Surgeons Challenge FDA Warnings On Vaginal Mesh

The debate over a controversial medical device used for women is heating up.

A nationwide coalition of pelvic surgeons is challenging a recent U.S. Food and Drug Administration safety advisory that warns of serious risks, complications and questionable benefits of surgical mesh implanted vaginally to treat women for a condition known as prolapse. The procedure is used to strengthen vaginal tissue that has grown weak or stretched, often after childbirth.

In advance of an FDA advisory panel meeting Sept 8-9 to discuss the safety and effectiveness of the mesh — and as attorneys across the country intensify their efforts targeting the device through litigation — pelvic surgeons say they e-mailed a response letter to the FDA outlining their concerns. A copy of the letter was obtained by CommonHealth.

“We have some significant disagreement with the conclusions reached [by The FDA] and concerns regarding the message that it is sending to our patients, the healthcare community, and unfortunately to the legal community as well,” says the Aug. 25 letter, which is signed by more than 600 pelvic surgeons, according to one of the organizers, Dr. Miles Murphy, associate medical director at the Institute for Female Pelvic Medicine & Reconstructive Surgery and Director of the Division of urogynecology at Abington Memorial Hospital in Pennsylvania.

Dr. Murphy, also an assistant clinical professor at Temple University School of Medicine, says he hopes the letter will “offer balance” to the FDA panel discussions next week. “It seems like the information that the FDA is working with now is very skewed,” Murphy said in an interview. “I’m hoping that the information [in our letter] will allow us to continue doing a procedure that in the right hands can be very beneficial.”

While acknowledging the risks involved in this and, indeed, all types of operations, the surgeons write that portions of the FDA’s analysis are flawed and the agency is unfairly portraying this particular type of mesh surgery as uniquely hazardous, when, in fact, for certain patients, it is an effective tool and “may be the best option,” the letter says.

Karen Riley, a spokesperson for the FDA, said she hadn’t yet seen the letter. But, in preparation for the meeting next week, she said the agency will post an “executive summary” of the issues related to vaginal mesh on its website tomorrow, which will include more details about safety findings, and other new information.

Here’s a little history:

In July, the FDA updated a 2008 safety alert after a rise in reported complications from vaginally implanted surgical mesh to treat pelvic organ prolapse, which occurs when the tissues that hold the pelvic organs in place become weakened or stretched out.  In prolapse, internal organs such as the uterus, bladder or rectum can slip out of place and bulge into the vagina, sometimes past its opening. It’s bad news, but it can be treated in many ways, depending on the patient, using both surgical and non-surgical methods.

(For context: Prolapse can also be treated using surgical mesh through the abdomen, which the FDA says appears to have fewer complications. Additionally, the procedure can be done without mesh, either abdominally or vaginally, and is known as native tissue repair. Both FDA safety advisories — the July update and the initial 2008 alert — focused on vaginally implanted mesh for prolapse, but the 2008 alert also included mesh for stress urinary incontinence. That’s another story.)

The FDA said the most frequent complications reported for surgical mesh devices used in prolapse repair include “mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.” The agency said that many of the complications required additional medical or surgical treatment and hospitalization.

In their letter, which Dr. Murphy says has also been submitted in a shortened manuscript version to the International Urogynecology Journal, the surgeons disagree with several of the FDA’s conclusions. Here are some of the major issues:

1. The Complication Rate

The FDA’s July update says that: “Serious complications associated with surgical mesh for transvaginal repair of POP [prolapse] are not rare.” It says in 2010 at least “100,000 POP repairs that used surgical mesh were performed” and “75,000 of these were transvaginal procedures.” The FDA cites 1503 reports of complications associated with the transvaginal procedure from 2008-2010.

The surgeons write that they believe this number “doesn’t represent an increase in the rate of complications; rather it is a reflection of the wide acceptance [of the procedure] by many specialists in POP surgery and an increase in the overall rate of how often these procedures are being performed.” In other words, more widespread surgery equals more reports of complications.

2. Greater Risk

The FDA says transvaginal mesh surgery “may expose patients to greater risk” than traditional non-mesh repairs. The surgeons say this assertion is “unproven by the existing literature,” and note that complications associated with medical devices (like mesh) are reported to the FDA –while complications from surgery not involving devices are not — so the agency is simply unable to compare apples to apples here.

The surgeons say they don’t want to minimize the risk of surgical complications, but:

“We…wish to highlight a fundamental reality within our daily surgical practices that we believe is not reflected or acknowledged in the current FDA verbiage; that is, in the surgical management of advanced prolapse, all treatment options involve significant risks. We are deeply concerned that the UPDATE portrays transvaginal mesh repairs as uniquely hazardous, providing no broader perspective (quantitatively or qualitatively) regarding the significant risks and/or higher recurrence rates associated with its alternatives. This introduces a huge clinical dilemma, and unjustified medical-legal exposure, for well-trained surgeons serving the vast ‘denominator’ of women undergoing mesh procedures.”

3. Erosion and Contraction

The FDA says that “both mesh erosion and mesh contraction [a previously unidentified risk where the mesh shrinks in the body] may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.”

In response, the surgeons say while erosion is a potential complication, it can almost always be resolved. “We are unaware of any published case reports in which mesh erosion from TVM does not resolve after more than two returns to the operating room,” the letter says.

Dr. Peter Rosenblatt, Director of Urogynecology and Reconstructive Pelvic Surgery at Mt. Auburn Hospital, a teaching hospital of Harvard Medical School in Cambridge, Mass., and one of the letter’s co-signers, told me in an interview that he doesn’t consider erosion a serious complication and feels it’s wrong that the FDA lumps it into that category. “It’s more of a nuisance than anything else,” he says.

