Reporters Resource on Covering Pelvic Mesh Issues

//Reporters Resource on Covering Pelvic Mesh Issues

Reporters Resource on Covering Pelvic Mesh Issues

Mesh 101: The Basics

For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research.

This is not a lawyer-generated story!  There are real women suffering devastating injuries from the use of plastic mesh and it continues today! 100,000 product liability lawsuits concerning transvaginal mesh makes it larger than Vioxx, breast implants and Phen-Fen all in one! Please feel free to share this information with any reporters you know.


“We were very shocked and the number of women who contacted us after the story with very similar stories of chronic pain that began shortly after surgery.”

~ Avis Favaro, Medical Correspondent, CTV National News, Ontario, Canada September, 2012

 edited mesh poster leaving out kathyPutting a Face on Adverse Events

This story has the potential to eclipse Vioxx, silicone breast implants and thalidomide combined IMHO!  There are 104,000 lawsuits consolidated in one federal court in what’s called multidistrict litigation, similar to a class action, as well as hundreds of cases filed in state courts around the U.S. and globally.

I’m a reporter who started looking at these issues in 2009 and could not believe what I found – the perfect storm of aggressive marketers, the doctors who are their audience, and an FDA that is largely hands-off when it comes to regulating medical devices, unlike the more stringent approval pharmaceuticals must undergo.

Injured women are told the pain is “in their head” and sent to pain management or prescribed antidepressants. There are few doctors who can do complete mesh removals or who even recognize the symptoms of mesh erosion, nerve entrapment, or the systemic effects of mesh, a permanent implant. Contrast that with the numerous implant doctors. Mesh manufacturers trained anyone who was interested in increasing revenue to their practice, in weekend cadaver clinics, despite the fact that many doctors did not have adequate surgical skills.

“It is just so unbelievable that a “minor problem” outpatient procedure that is minimally invasive causes life changing results. I know my life as I knew it is gone.”~ mesh injured patient

Reporters are amazed at the number of responses the vaginal mesh stories generate. Women who had been told they were the only one, suddenly realize their symptoms are being experienced by other women.

As a reporter you will hear stories you did not know could exist in modern medicine with few avenues for relief by those who are suffering. Men are suffering too from the same plastic mesh used in hernia repair.

Here is a guide on covering the story.

Why is it Used? 

Transvaginal mesh means it is placed through the vagina. This procedure called “minimally invasive” and it’s done to suspend pelvic organs that may prolapse through the vagina, a fairly common condition in women as they age, after multiple vaginal births, due to a hysterectomy,  as a result of surgery or due to weak collagen. Pelvic organ prolapse is known as POP.

Many different organs can prolapse in a woman and they include:

Urethrocele– lower vaginal wall and urethra;

Cystocele-upper vaginal wall and bladder;

Uterovaginal – uterus, cervix and upper vagina;

Rectocele– lower posterior vaginal wall and rectum;

Enterocele – upper posterior vaginal wall and small bowel. POP is measured in four stages from zero to 4.

Page four and five of this FDA page shows the female anatomy and what can go wrong.

These are embarrassing conditions many women do not want to talk about. That’s why I called my original series “Suffering in Silence.” The four-part series from 2009 begins here.

Mesh is also implanted in women following a hysterectomy, sometimes prophylactically to prevent a possible future prolapse.

Another condition treated with mesh is stress urinary incontinence (SUI) which occurs when urine leaks during physical activity, coughing, sneezing or laughing. It’s estimated about 13 million American women experience SUI.

It’s estimated upward of 60 percent of women will suffer from one or both of these conditions in their lifetime and the FDA reports that in 2010 about 300,000 women had surgery to repair POP with about 3 out of 4 done transvaginally. Market data also shows that 80 percent of the 260,000 SUI surgeries done in 2010 were done transvaginally with mesh. (FDA White Paper- see below)

Transvaginal or abdominally-placed mesh for POP or SUI is intended to be a permanent implant.

