I keep hearing about doctors telling patients they don’t use “the bad mesh”… or that “the bad mesh was recalled”.
Many are saying their doctor only uses “the good mesh”. Well?? What exactly are the “good” or “bad” meshes?
That is a good question! Let’s talk about mesh recalls, and lawsuits, and complications (oh my!).
What About Mesh Recalls?
“Neither the FDA nor device manufacturers recalled many transvaginal mesh products, which are used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Some manufacturers simply stopped selling their products after women filed lawsuits.
In January 2012, the FDA issued postmarket surveillance study orders – called 522 orders– to all manufacturers of urogynecologic surgical mesh products. After the FDA issued the orders, some mesh manufacturers quietly withdrew their products from the market.
These actions by the FDA came after women nationwide experienced post-surgery complications ranging from severe bleeding and infection to reports of the synthetic mesh cutting through the vaginal walls and eroding into nearby organs. Consumer advocates and some experts in law and medicine are pushing for these medical devices to be recalled and banned. Many also demand new legislation to prevent injury to more women in the future.
Problems with mesh led to thousands of lawsuits filed against manufacturers, and some of the companies withdrew their products from the market or issued voluntary recalls.”
The first products to go off the market were:
- Boston Scientific’s ProteGen Sling in 1999.
- The ObTape by Mentor was removed from the market in 2006
- “Boston Scientific Recalls ProtoGen Mesh
Boston Scientific’s ProtoGen was the first transvaginal mesh product on the market and the first to be recalled. The company voluntarily pulled the product in 1999 amid safety concerns, just three years after it launched.Within a year of ProteGen being released, other manufacturers created their own transvaginal mesh products. Because of the similarities between these products and ProteGen, all of them bypassed stringent clearance requirements by utilizing the U.S. Food and Drug Administration’s 510(k) clearance system, which allows medical manufacturers to sidestep human testing and deliver a product directly to the market as long as it is similar to an already approved product.
- Mentor Corporation’s ObTape
Mentor Corporation’s ObTape Vaginal Sling is a piece of mesh called a bladder sling used to treat incontinence in women. It was implanted between 2003 and 2006.About 35,000 women received the implant. One of the biggest problems with this product was a high rate of vaginal erosion, and many doctors discontinued use of the product. Experts claimed the product was too dense and did not allow capillaries and tissue to grow through it, causing the body to reject it.”
Then, more companies voluntarily pulled some of their own mesh products in 2012.
Ethicon Pulls Mesh Products
In June 2012, Johnson & Johnson’s Ethicon unit stopped selling four of its Gynecare mesh products after more than 600 women filed lawsuits against the mesh manufacturer.
The following products were discontinued:
Gynecare Prolift Kit
Gynecare Prolift + M Kit
Gynecare TVT Secur
Gynecare Prosima Pelvic Floor Repair System Kit
While the company stopped selling these products worldwide, it is not recalling mesh that was already sold or implanted. Ethicon continues to sell Gynecare Gynemesh, but changed the labeling to restrict its use to abdominal implantation.
A spokesperson for Ethicon, Matthew Johnson, denied that the decision was based on safety concerns. He told Bloomberg, “We continue to have confidence in the safety and efficacy of these products.”
C.R. Bard Stops Selling Some Mesh Products
Approved by the FDA in 2008, the Avaulta Plus was designed to treat pelvic floor disorders and incontinence. On July 1, 2012, C.R. Bard Inc. stopped selling its Avaulta Plus mesh product.
One of the first transvaginal mesh jury verdicts came after Christine Scott sued C.R. Bard over her Avaulta mesh implant. She had eight surgeries after the mesh cut through her colon and caused other problems. Scott was awarded $5.5 million, including $500,000 awarded to her husband because the product ruined the couple’s sex life.
The same article goes on to say:
The FDA and Mesh Recalls
When the FDA’s advisory committee convened on this topic in September 2011, the 15-person panel was met by frustrated medical professionals who witnessed the damage caused by the mesh firsthand. The panel refused to recommend a recall, but is considering reclassifying transvaginal mesh as a Class III device, which would require stringent premarket testing before widespread distribution.
It’s unclear what the FDA will do next. The agency usually follows its advisory committee recommendations and has ordered dozens of mesh manufacturers to conduct safety reviews of their products. Even with that, legal and governmental spotlights on transvaginal mesh may force the FDA to take a harder stance.
