February 17, 2014 FiDA highlight added The Gazette
A 2005 surgery meant to correct Frances Schulte’s (from Coralville, Iowa) urinary incontinence brought her pain and further embarrassment rather than relief.
Doctors implanted a medical device known as surgical mesh, which has since eroded — which means her mesh sling is poking and irritating nearby organs.
“I get stabbed thousands of times a day,” Schulte said. “People don’t understand that I’m in pain every day.”
Schulte, whose surgery was done in Illinois, said that the pain prevents her from comfortably moving around and going to the bathroom.
Surgical mesh, which is generally used to repair weakened or damaged tissue, is made from synthetic material. It is permanently implanted to reinforce a weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, which can commonly occur in older women, women who have had children and women who are obese.
However, more than 1,000 adverse events were reported to the U.S. Federal Drug Administration between 2005 and 2007, which caused the agency to issue a Public Health Notification in 2008. Since then, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse.
The most common complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, organ perforation and urinary problems.
“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” the FDA states on its website.
The FDA has stated that complications associated with the use of surgical mesh have not been linked to a single brand. But Schulte, along with thousands of other women nationwide, opted to seek legal action.
Multiple class-action lawsuits have been filed against various makers of the mesh. Cases against Johnson & Johnson, C.R. Bard, Endo Health Solutions Inc. and Boston Scientific Corp. are all winding their way through federal court in the Southern District of West Virginia.
“I don’t like that they’re still putting it (the mesh) into people,” Schulte said.
Less risky alternatives
Dr. Catherine Bradley, an OB/GYN and division director of urogynecology and reconstructive pelvic surgery at the University of Iowa Hospitals and Clinics, said that a polypropylene mesh sling was first introduced to the United States in 1998. It was developed by Scandinavian researchers and was tested with promising results.
As the medical device became more popular, other companies began developing similar products, Bradley said.
“I don’t think these were tested as much as they should have been, and the FDA approval was probably inadequate,” she said.
She added that she never used transvaginal mesh for her patients because she was uncomfortable with the studies that had been completed.
Bradley noted that the FDA since has required companies making these products to do more rigorous testing, which can be expensive — this, combined with the class-action lawsuits, has led to some companies to no longer sell the product.
Instead, she opts to treat women suffering from pelvic organ prolapse through surgery without mesh in less severe cases and, when necessary by sacral colpopexy, a less-invasive surgery in which mesh is added through an incision made in the abdomen.
Bradley said there is only about a 5 percent risk of erosion when mesh is implanted this way, compared with a 10 percent and sometimes higher risk of erosion when mesh is applied transvaginally. Removing eroded mesh is difficult, but the removal can help with the pain.
“With abdominal surgery, you are also less likely to have pain than a transvaginal surgery, even one without mesh,” she said.
“As a surgeon who treats women and uses mesh, we complain about how much time we spend talking about it,” she said. “But it’s better that we’re spending more time talking with patients and counseling patients that we can’t always cure (their problems) without complications arising.”