One criticism of mesh often heard is that implanting it transvaginally is a “clean-contaminated” field that introduces bacteria which violates surgical protocol. An early warning about mesh came from Dr. Donald Ostergard who said mesh is not inert and reacts within the body.

See his work here:

Contraction of mesh, scarring, foreign body response, implantation of mesh in areas with ligaments, muscles and nerves continues to incite chronic pain. Many implants cannot be removed, especially the larger POP meshes with arms embedded deeply into tissues.  As a result, most of these women cannot work, they lose their livelihood, their homes and their husbands.

“I’m getting booted out of my home to. and I still have at least one or more surgeries left. I pray and pray, I just hope someday this pain will not be with me anymore. I lost my husband during the middle of this, and I know this played on his death, because of his worry for me.”


What is Surgical Mesh?           

Today’s mesh is generally made from polypropylene, a petroleum-based product, or is a composite of pig or cadaver biologic material.

Polypropylene is derived from petroleum and was developed in the 1950s as a thermoplastic polymer resin that can be molded into many forms. Mesh manufacturers molded the plastic into fibers for sutures. Polypropylene knitted mesh using monofilament yarns make textile fabrics and indoor-outdoor rugs.

Nine manufacturers make vaginal mesh including  Johnson & Johnson (Ethicon, GYNECARE), C.R. Bard, American Medical Systems, Boston Scientific, Endo Pharmaceutical Holdings, and Covidien, among others.

Before synthetic mesh was used to hold up pelvic organs, doctors were trained to stitch up the falling organs. The main complication from this procedure is a return of the condition, but many women have been complication-free for many decades. Doctors also fashioned a sling or hammock from a woman’s ligaments, often from her leg, which provided the perfect biocompatible natural support for sagging pelvic organs.

Synthetic mesh was first used for hernia repair in the 1950s but sometime in the 1990s it began to be used for POP and SUI.  By 1996 the FDA cleared the first surgical mesh product for use in SUI and in 2002 for use in POP. The introduction of pre-cut “kits” corresponded with weekend cadaver training sessions offered by mesh manufacturers.

Gynecologists, often not trained surgeons, were schooled by the manufacturers how to implant the plastic mesh with the aid of a kit including pre-cut mesh, needles and sutures.

Almost immediately complications were noted. From 2005 to 2008, the U.S. Food and Drug Administration noted it had received more than 1,000 reports of complications associated with mesh.

They can include:

  • Erosion through the vaginal epithelium and tissues;
  • Infection;
  • Perforation of bladder, rectum,
  • Urinary problems;
  • Internal bleeding;
  • Recurrence of prolapse and/or incontinence;
  • Vaginal wall narrowing
  • Nerve entrapment
  • Vaginal scarring;
  • Dyspareunia (painful sexual intercourse)
  • Death“I’m so tired from the struggle & the wait for proper medical attention. My heart is growing weary after five years I am getting worse & scream out to even get up & set down . The getting up is worse , I draw double holding my lower abdominal area where there is an open hole that bleeds.”

By October 2008 when the FDA issued a Public Health Notification (PHN) concerning transvaginal mesh, it said there were more than 1,000 reports of adverse events, as the FDA calls complications. The events were serious but “rare,” according to the FDA. FDA 2008 Public Health Notification here.

Then in July 2011, the FDA (here) reported that complications associated with transvaginal mesh to treat POP increased five-fold; that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and that transvaginal mesh used for POP repair “does not improve symptomatic results or quality of life over traditional non-mesh repair.”

The FDA issued a White Paper “Urogynecologic Surgical Mesh” about the same time which is an excellent resource here.

It was after this point that lawsuits began to be filed.

The Problems: A Safety Loophole

A little known loophole buried deep within the administrative jargon of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is called the 510(k) process. The process is used to fast-track the marketing of low to moderate risk medical devices such as wheelchairs, tongue depressors, latex gloves, Class II devices such as catheter, blood glucose monitors and surgical mesh.