Doctors are also weighing in on possible mesh bans. The American Urogynecologic Society (AUGS) disagrees that mesh should be banned.
Consumer Advocacy Group Calls for Mesh Ban
Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, urged the FDA’s advisory committee to recommend a recall of the device. According to the group, mesh poses significant risks to the public. Public Citizen petitioned the FDA to ban the device in 2011.
The group pointed to the lack of testing before mesh implants were released to the public and urged the FDA to require testing on mesh products – including testing on humans.
“Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable,” Carome said. He also believes surgical mesh needlessly exposes women to serious, life-altering risks.
So, while I think it would be NICE if they actually DID recall and/or ban these products, currently, that is not the situation. They are leaving it up to the manufacturers, doctors and patients to sort it all out. Not such an easy feat – obviously – as complications and lawsuits continue to rise. Speaking of which…
Complications and Lawsuits are NOT just for “no longer in use” Mesh
Unfortunately, it’s not just the mesh products that were taken off the market that are causing all the problems.
There are now six different manufacturers, that now have over 100,000 lawsuits against them collectively, for a wide wide variety of different mesh products. Most people are not suing doctors, but rather the attorneys are going after the manufacturers.
These manufacturers include:
- American Medical Systems
- Boston Scientific
- C.R. Bard
- Johnson & Johnson’s Ethicon
- Coloplast Corp
- Cook Medical
This article from MDND, 100-Thousand Mesh Defective Product Cases Now Filed as Mesh Makers Assure Shareholders, from in 2014 stated:
“Mesh News Desk has done the math and the numbers of pelvic mesh lawsuits just keeps rising.Including the numbers from the mesh makers latest Securities and Exchange Filings with the federal government, the number of defective mesh cases now hovers at the 100-thousand lawsuit mark.
Even with 67,322 cases filed in federal court in West Virginia, more than any other Mass Tort amassed in one court, the media coverage remains quiet with the exception of large jury verdicts.
The latest numbers come from the SEC 10-Q report filed by Boston Scientific (23,000), Johnson & Johnson (33,000), AMS/Endo (25,000) and C.R. Bard (12,445). Add those number to the number of cases filed by Cook Medical, a privately held U.S. company which is facing 330 cases filed in the federal court in West Virginia and an unknown number around the country; Coloplast, a Danish company, facing at least 1,777 actions filed in the MDL; and Neomedic, a mesh maker from the U.K., which has 72 federal cases filed in federal court in the U.S.
These numbers do not include the cases filed with the MDL over the last two months and recently added to state courts. Typically, the federal multidistrict litigation has been adding one to two-thousand product liability pelvic mesh lawsuits per month.”
There is also this attorney website (who I do NOT know or have any affiliation with) has a list of “Transvaginal Mesh Lawsuits“, including verdicts and settlements, as well as upcoming trials, and includes this lastest info:
$100 Million Jury Verdict Against Boston Scientific
$100 Million was awarded to the plaintiffs in Deborah Barba v. Boston Scientific by a Delaware jury on May 28, 2015. One of the implants, Pinnacle mesh for pelvic prolapse has been removed from the medical device market, while the Advantage Fit sling is still being sold and implanted. Ms. Barba had additional surgeries to revise the medical devices, but the implants were unable to be completely removed resulting in pain and injuries. The jury awarded $25 million in compensatory damages and $75 million in punitives.
As of May 28, 2015, transvaginal mesh plaintiffs have won twelve (12) trials for sixteen (16) transvaginal mesh plaintiffs and the defendants have won three (3). Judge Goodwin has ordered all designated TVM defense and plaintiffs’ counsel to appear before him in chambers on June 2, 2015. Following the failed February 5th, 2015 judicially ordered status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million, three trial settlements and numerous confidential settlements.
– See more at: http://www.carolynstclair.com/practice-areas/transvaginal-mesh
And, that 100,000 figure is just the number of lawsuits!
This does not include all the reported complications that do NOT have lawsuits. Let alone all those that go unreported.
The FDA doesn’t make it easy for patients to report a complication, and it’s not mandatory for doctors to do so. So, if you have had complications, please do try to file a report: This article, also from MDND, explains how: http://tinyurl.com/opuvs6e.
