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FDA Issues Warnings about Surgical Mesh Used to Treat Pelvic Organ Prolapse & Stress Urinary Incontinence
In 2008, the FDA notified doctors that it had received 1,000 adverse side effect reports about surgical mesh in three years’ time.
“The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain,” it said.
The FDA recommended that doctors undergo surgical mesh training, understand its risks, make sure patients understand those risks, and monitor patients for adverse side effects such as erosion and infection.
On July 13, 2011, the FDA released another alert stating that surgical mesh complications following pelvic organ prolapse surgery were the rule rather than the exception.
After reviewing scientific studies dated 1996 to 2011, the FDA “found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh.” Worse, “Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.”
The agency also added mesh contraction, or shrinkage, to the list of potential complications. This contraction could cause vaginal shortening, tightening, pain, and, thus, the inability to have sex.
In 2012, the FDA ordered surgical mesh manufacturers to study risks and complications of their products with regard to pelvic organ prolapse.
Johnson & Johnson Says It Will Stop Selling Pelvic Mesh
On June 5, 2012, Huffington Post reported that Johnson & Johnson maintained that its pelvic mesh was safe and that it was not recalling those products, but it would stop selling them.
“J&J said it plans to phase out four mesh products over the next three to nine months,” the website stated.
According to the FDA, 10 percent of women with surgical mesh implants suffered erosion within a year of their operation. More than 50 percent of those women were forced to undergo multiple surgeries to have the mesh removed.
“These companies know they will never be able to prove safety and efficacy of these devices in the studies mandated by the FDA in January of this year,” said a woman who has undergone 17 mesh erosion surgeries.
The First Pelvic Mesh Lawsuit Goes to Trial
On April 4, 2014, Bloomberg reported that Johnson & Johnson’s Ethicon unit would have to pay a 64-year-old woman $1.2 million for the injuries and pain she suffered after her surgical mesh eroded and damaged her organs. According to Bloomberg, the company faces more than 12,000 such lawsuits.
The plaintiff told ABC News affiliate WFAA that her mesh felt like a scouring pad. She’s undergone several surgeries to remove it and is back to suffering from incontinence, which is what the mesh was supposed to remedy.
“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” a product liability lawyer stated.
If you have questions about pelvic mesh erosion, attorney Chris Mellino invites you to contact our office for a free consultation. You may also download Chris’ free, easy-to-read guide, Your Ohio Medical Malpractice Questions Answered, read testimonials, or learn about previous case results.
Call (440) 276-3535 to discuss your legal options with one of our pelvic mesh lawyers in Cleveland.