in BioMed Research International, the complication rate for mesh for transvaginal POP repair is about 15 to 25 percent.
Some studies have found lower complication rates. For example, in a Canadian study published by the International Continence Society, researchers Aube and colleagues said they found complication rates lower than those the FDA found.
The FDA reported 10 percent of patients suffered vaginal extrusion versus 2.6 percent in the Canadian study. Up to 50 percent suffered from painful intercourse in rates reported by the FDA versus less than 2 percent in the Canadian report.
The same authors reported in a separate 2018 study that 37 patients out of 334 required repeat operations. Of those women, 17 had recurrent prolapse and 10 suffered mesh exposure.
Problems Reported to the FDA
In a January 2012 article in OB.GYN. News, Dr. Andrew I. Brill summarized POP adverse events submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database from 2005 to 2010. He told the publication he was a consultant and speaker for Ethicon Endosurgery, Gynecare, Conceptus and Karl Storz.
Brill’s summary ranked the complications from 1 to 10, with erosion as the most reported issue followed by pain and infection. While the ranking included the problems most commonly reported to the FDA, women may experience other issues. For example, Bicknell told Drugwatch she suffers hip pain and urethral burning.
|Complications||Number of Reports|
|Dyspareunia (painful sex)||108|
Removal of mesh, also known as revision surgery, is often the only solution to these issues, but removal is not always possible. Some doctors compare mesh removal to cutting gum out of hair. In many cases, multiple surgeries are required, and there is no guarantee that surgeons can remove all of the mesh.
Of the general mesh complications reported, erosion, pain and organ perforation are some of the more difficult to treat.
Erosion of mesh through the vagina, also called vaginal erosion, is the most commonly reported complication of transvaginal POP repair with surgical mesh. Erosion can be extremely painful, and vaginal erosion usually makes sex too painful to have. Mesh erosion occurs when transvaginal mesh wears through a woman’s internal tissues.
- The mesh can be seen through a tissue.
- The mesh protrudes out of a body structure or tissue.
- An abnormal opening into an organ caused by mesh.
Erosion can affect several other organs besides the vagina. Urinary tract erosion can cause recurring infections and severe pain. Erosion into the bladder or rectum can cause infections, pain and fistulas (abnormal connections).
- Abscesses (pus-filled sores)
- Vaginal discharge
- Vaginal scarring
- Neuro-muscular problems
A 2013 review by David R. Ellington and Holly E. Richter published in Clinical Obstetrics and Gynecology reported previous studies had found erosion occurred in about 10.3 percent of women who received mesh for transvaginal pelvic organ prolapse repair. Other studies have found that erosion rates vary from 7.3 percent to 21 percent, according to a 2012 review published by Hemendra N. Shah and Gopal H. Badlani in the Indian Journal of Urology.
In a 2017 study by Cheng and colleagues published in the Taiwanese Journal of Obstetrics and Gynecology, authors found 47 out of 741 women who underwent mesh repairs suffered erosion. They found women who had hysterectomies and/or hypertension had a greater risk of erosion.
Some doctors have blamed the high rate of erosion or exposure on inexperienced surgeons. A 2015 study by Illston and colleagues looked at the rates of these complications in women who received the Prolift mesh kit implanted by an experienced surgeon. Out of 160 women who completed a survey, 23 had confirmed mesh exposure.
One of the other reasons mesh erosion is such a serious complication is that the rate of occurrence increases over time. For example, a 2018 study by Thierry Vancaillie and colleagues found the erosion rate was 17 percent at one year and it jumped to 42 percent at seven years.
Pain is one of the biggest problems women face after receiving mesh. Ellington and Richter’s review found women reported pain following a mesh procedure in 70 out of 110 studies. Overall, the rate was 9.1 percent. That’s about nine people for every 100.
In one study included in the review, 23 women had mesh removal surgery for complications, and out of 11 women who complained of pain, 10 found relief from pain after the mesh removal.
“I had sharp stabbing pains vaginally that knocked me off my feet. I felt like I had been kicked hard between the legs.”
Ellington and Richter found another observational study that showed the rate of pain during sex was 20 percent. But, the researchers also found a study showing patients who had non-mesh repairs reported more pain during sex than those in the mesh group.
While some women have uncomfortable symptoms from POP before mesh, many women report new pelvic pain — called de novo pain — after the surgery. In a 2017 study by Elizabeth J. Geller and colleagues, 15.6 percent of 160 women reported new onset pain at least a year after surgery. That equates to one in six women, authors wrote. Only about half of the women were sexually active a year after surgery and 19 percent reported painful intercourse.
Geller and colleagues found risk factors for pain after surgery included younger age, early post-operative pain, fibromyalgia and poor physical health.
Organ perforation is defined as the penetration of the wall of an organ in the body. As mesh erodes through internal tissues, it can perforate other organs. This usually happens to the bladder, urethra, bowel or rectum. Doctors consider this one of the most serious complications of mesh surgery because of the risk of infection and organ damage.
Altman and colleagues studied 389 women with pelvic organ prolapse in a 2011 study comparing colporrhaphy, a surgery to repair the vaginal wall, and transvaginal mesh procedures. 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 mesh group, particularly for perforation. These women suffered a 3.5 percent incidence of bladder perforation versus only 0.5 percent in the colporrhaphy group.
On rare occasions, perforation occurs during implantation. This happens when surgical tools puncture the bladder, bowel or blood vessels. One study by Caquant and colleagues followed 684 women after mesh surgery. They found five women had bladder wounds and one had a rectal wound following surgery.
Removing mesh is the first treatment for mesh that is cutting through organs. Surgeons may reconstruct mesh-damaged tissue or cauterize (burn) ruptured blood vessels to stop bleeding. If urine or feces leak from the bladder or bowels, doctors remove the waste using a catheter or other devices. If perforation causes infection, antibiotics are prescribed. Removing mesh may require multiple surgeries.
Please seek the advice of a medical professional before making health care decisions.