No pre-market review is required for approximately 3,000 medical devices approved by the CDRH every year. That means no clinical trials must be presented to assure safety and efficacy unlike the pre-market approval (PMA) process pharmaceuticals must undergo.

Unfortunately with the explosion of medical devices, permanent implantable and high-risk devices are also approved via 510(k). All the  device maker must do is name a “predicate device” currently being sold that the new device resembles.

The “substantial equivalent” standard has allowed thousands of medical devices to flood the market with no clinical trials.

DePuy metal-on-metal hips, defibrillators, pacemakers, synthetic transvaginal mesh and hernia mesh are all approved via 510(k). Last year, the Institute of Medicine (here) called 510(k) “fatally flawed” and called for the outdated process to be abolished.

The FDA discussed the IOM report in a September 2011 meeting. The transcript is here:

The recalled ProteGen Sling has served as a predicate device for most of the meshes on the market today. A great resource on the ProteGen predicate was done by a mesh injured woman who I’ve found to be very credible and an excellent researcher. It appeared on iCNN here:

See Diana Zuckerman from the Center for Women and Families, and her excellent piece on 510(k) published in the Archives of Internal Medicine here.

The FDA has a limited budget to conduct medical device reviews as it receives much of its funding from Congress. Some of our representatives feel strongly about the “constituents,” namely the medical device industry, especially in states that have a thriving medical device industry.

The Problems: Recalls

Even today women are often told the bad mesh is off the market. In most cases this is misleading because the vast majority of meshes are still on the market.

In June 2012, Ethicon (Johnson & Johnson) announced it was discontinuing the sale of four synthetic transvaginal meshes from its Gynecare division.  Here is background story from Mesh Medical Device News Desk.

Further evidence the FDA bends to the wishes of industry – The Food and Drug Administration Modernization Act of 1997 narrowed the array of issues that the FDA may consider in a 510(k) review, and directed the FDA to limit, to the “least burdensome” level, the scientific evidence requested to determine substantial equivalence of devices that involved new technologies. That means least burdensome to industry, not to the patient who might be adversely impacted by a defective medical  device.

In 2012, Rep. Ed Markey (D-MA) tried to close that loophole with his Sound Devices Act, which would not allow a recalled medical device to serve as a predicate. The Sound Devices Act, supported by Consumers Union, was overwhelmingly defeated by a congressional committee.

Here is a Bloomberg story on using predicates to approve new meshes.

The FDA did attempt to play a little catch up in January 2012 when it ordered about 35 mesh manufacturers to do three years of complication follow-ups on women who have been implanted with mesh.  These are called 522 studies and the FDA has limited authority to order the studies when a medical device appears to be injuring patients.  At this writing, more than three years later, those 522 studies are in limbo and have not been completed.

The Problems: No one is Watching

No one.

There is no national medical device registry in the U.S. Essentially your automobile’s VIN # is a better example of how an industry can follow-up when there is a problem. That system does not exist for medical devices at the present time and in the U.S. no one is gathering data at the present time on medical devices when they fail to perform as intended.

Australia has a form of  post-market surveillance and it’s no surprise that that country was the first to understand that DePuy (Johnson & Johnson) metal-on-metal ASR hip implant was failing because of the many reports coming in. DePuy ASR was later recalled but not before thousands more patients received the implant.


The Problems: No Idea of the Scope of Injuries or Complication Rate

This is another mystery.

The FDA reported in July 2011 that from Jan. 01, 2008 through Dec. 31, 2010, it received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.

But reporting an adverse event by the manufacturer is largely voluntary as the manufacturer can decide if the injury is mesh-related or not. The MAUDE database within the FDA (Manufacturer and User Facility Device Experience)  is where a woman or her doctor are supposed to report complications. The actual reported number are thought to represent  about 1 percent of real life injuries, according to a government report. That’s because the database is little known, and difficult for a patient to navigate.

Here is a MDND story on How to Report an Adverse Event:


(Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:

1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)

2.) Brand Name: Tension Free

3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.

