FDA Pulls All Vaginal Mesh Products Off the Market

by Megan Brooks

The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies failed to provide reasonable assurance that the products are safe and effective.

The three vaginal mesh devices available in the United States are Boston Scientific's Uphold LITE and Xenform, and Coloplast's Restorelle DirectFix Anterior. 

The companies have 10 days to submit their plan to withdraw these products from the market.

Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP).

As a result, the agency has taken a series of escalating steps, including reclassifying the devices from class II (moderate risk) to class III (high risk).

As part of this reclassification, the manufacturers were required to submit premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the United States.

In February, the FDA convened an advisory panel to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP.

As reported by Medscape Medical News, the panel recommended that to support a favorable benefit–risk profile, surgical mesh should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh should be comparable to native tissue repair.

The FDA agreed with these recommendations, and because the manufacturers did not provide the required data in their PMAs, the FDA declined to approve them.

"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," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the statement.

The manufacturers are required to continue to follow women already enrolled in their "522" postmarketing studies.

Women who have had transvaginal mesh placed for the surgical repair of POP are advised to continue with annual and other routine check-ups and follow-up care. Women who are satisfied with their surgery and are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider.

Comments

Beth Mast|  Licensed Practical Nurse (LPN/LVN)

Thank you Dr Todd Young for that comprehensive explanation. My family has suffered much at the hands of doctors who prefer methods of “protocol” over patient- specific treatment, leading to extensive misdiagnosis and incredible injury. I have a high regard for physicians who look beyond the obvious and are detail oriented in their approach, and act in unashamed remonstrance of a plan another physician would not alter. I sense you are a physician who not only hears what your patients say...instead you listen to the message behind the words. God bless you!

Dr. Dennis Geyer|  Neurosurgery

"Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider."  After that, contact an attorney.  You may be entitled to "substantial compensation."  It is after all, the American way.

Dr. Asghar Afsari|  Ob/Gyn & Women's Health

Pleased to see that at last FDA, took this action. While I agree that subspecialty matters, I have also observed rejection and other complications due to the use of mesh, performed by the well known, university based/professors. Foreign body for POP management including mid urethral sling had ruined the life of many patients since their introduction.

Using a good judgement in medical care, should out way the propaganda manufactured by the makers.

Dr. J C|  Urology

Just to reiterate: mid urethral sling is not part of this issue at all. Complications are far less.

Beth Mast|  Licensed Practical Nurse (LPN/LVN)

Excuse me. Can I make a suggestion before this becomes one of those comment forums that threatens to negate all positivity from this article? Let the victims speak for themselves. If you’ve never had the “mesh experience,” give ear to those who have. And if you are a physician that is board certified to do surgical mesh placement in women, consider what’s going to be your plan of action since it’s no more legal to place mesh. Above all...please listen to the voice of evidence-based proof that the use of vaginal mesh needs to be abandoned. It took awhile for the FDA to catch on. Maybe one of their top female officers recently had a failed vaginal mesh procedure. Experience is, after all, the best teacher.

Dr. Todd Young|  Urology

@Beth Mast I can agree with your point of view that women with a story of the "mesh experience" need to be listened to.  I am saddened that one of the best products for women has now been removed from the market.  I have used mesh materials for POP for almost 20 years.  I have repaired "train wreck" women who have had mesh placed incorrectly at 'St Elsewhere' by other doctors.  I promise you, the mesh is not the problem but the unbridled manner in which inadequately trained physicians were allowed to use the product WAS a problem.  

I don't think that there was evidence-based proof to ABANDON mesh, as you put it, but rather, LACK of data to show that, in the correct hands, mesh is ABSOLUTELY superior to other methods.  This lack of data is on the device companies.  (looking at you Boston Scientific!) They were more interested in selling their product than to provide safe, effective medicine and people got hurt and were injured.

Again, just like with anything else, in the right hands and in the right patient, mesh was a wonderful product.  I do think that pulling the mesh was the right move because of the lack of oversight of the doctors.  We've just been set back 20 years in time, that's all.

Deborah Rotert|  Other Healthcare Provider

I’m both an RN and a recipient of vaginal mesh. The pain from this has ended my 26 year career, and no longer can I sit to travel or participate in events outside my home because of unrelenting pain. Relations with my husband have ended.

As an OB/GYN nurse, I went to who I thought was the best for my pelvic reconstruction. This physician is well known for removing painful vaginal mesh. How ironic that he placed it in me.

Finally, these products will no longer ruin lives. It takes the FDA a long time to get out of the pockets of the manufacturers. I just wish it would have happened before my life was devastated in 2013.

Dr. Manish Patel|  Urology

Unfortunately those same exact issues arose in women undergoing pelvic floor surgery well prior to surgical mesh.

I’ve treated as nauseum number of women with no mesh with severe issues.

General ob/gyn surgeons are not reconstructive pelvic floor surgeon.

Hospitals know there is a board certification specifically for FPMRS yet they ignore it and allow anyone to perform these complicated procedures so the can bill a operation for their hospital bottom line.

Dr. Shawn Barrong|  Ob/Gyn & Women's Health

It should be clear that this is for pelvic organ prolapse mesh only and does not include mid urethral slings. The mid urethral slings are still the gold standard for SUI with hyper mobile urethra.

Dr. Mike Wolpmann|  Ob/Gyn & Women's Health

@Dr. Shawn Barrong Well said.  The FDA should not do away with the most effective treatment known for SUI, the suburethal sling.  That would be a real tragedy for patients.

Dr. Heather Barbier|  Ob/Gyn & Women's Health

Thank you - I was about to come post the same comment

Dr. Roscoe Marter|  Ob/Gyn & Women's Health

@Dr. Shawn Barrong  Thank you for clarifying.  This was not clear from the article and the Headline is actually misleading.  I agree that the suburethral slings are different in many ways and are considered the gold standard for GSUI for hypermobile urethra.

Claudia Surovjak|  Registered Nurse (RN)
It’s about time! As an OR nurse, I’ve seen many vaginal mesh patients return to the OR for removal after infection, migration and just about every other complication. These poor women have had their vaginas ruined not to mention the pain. I hope this recall eventually includes the mesh used in urethral slings for incontinence. In both cases I think Surgeon education and training plays a large part.

Dr. Manish Patel|  Urology

Stick to your field please. You’re degree and your relative experience is limited. My surgical nurses have a different view. Many of them have MUS or anterior compartment repairs without issue.

The problem lies with hospital credentialing committees allowing untrained physicians who aren’t even board certified in female pelvic medicine. Many implanting surgeons come through a general Ob/gyn practice. You would let s general surgeon do your plastic surgery or cardiac surgery. Why would a generalist be allowed to do reconstruction on a women with providing the board certification?

Surgical privileges are a hospital responsibilities.

Melania Velasquez|  Physician Assistant
Yes, well said!

Dr. Mike Wolpmann|  Ob/Gyn & Women's Health

@Dr. Manish Patel I know generalists that do a fantastic job and have placed far more slings and performed more vaginal reconstruction without problems than any FPMRS in the area.  You are generalizing.  The kits that were placed on the market were bad in poorly trained hands.  Enough said.

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