The People's Perspective on Medicine

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 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.

Rate this article
4.8- 11 ratings
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.” .
Show 1123: What Are the Unexpected Dangers of Medical Devices?
Free - $9.99

The FDA does not require clinical trials before it approves most medical devices. The consequences can be frightening. What should be done?

Show 1123: What Are the Unexpected Dangers of Medical Devices?
  • 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
Join over 150,000 Subscribers at The People's Pharmacy

We're empowering you to make wise decisions about your own health, by providing you with essential health information about both medical and alternative treatment options.

Showing 19 comments
Add your comment

I had the mesh, and now I have to go back into hospital for another operation.

I was scheduled to have the mesh surgery for stress urinary incontinence 5-14-19 but my cousin sent me this article about the FDA pulling the use of mesh for prolapse. When I asked my doctor about it he said the risks were only for prolapse surgery, not for stress urinary incontinence. However, a brochure in his office lists all these risks for the SUI surgery. I’m canceling the surgery because I don’t know what to believe. Was my doctor correct or the brochure?

My mother had a synthetic pelvic mesh inserted due to a proplapse. Less than two years later she was dead from ovarian cancer. I never knew if there was any connection but my mother got sick very shortly thereafter.

I had the mesh hernia repair some years ago and am now experiencing some infrequent pain. I also had a partial hip replacement in 2001, and fortunately have never had a problem, probably since the socket was not replaced.

Mine was done in June, 2015. So far I have not had any problems at all.

I have had surgery with mesh implanted trans-vaginally for stress incontinence in 2000. My sister had the same surgery. Neither one of us has experienced any problems. I am so glad I had the surgery because it worked! My husband has had two inguinal hernia surgeries that the doctor used mesh. He has not experienced any problems. Maybe it depends on the doctor’s experience whether it is successful or not.

Had Stage 2 bladder prolapse. In 2012 had surgery to repair. As far as I know, surgeon sewed bladder to my uterus. Had pain just about daily for five years after surgery. Then it started to subside to some days instead of daily in about sixth year. If I work hard in the house or yard these days, I will usually have some pain that night. If I had it to do over, would not have chosen to have surgery. I am 76 yrs old now.

I had my first transvaginal mesh repair for bladder problems in 2009. Within a year it had torn in half, no longer worked, and eroded into my vagina. I had a second mesh surgery – by a different surgeon – in 2011. The previous mesh is so embedded into my tissues they could not remove all of it. I have had no problems with the newer mesh, though every few years a piece of the old mesh has continued to erode thru and requires another surgery.

I had a hysterectomy done in 2011 because of pain I was having when I worked and had to stretch, like gardening etc.. The mesh was used to hold back the bladder. However, the Dr. who did the stitching up of the peritoneum was very clumsy at sewing apparently as the mesh immediately broke through and was hanging in the vaginal vault. It has taken years to grow enough tissue to cover it, but it isn’t so exposed now. However, the procedure itself did not remove the original problem. I still can’t stretch or garden without severe stomach pain. The Doctor also sewed the vaginal opening so small as to make sexual activity impossible. I should go to another gynecologist to have the opening made larger, but I’m through with Doctors touching me with any more surgery. I really don’t blame the mesh for this problem, just a clumsy hand repair.

I have had 2 hernia surgeries on the same side, with one piece of mesh being put right on top of the other. Now I’m experiencing pain in that area, I was wondering what my options were.

My 2007 surgery mimics Susan’s in Buffalo. I have had no problems with the mesh.

I have a bladder prolapse, IN SPITE OF 1998 SURGERY TO REPAIR stress incontinence. It lasted for about a year, then no did any good. Doctors today tell me it is still in place.

The surgeon’s description of what he did (I had local anesthesia so was awake) was to drill and insert a screw in my spine and tie the loose muscles up to the screw. (I could hear the drill and was curious about what it was).

The incontinence came back after a year, and the POP happened about 15 years after. All they can offer me is the mesh implant, which I refused.

I had extreme prolapse of organs after a difficult birth of my first child, and 2 more births made it worse. In 2001, that mesh was used in a ‘new surgery that only HE knew how to do here.’

It didn’t take long to see that things were going south again and at 82 now, I have quite a belly, but no pain or infection. The mesh has not been legal for 5-6 years, I Thought. A friend’s husband, hernia infected from the mesh, helicoptered to a hospital to save his life. And NOW we’re told it’s not to be used? I thought that was already done, not that it helps me any. None of the births were over 30#. Fingers crossed.

My daughter Debra had the mesh surgery about 15 years ago. I have heard her complain about it ever since. Stomach pain, sex pain, and even her husband said it hurts him during sex. I hope she will tell her doctor again, and maybe something can be done to help her.

I am adding to my previous comment – I see from reading the article referenced (Journal of Women’s Health) above that the mesh installed in me is described as a Xenografic mesh; i.e., it had porcine collegen as part of its composition.
I had looked up the company (Gard Corp, in Georgia) after I had the surgery, and asked for an itemized bill from the hospital. Since that date, Gard has removed any reference to “porcine” material from its description of its product.
Again, I have had no problems with this mesh and have no objection to its composition.

I had surgical mesh (made by Gard Corp) implanted to repair pelvic organ prolapse in 2007, transvaginally. Fortunately, I have had no problems with this mesh at any time. I do recall reading in 2008 about the problems other women were having and asked my doctor about the likelihood of these issues for myself. He assured me there would be no problem, and there hasn’t been.

I had that done to me in 2001 and suffered with terrible pain for almost a year …taking it that long to slowly subside…it still bothers me at times.

As an RN, i saw so many cases of second surgeries to remove mesh that i knew mesh was a problem in the 1990’s. In fact, when a friend had hernia surgery, i advised her not to have mesh. She was told the MD would not be using it. How could the problem go on so long if even I was aware of it.

Thank you for this informmative article.
I notice there is no mention of peristomal hernia repair outcomes. My husband has a large one post his rectal cancer surgery that resulted in his having a permanent colostomy.
There has been a move to use animal product instead of synthetic mesh for hernia repair.
I wondered if there is any information on the success of this product being inserted into humans ? Peristomal hernia repair does not have a high success rate. So glad to read this info prior to pursuing having his repaired.

* Be nice, and don't over share. View comment policy^