4.) Records Per Report Page: Change to 500 and click Search.”

Without tracking and with few finding the FDA’s MAUDE database and entering their device numbers, there is no way to really know how many women are really suffering complications from transvaginal mesh.

The Problems: How Women are Treated

POP and SUI are considered “conditions” and are an inconvenience, generally not painful, but are embarrassing. Most women do not talk about the condition and many find it embarrassing even to talk about complications that result from surgery.

That may be one reason the surgery option continues today; women are embarrassed to speak to their doctor about complications; symptoms may be general in nature and they may not associate the symptoms with mesh; and doctors who receive their primary education from the mesh makers and their representatives, are not equipped in the majority of cases to handle complications.

Women suffering after a mesh implant often hear, “you’re the only one who is having these problems.” Women suffering complications are frequently told they are depressed and told to visit pain management and to take antidepressants. Many women talk of suicide. Some wish they would get cancer, at least it would be a confirmed medical condition.

These stories are repeated over and over.  #




By |2017-09-15T23:22:02+00:00June 21st, 2016|Mesh Reading Room Resource|27 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Caitlyn August 31, 2012 at 5:02 am - Reply

    Hi Jane

    In Britain there is no national registry for mesh implants. The system for reporting adverse events is voluntary the same as the MAUDE database. I think there may be one for hips but that is all. Most doctors do not report adverse events and it is a difficult system to navigate too requiring device model no. and serial no etc.

    Following the recent PiP breast implant scandal, the Royal College of Surgeons has called for a national database for all implants but this has not been implemented and there are no signs it will be implemented any time soon if at all.

    At least the FDA has issued warnings about mesh because in Britain the response by our regulatory authorities, the MHRA, has been very weak. They will not acknowledge the extent of problems because they rely on their voluntary reporting system at present. Figures on pariamentary record, published thanks to Teresa Hughes from Meshies United, show the removal surgeries nearing 5% of total number of TVTs carried out annually.

    In Britain, we cannot even get information about the approval of mesh products – it is not available to the public. We do not even know on what grounds the mesh device has been approved and what clinical trials, if any, it went through to gain approval. Devices are approved by one of 70 different bodies in Europem the quality of which may vary wildly and the process is supposed to be monitored by the MHRA. The MHRA do not seem to have a handle on the situation and are not monitoring the approval of these devices adequately. Our system is not transparent unlike your FDA system (which admittedly is also flawed),


    • Jane Akre September 4, 2012 at 3:22 pm - Reply

      Postmarket Surveillance and medical devices in the UK.

      Some clarification is found here:

      • Caitlyn September 4, 2012 at 7:24 pm - Reply

        Hi Jane

        Yes, the system we have here (in the UK) of vigilance does not work, I’m afraid.


  2. Amy August 31, 2012 at 12:11 pm - Reply

    Great overview , hopefully other journalists will bring this injustice into the publics view.

    • Caitlyn August 31, 2012 at 8:32 pm - Reply

      I agree, it’s a very good overview of the whole issue, thanks Jane.


  3. Liz Reece September 1, 2012 at 7:32 am - Reply


    If only this was covered in such a way in the UK then things might start to improve and more questions would be asked of the consultants who use mesh without informing of the risks or offering alternatives before using it.

    Caitlyn is right about the lack of a registry or even a device regulator that does what it says on the tin- ours is not interested in the problems with mesh and has not done anything as constructive as sending out a warning such as the FDA’s last year.

    Your site continues to educate and inform – thank you for all your hard work,


    • Jane Akre September 10, 2012 at 7:46 pm - Reply

      Thanks Liz- if you know some journos send it along, it’s really not that complicated once you get a handle on the situation and it’s all here, at least the basics. Hope you are doing well!