Many people, I’m sure, do not even know the problems they are having are mesh related, because many doctors are not recognizing it, until they have to. Which is often when the mesh is visibly coming through the patients vaginal wall, or something undeniable like that (“yep, that’s mesh alright!!”). Initially, though, many are told “it is NOT the mesh”, and later told “you’re the ONLY one!“. Even once they do recognize it, there’s often not much they can do about it.
Complications and Lawsuits are also NOT just for for Mesh used for POP (Pelvic Organ Prolapse)
There is also lot of misinformation out there, leading people to believe that it is only the mesh used for POP (Pelvic Organ Prolapse) that is causing problems, and not the mesh/tapes used for SUI (Stress Urinary Incontinence). The July 2011 FDA warning (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm) does, in fact, say that the warning is geared towards POP mesh. However, it ALSO mentions a lot of statistics about problems from mesh for SUI – such as almost as many reported complications for SUI (1371) as there were for POP complications (1503). Still, they specifically said their warning pertained to POP mesh, and stated they would get back to us on the SUI mesh. Then, in March 2013, the FDA basically dropped the ball on mesh for SUI, letting the issue slide by putting out some very vague updates regarding SUI mesh, and not requiring the same mandatory studies as they were demanding for POP mesh.
They are somehow getting away with saying that it is “Okay to Use Mesh For SUI, but Too Risky for POP”, when in fact, thousands of the lawsuits you see all over the TV, and reported complications, are for mesh that was used for SUI. Even the newest mini-slings for SUI are causing complications.
Are the Benefits Worth the Risks??
From what I can tell, mesh and the percentage of associated risks are all VERY much up in the air. There’s a lot of conflicting research going on, often by bias parties. There’s not a lot of conclusive data, especially not long-term data. The question of what defines “successful surgery” or “manageable;e complications” also comes into play.
We know mesh is “NOT inert, but instead it hardens into a window-screen like consistency, and then can start eroding/cutting through tissues, nerves, organs, etc. These are NOT minor issues… and there are NOT easy fixes.
We also know that complications are “not rare”.
Many will say mesh repairs will last longer than non-mesh repairs. While it’s true that mesh was designed to be more durable than native tissue, and that was the hope, this has not been proven, and is not what they are finding as fact.
In fact, the FDA states the OPPOSITE:
“The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.”
And, please note that the FDA warnings do not mention specific brands or types of mesh.
I do know, all too well, that those that have (not rare) mesh complications often need multiple surgeries to try to remove it, and repair damages done. Unfortunately, many who have mesh issues do not get better and wind up with much more serious issues then they started with. It’s truly sad. Especially when they were not even offered alternatives or given all the facts. Even those who are not having any problems, and are now happy with their mesh – could very well have mesh complications years down the road. I hope not. I really do… but, nobody really knows.
It is still difficult for me to believe this continues to be allowed to go on. I truly believe it’s about $$, and not about patient care. I feel like people are being used as human guinea pigs for products that should never have even been allowed on the market in the first place and were never actually tested properly FIRST. Why is this ok?? The 510K process that allowed these products to be on the market in the first place is seriously flawed. (For a more detailed look at how all this happened, watch THIS VIDEO, and also see, “The FDA HAS BEEN FUMBLING FOR DECADES: RESULTING IN THOUSANDS BEING INJURED!“. Amazing, really.)
We don’t allow this in other areas. If a car is found to have a faulty part on it, they will recall all those cars in an effort to make sure people are safe. Yet, when it comes to medical devices, it’s okay to test out KNOWN high-risk products on the general public?
So many who have mesh implanted are NOT told all the facts. They are often NOT given other options. Many doctors downplay the risks, or simply don’t have the correct information. There is way too much WRONG information given out… or no information at all.
Wait. So, which is the “GOOD” mesh??
Well, it’s not that easy to figure out, is it? There is a lot of controversy over what exactly is “good” mesh.
Some docs are saying it’s the “older” mesh products that work best. Some say it’s the “newer” ones. Maybe it’s the size of the holes in the mesh? Maybe they don’t even use mesh, they use “tape”. I’ve heard that some Canadian doctors told folks that it was only the mesh in USA that is the problem. Some say, it’s only mesh used for POP, or vaginally placed mesh that’s the issue.
They keep coming out with new types, that they say are better – but, they are still made of the same material – polypropylene. Even the newest SIM mini-slings are causing issues (http://tinyurl.com/o8p6lax). There are a lot of myths vs. facts.
