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Pelvic Mesh Sales Halted by the FDA Due to Safety Concerns

The FDA has finally called a halt to pelvic mesh. It has been used for transvaginal surgical repair of pelvic organ prolapse. What took the FDA so long?

The Food and Drug Administration has just announced that it is ordering an end to the use of synthetic mesh implants for transvaginal surgical repair of pelvic organ prolapse (POP). Synthetic mesh products have been surgically implanted for decades. They are routinely used in hernia repair. Such material helps reinforce the weak part of the abdominal wall. They are also used to “patch” and reinforce surgical repair of POP. In recent years there has been a great deal of controversy surrounding the polypropylene mesh used in such surgery. More than 100,000 women have filed legal claims against the makers of synthetic pelvic mesh.

The History of Pelvic Mesh:

There was a time when surgeons relied upon skill and sutures to repair hernias or prolapse. That’s not to say modern-day surgeons aren’t skilled. They most certainly are. But since about the mid-20th century, synthetic materials have become very popular. Polypropylene mesh took off in the 1960s. By the 1990s vaginal mesh kits were available for urogynecologic surgery. 

The reason mesh implants became so popular was that the old-fashioned hernia repairs did not always last. Recurrences led surgeons to embrace synthetic mesh. It was supposed to make abdominal repairs more successful. That was also the impetus behind the use of mesh in POP surgery.

Some experts believe that the true risk of recurrences with standard surgery were far less than the mesh enthusiasts suggested (International Journal of Women’s Health, April 1, 2015). The author of this fascinating article points out that there are a number of serious risks associated with transvaginal mesh surgery. More about that shortly. First, a bit of an overview.

Hernias and Prolapse:

When the abdominal wall develops a weak spot or a hole, the intestines can slide into that space. There are several different hernias. An inguinal hernia occurs in the area of the inner groin. If you see a bulge on one side of your pubic bone, chances are good you have an inguinal hernia. Coughing or straining often makes it worse. The FDA estimates that there are 800,000 operations to repair inguinal hernias each year.

An umbilical hernia occurs around the belly button. A hiatal hernia, which can’t be readily be seen externally, occurs at the level of diaphragm. The upper part of the stomach may slide through this weakened area.

Prolapse occurs when the uterus, bladder or rectum protrude into the vagina. As mentioned above, doctors call this POP (pelvic organ prolapse). Childbirth can impact muscles in the pelvic floor and weaken support around the vagina. Over the last couple of decades, synthetic mesh has been used to facilitate the surgical repair of prolapse. When this procedure is done through the vagina, it is called transvaginal repair of POP.

The Problems with Pelvic Mesh:

On April 16, 2019, the FDA:

“ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately.”

“The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices…”

“‘In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,’ said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.”

Part of the reason for FDA’s action against MESH was:

“…a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.”

The FDA Moves Slowly:

The author of the article published in the International Journal of Women’s Health, April 1, 2015, points out that:

“Despite initially reassuring data, concerns regarding the safety of transvaginal meshes arose in 2008 with the first FDA notification that it had received more than 1,000 reports of mesh associated complications, some of which may not be correctable surgically (US FDA, March 9 available at www.fda.gov). In 2011, the FDA released two more communications highlighting safety concerns surrounding meshes. The update stated that there were 1,503 reported complications associated with mesh devices for POP from 2008 to 2010. The most common complications included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia [painful intercourse], organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuromuscular problems, vaginal scarring with shrinkage, and emotional distress. Many of these complications required further surgical intervention.”

Please note that it took the FDA more than a decade to pull the plug on vaginal mesh even though there were clear warning signals.

The FDA’s Advice About What to Do Now:

The FDA encourages women who have had pelvic mesh implants to have regular checkups and notify their health professionals promptly if they experience pelvic or groin pain, persistent bleeding or pain during sex. If prolapse surgery becomes necessary, the agency advises women to seek non-mesh treatment options.

Critics of the FDA have challenged the agency on its regulation of surgical mesh products. In fact, there is general concern about the way the FDA handles medical devices in general. That ranges from artificial hips to implanted heart defibrillators. 

You can listen to a powerful interview we conducted with Jeanne Lenzer, author of “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.” Here is a link to the FREE podcast of Show 1123: What Are the Unexpected Dangers of Medical Devices. You can also stream the audio from our website by clicking on the green arrow under the title of the show.

Share Your Story:

Have you had pelvic mesh implanted? If so, how did it go? What about other devices? Please let us know about your experience (good or bad) in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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  • Dallenbach, P., "To mesh or not to mesh: a review of pelvic organ reconstructive surgery," International Journal of Women's Health, April 1, 2015, doi: 10.2147/IJWH.S71236
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