  4. EH September 1, 2012 at 2:11 pm - Reply

    Hi Jane, I too appreciate your hard work. Please add granulomas to your list of complications. I now have them also. It never seems to end – on to surgery #8. It is listed in the report that stopped mesh implants after 3 months, from 2010. Thank you for informing women, journalists and trying to get things moving to help us. Also, I’d like to add that the current lawsuits are not enough. This will be an ongoing problem for years. I know several women who did not erode until 10 years later. The statute of limitations shouldn’t apply – for some reason the asbestos suit for mesothelioma has an account set up for future problems – this should be so in this case also. It is just so unbelievable that a “minor problem” outpatient procedure that is minimally invasive causes life changing results. I know my life as I knew it is gone. How could they??? Life is not looked at as valuable anymore.

  5. jade October 18, 2013 at 2:10 pm - Reply

    Just to further address the “Editors Note*…” stated above – Back in 2009, Miklos and Moore claimed on their website (and I paraphrase) – “only doctors with good skills resort to robotic surgery…” and, my implanting surgeon pushed BOTH mesh and being a “premier” DaVinci surgeon”! He claimed he used the robotic surgery because he was getting “back problems”! NOT because it was better for the patient! WHY did I not register that? I know now that ANY doctor who downplays any surgery as quick and easy, minimally invasive is doing an injustice to his patient. These implanting surgeons prostitute themselves to the manufacturers and their GREED is well recognized by the manufacturers’ Marketing Teams. They will all eventually pay the price here and after”here” for their GREED –

    “In Dante’s Purgatory, the penitents were bound and laid face down on the ground for having concentrated too much on earthly thoughts.”

  6. jade October 18, 2013 at 7:42 pm - Reply

    CORRECTION: I mean to write “only doctors withOUT good skills resort to robotic surgery.” Sorry for typo.

  7. danyelle October 19, 2013 at 10:01 pm - Reply

    Thanks Jane

  8. Terri December 19, 2013 at 9:53 am - Reply

    Jane, Thank you for re-posting this and all your hard work.. I had searched for it before looking for the Editors note regarding surgeons cutting their own mesh instead of kits claiming it’s’s good to see the truth.

    Also, I agree with EH – I have also been diagnosed with Granulomas !

    • Jane Akre December 19, 2013 at 12:14 pm - Reply

      You can find it in Reporters Resource in the search bar… also in Reading Room. The search bar is underutilized I believe… there is lots of stuff there…. thank you!!!

    • amanda g June 23, 2016 at 1:04 pm - Reply

      How did you find out that you had granulomas

  9. Kim February 12, 2014 at 10:05 am - Reply

    Jane, I learned a lot from this post. This will be the post I refer people to that I tell about the dangers of mesh. Thank you for your hard work. When I return back to work I will make a donation. Everyone should give. Even if it’s a small amount.

  10. Sandy June 21, 2016 at 1:40 pm - Reply

    And the problem is if we don’t take their ridiculously low offers we still sit in pain and suffer and wait and wait we take out all of our 401 K’s our husbands had and we wait and wait because judge Goodwin won’t release the cases so they can go to trial and don’t tell me it’s not his decision because it is we’ve asked him to send this back he’s not ready to do that yet he thinks AMS will come through with a good offer I doubt it so slowly I sit here and I die everyday I deal with all the other symptoms that I’m having from the pelvic mesh surgery I’m almost sure that I’m going to die before I ever see a penny from AMS but I refuse to let them get away with taking my life and offering me Pennys for it everyday that goes by is another lost day everyday that goes by I lose more and more hope everyday that goes by I wonder how I can keep up the charade of not complaining about the pain everyday that goes by I pray to God please just take me home and let me be out of pain and agony let there be an end to this nightmare but everyday I wake up and the first thing I feel is pain and the last thing I feel at night is pain how this could ever happen in the United States of America is beyond me but it has sad thing is not that many people that can make a difference really give a damn

  11. Brenda June 21, 2016 at 8:11 pm - Reply

    Sandy…Please don’t give up…please don’t give in. There is hope, there truly is…He could be sitting next to you right now…He knows, we all know and feel it too…just don’t give in! I’m going thru so much too, just keep fighting! In sure there’s a special place in Hell for the people who contributed to our pain, not that that should make you feel better because it won’t…just keep going, you and I won’t be held down forever!

