Once hailed as a simple fix for pelvic organ prolapse (POP) or stress urinary incontinence (SUI), transvaginal mesh implants have instead resulted in thousands of complaints, complications, and lawsuits.
Surgical mesh, both synthetic and animal-based, is a hammock-like device developed to support tissue that was weakened or damaged in some way. It became a go-to option for treating the weak muscles and ligaments allowing a woman’s pelvic organs to slip out of place (prolapse). One way to insert the mesh is through the abdomen, but a less-invasive way is through the vagina. The transvaginal method also allowed for practitioners not qualified to perform abdominal surgery to insert mesh. When a similar weakening occurs with a woman’s bladder, the mesh can be implanted to shore up the urethra or bladder neck. This mesh sling procedure, also done through the vagina, treats SUI, where a small loss of urine results from the most innocuous of physical movement – laughing, sneezing – causing stress on the bladder.
This so-called simple way to treat POP and SUI has resulted in almost 4,000 complaints to the U.S. Food and Drug Administration (FDA) between 2005 and 2010. Nearly three-quarters of the reports occurred in the three years from 2008 to 2010. The complaints prompted two FDA Public Health Notifications, one in 2008 and an update to it in 2011. The original notice was an alert to healthcare providers of the serious complications reported to the FDA between 2005 and 2007 regarding transvaginal mesh implants and recommendations for mitigating these issues. The update in July of 2011, following nearly 3,000 additional complaints, was addressed to both healthcare providers and potential patients. The significant difference in this update was the agency’s declaration that the complications from transvaginal mesh treatment of POP are “not rare.” A January 2016 press release upgraded the mesh implants from a moderate-risk device to a high-risk one, as well as requiring rigorous pre-market approval applications, even for those already on the market. Previously, mesh products were not subject to the same scrupulous approvals by the FDA as new drugs. Manufacturers needed only to show that their product was “substantially” the same as others like it currently on the market. Mainly, because one mesh product was already available through little-to-no scrutiny, all others could be sold as well.
The most common Transvaginal Mesh complications reported to the FDA include:
- Pain and discomfort
- Urinary troubles
- Prolapse Recurrence
- Organ perforation
- Vaginal scarring
- Dyspareunia (pain during intercourse)
When the mesh moves from its intended location, can be seen in a separation of the vaginal lining or causes a perforation, it’s called erosion. The FDA reports erosion is the most common complication from transvaginal mesh implants. A painful condition, erosion often requires multiple surgeries to try to remove the mesh. The FDA notes the results could be debilitating for some patients, and the surgeries may not always correct the problem.
Medical device reports (MDR) sent to the FDA between 2008 and 2010 on 1,503 surgical mesh used for POP showed 528 instances, more than 35 percent, of erosion. The second round of MDR for mesh used to treat SUI showed nearly 32 percent experienced erosion. A 2011 review of over 100 studies (11,785 women) of mesh used for POP repair found over 10 percent of patients suffered erosion within a year of their surgery.
The POP MDR the FDA used above showed 253 incidents, almost 17 percent, of infection from transvaginal mesh. The SUI MDR evaluation of 1,371 women reported 260 patients, or nearly 19 percent, suffered an infection from their mesh implant.
Movement of the mesh or problems with the placement of it can result in punctures in surrounding organs. The organs most often perforated include the bladder, rectum, lower intestines and blood vessels surrounding the pelvic area.
Symptoms of bladder perforation include blood in the urine, pain with or the inability to urinate, and cramping. Rectum and intestinal perforation present with abdominal pain or swelling, vomiting, bloody stool or blood pressure changes. Perforation of the blood vessels may also cause swelling, blood in waste, vaginal bleeding, and overall weakness.
In the FDA’s MDRs, 88 instances of organ perforation occurred when mesh was used to treat POP and 110 instances in SUI treatment. At least two deaths in each MDR were related to an organ perforation, most often the bowels.
Other Adverse Effects
The two MDRs list several other issues mesh patients experienced, some a result of the most serious complications and others encountered in isolation. They include:
- General Pain – 34.9 percent of SUI patients and 31.4 percent of POP patients
- Bleeding – 124 POP patients and 103 SUI patients
- Dyspareunia – 108 POP patients and 73 SUI patients
- Urinary Issues – 16 percent of SUI patients and 5.3 percent of POP patients
- Neuro-Muscular Problems – 50 SUI patients and 38 POP patients
Patients Who Suffered Transvaginal Mesh Complications
WBUR’s Rachel Zimmerman interviewed six women who testified in front of an FDA advisory panel in September of 2011 about their traumas after undergoing transvaginal mesh implantation. The women estimated they had 45 surgeries between them to try to correct the damage done by the procedures.
Amy Gezon, 43 at the time, called her resulting pain “the most horrendous” she’d ever felt. The mother of three wound up in the emergency room and said she was unaware of the multitude of issues associated with the surgery. Had she known even a minimum of it, she says, wouldn’t have undergone the procedure.
Transvaginal Mesh Lawsuits
Zimmerman also spoke to 44-year old Linda, who didn’t want her last name used to avoid issues with her then-pending legal case against a mesh manufacturer. The Pennsylvania mother of three found her bladder had fallen and was pressing into her vagina. Her doctor described the transvaginal mesh surgery as simple and nothing to be concerned about. Linda says the terrible pain began immediately after the surgery, as did the bloody urine. Her bladder had been punctured and required emergency surgery. Along with bleeding, blood clots, and erosion to the point that her husband could feel the mesh during sex, she suffered severe incontinence. “I’m leaking all the time now…It’s been a nightmare,” she told Zimmerman. “You’re going to be my patient for life,” Linda says a doctor told her regarding her post-mesh prognosis.
Manufacturers of various transvaginal mesh kits and implants have faced hundreds of lawsuits, many combined in the courts, over the past five years. Between 2014 and April of 2016, judgments totaling nearly half a billion dollars have been handed down to them. Although many cases are on appeal or the awards, have been reduced, thousands of plaintiffs and their lawyers are still waiting for their day in court.