But, here’s a good fact to know:
FACT: MOST of the mesh products, that have the reported complications and/or lawsuits against them, are STILL on the market and being used regularly today.
So, there’s no short list of the “bad” meshes that were already pulled off the market. Instead, there’s too many for me to list here that DO have lawsuits against them, and the numbers keep growing. I had an AMS Monarc sling implanted in 2012, which I was shocked to later discover was one of the mesh products that has tons of lawsuits… and reported complications… from before and after 2012. It is still being marketed & implanted today. (See #2 on the Top 10 post.)
Anyone can search the FDA Maude database for reported complications. I’m sure not too many bother to do so until AFTER they have issues – but, I would recommend finding out exactly what kind of mesh your doc thinks is the “good mesh” and check there for starters. It’s at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm.
I would also ask around in the public support groups that are open to all. Groups like the Mesh Problems group ( https://www.facebook.com/groups/meshproblems), have a lot of good information in their files, and will also allow you to ask questions and interact.
Personally, I do not think any of it is “Good Mesh”
I have heard, first-hand, far too many horror stories, and learned too much. This includes testimonies, and desperate cries for help, from people who have had all kinds of mesh complications. This is regardless if they had mesh implanted for POP, SUI, or Hernia repairs, or if it was placed vaginally or through the abdomen. I have heard from people of all ages, and sizes, who went to Gynecologists, Urologists, and yes – even UroGynecologists who were very well-respected and known doctors for their mesh implants – yet these people still had major complications (please see #7 on the Top 10 post.) So many lives of patients, as well as their spouses and children’s lives, are often completely devastated and changed forever when they wind up disabled, bed-ridden, more . Mesh, is the implanted gift that keeps on giving. It’s heartbreaking. It is NOT manageable.
Don’t believe me? You don’t have to. Go check out the “Patient Profiles” on MDND’s website… or go to the public “Mesh Problems” group, or one of the many other blogs and websites popping up from those with mesh complications.
So, no, I do not think it’s worth the risks involved. Even if it works for some. I think most of them, if not all, could be helped just as well withOUT mesh, without the ADDED risks of mesh.
I think if you talk to any one of the thousands of people who are experiencing first-hand mesh complications, they will back me on this. It would be different, I suppose, if there were just a few of us – a few “freak accidents”, if you will. I would actually prefer that were true. I would sleep better at night. But that is not the case. The risks of becoming one of us – the mesh-injured – are “not rare” and too high, should you choose mesh.
- Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI: https://meshmenot.wordpress.com/top-10-things-to-know-about-mesh-before-surgery-for-pop-sui/
- Is it Just Transvaginal Mesh Causing Problems?: https://meshmenot.wordpress.com/2015/05/30/is-it-just-transvaginal-mesh-causing-problems
- FDA warns there is NO evidence that mesh provided any greater clinical benefit than non-mesh surgeries: https://meshmenot.wordpress.com/2015/04/02/fda-warns-there-is-no-evidence-that-mesh-provided-any-greater-clinical-benefit-than-non-mesh-surgeries/
- Does the FDA say that mesh tapes for SUI are safe and SHOULD be used?: https://meshmenot.wordpress.com/2015/03/11/does-the-fda-say-that-mesh-tapes-for-sui-are-safe-and-should-be-used/
- Top 10 Myths Woman are Told Today about Pelvic Mesh: https://meshmenot.wordpress.com/2015/01/05/top-10-myths-woman-are-told-today-about-pelvic-mesh/
- It’s NOT enough. We need help! https://meshmenot.wordpress.com/2015/01/05/help/
- Mesh Problems: An OPEN/PUBLIC group, where anyone can ask questions and get information on mesh: https://www.facebook.com/groups/meshproblems/
- Links to many other articles, blogs, support groups, and resources on the bottom of this blog
Perhaps even more helpful than articles, is talking to a variety of others who are suffering from mesh complications, and are in various stages of treatment. Three of the larger support groups I found helpful are:
- Women’s POP/SUI TVMesh Complications Support (Closed Group)
- Fighters And Survivors of All Transvaginal Mesh And Hernia Mesh/Plugs (Closed Group)
- Mesh Problems (PUBLIC/OPEN TO ALL, including doctors, etc)
- More resources listed on the footer/main page of this blog!