    • Sandy June 22, 2016 at 4:57 am - Reply

      Thank you Brenda so much for those kind words it really means a lot I try not to give up I try to stay strong and I know God is with me it’s just seems so hopeless some days but I trust my attorney he has not left me yet he’s a good man I think and if it takes me till the day I die I will not give in to these people who took my life from me many days I feel like I will fight them to the doors of Hell myself and then there’s those days when I just wanted to go to sleep and feel no more pain and hold my savior in my arms and just cry and know that I don’t have to feel pain anymore I don’t have to feel defeated anymore but for now my faith and my hope will keep me going one more day I guess that’s all any of us can do is just take one day at a time my sisters I feel for all of you and my heart breaks for each and everyone of you there are days I’m so mad that I just want to rip everybody’s face off and there’s other days I’m so sad I just want to cry until I can’t cry no more I guess what’s so hard as it seems that nobody understands what we’ve gone through too many think that we’re just women emotional drama queens that want to get money for nothing right hahaha I just want you to know that AMS is not better than any other company out there the only reason they decided to settle so soon is so they could give their little tiny settlements and not have to face 4, 5 or even 11 million-dollar settlements perhaps they are the sneakiest of all of these companies because they’re trying to get under the radar of juries and unless they come up with a really good settlement for me someday I pray to God that I can face these people in the jury and tell the world what they did to me and to the rest of you until then all we can do is take one day at a time and thank God everyday for Jane

      • Jane Akre June 22, 2016 at 9:39 am - Reply

        Sandy- I am so sorry… You did not deserve this. You had the same doc as Linda Gross so shame on him…. How does he live with himself!!?? knowing he has wounded so many women, husbands and families. I hope he knows. I pray for some peace and healing in your life.

  12. Louise June 22, 2016 at 6:46 am - Reply

    So tired and stressed out, about this horrible mesh…The pain, the agony, that we suffer everyday, is making me anxious, mentally,physically, emotionally and my Life doesn’t mean anything, anymore…So I know what Sandy is going through and many more Women, do feel the same way…When will they pay and go to Jail…In a way, for me they are terrorists…they are killing us…

    • Kitty June 22, 2016 at 6:48 pm - Reply

      Sandy. …you have been with us for a long time and continue to suffer. There really is no help for nerve pain.
      We have to do the best we can with our faith and therapy and a stiff drink now and then.

  13. Lordhelpus June 23, 2016 at 7:34 am - Reply

    All it takes is for one of them to be criminally charged and put in jail, to light a match on their furnace, and watch how fast they’ll all move. People need to stop rolling out the red carpet every time these guys stop in anywhere. It’s time to roll it back up and treat them as the criminals that they are, and show them that a criminal by any other name is just as evil, no difference…

    • amanda g June 23, 2016 at 1:05 pm - Reply

      I agree

  14. charrie e July 4, 2016 at 8:22 pm - Reply

    Hi Jane… I have had my case out since 2013 with Boston Scientific I have had two bladder slings and I am always in pain no quality of life Boston Scientific destroyed me. I have no money to get another operation. I’ve sold everything I had to pay the hospital bills. Now I live in a camper. What was Boston Scientific thinking. Shame on you for ruining Our Lives

    • Jane Akre July 4, 2016 at 9:58 pm - Reply

      Yours is a great example of why we need to abolish medicine for money in these instances and do the right thing- help women get the defective product removed from their bodies. That fund could come from manufacturers. To continue to allow women to be tortured because they cannot fund a surgery is beyond my understanding.

  15. Fran November 9, 2016 at 2:25 pm - Reply

    I have my mesh case in litigation for over 2 yrs. Nothing, no feedback from attorneys. Meanwhile I sit/walk/ sleep in pain. Drs don’t seem to understand, well they don’t have the ongoing pain and daily stress. Where to go from here??

Leave A Comment