4. A Flawed View

The surgeons write that “a fundamental flaw in the FDA’s analysis is that it is based on the question of proof of superiority of mesh in all patients.” But, they write: “No one is suggesting that mesh is recommended in all patients.”

Samantha Pulliam, M.D. associate director of the Division of Urogynecology at Massachusetts General Hospital in Boston told me she uses transvaginal mesh for prolapse in very few patients. “I think it’s a very rare circumstance where it’s truly indicated,” she said. “I like to choose the thing that will last the longest, work the best and be safest, that’s my feeling.”

“From our vantage point,” the surgeons’ letter continues, “it appears the FDA has presented a biased view of [trans-vaginal mesh] among all [prolapse] repair procedures because of the current reporting mechanisms in place…in our opinion, some of the statements made in the UPDATE would also contribute to further suffering by depriving our patients of surgical options that may be in their best interest.”

The FDA makes clear that the complications associated with mesh, which is produced by a number of different manufacturers, have not been linked to any single brand.

Still, the mesh manufacturers are centrally involved here. (Dr. Murphy told me no mesh makers had any part in the letter-writing process.)

I called Boston Scientific, of Natick, Mass., one of the mesh makers, and they referred me to the trade group for medical devices, the Advanced Medical Technology Association, AdvaMed. Here’s their statement:

“For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option. The use of surgical mesh has an established track record… Collaboration among medical device companies, physicians and regulatory bodies over the years has supported and sustained patient safety and innovation. We look forward to continuing to discuss this matter with FDA and other stakeholders at the upcoming advisory panel.”

Clearly, this is not the end of the mesh story.

Personal injury lawyer Mark Mueller, of Austin, Texas says he’s got about 1,000 mesh cases moving along at various stages in the legal process. He says he believes women are not fully aware of the risks of surgical mesh. “This, he says, “is just the tip of the iceberg.”

Readers, do you have mesh stories to report? I know this post includes no patient voices, and I know we need them. So please contact me, or post your thoughts, as we will be covering this issue as it unfolds.

Please follow our community rules when engaging in comment discussion on this site.
  • valencyspeaks

    Dear Dr. Rosenblatt:

    Obviously, you are male and therefore, seeing as you don’t have the anatomy to
    HAVE erosion caused by vaginal mesh, I doubt your ability to accurately assess whether erosion and exposure of transvaginal mesh is a serious complication or not. Seeing as how you don’t have a vagina and all that. However, I do. Consequently, I am *much* more qualified to
    decide if erosion is mere “nuisance” or a serious complication in my
    life.

    Therefore, as an expert in my vagina (or should that be an expert *of* my vagina?), I would like to
    tell you that erosion of vaginal tissue by vaginal mesh IS a serious
    complication for those who have to live with it. Erosion kind of feels like
    having a cheese grater shoved up our lady parts, other times it feels like a hot knife cutting into our most intimate parts.

    For me, the only time I don’t feel it
    sawing against surrounding tissue is when I am in bed, laying completely
    still, with four or five pain medications coursing through my veins. As long as I lay perfectly still, kind of like a cadaver, I don’t hurt. Hmmm…funny that cadaver analogy, especially considering this product was ONLY tested on cadavers prior
    to putting into living, breathing, WALKING, sex-having women. Now many
    of us who trusted doctors like you are still living and breathing, some
    of us are still walking with assistance, but many of us aren’t having sex anymore.

    Erosion might only be a “nuisance” to a cadaver, but then again, how would you know? Cadavers can’t complain, can they? They also aren’t subject to gravitational forces and, oddly enough, they don’t generally get up an walk around, either, seeing as how they are DEAD. The mesh works GREAT for cadavers! But for the rest of us? Internal Ethicon research reveals this mesh fails 33% of the time for us non-cadavers. That means there are 450,000 living, breathing women at this point who have been catastrophically harmed by a product you say causes a mere “nuisance.”

    Oh, Dr. Peter “Nuisance” Rosenblatt did I mention I have almost ZERO native vaginal tissue left
    over the apex of my vajayjay because of erosion and exposure? Essentially, I have a
    large, open ulcerated wound in my vagina. Isn’t that awesome, Dr.
    “Nuisance”? Did I mention I get to have a brand-new shiny one built for
    me, too? I am probably going to need a skin graft from my inner thigh to
    do it, too! That’s not that big of a deal right? I wonder if I get to
    pick my new vagina out of book like a girl does when she gets a boob
    job. “Ooo! I want that one!” Should I have my husband help me pick it out, since he’s an expert in my vajayjay, too? Or at least he used to be prior to this mesh being placed and us no longer being able to be intimate because of the excruciating pain the mesh causes. (And don’t **EVEN** go down the route of “you just had a crappy doctor put it in that’s why there is erosion.” The surgeon who place the mesh in me worked for Big Pharma as one of their trainers teach regular Joes like yourself how to put this stuff in. Dr. Urogyneoncologist has also been the president of the board certification group so let me tell you, there are few more qualified doctors out there to do this surgery. It wasn’t him, it really is the product. Pinky promise).

    Hey, I have a great idea Dr.
    Peter “Nuisance” Rosenblatt – why don’t we have this mesh put into YOUR
    wife’s lady parts, have some erosion happen, and then you can talk to me
    about how this isn’t a “serious” complication but more of a “nuisance.”

    Oh, wait. I have an even better idea. Why don’t we take this product, slice open your man-parts, jam it between your bladder & rectum, then use 8″ long crochet hooks to thread the arms through the tendons in your pelvis, making sure to hit the pudendal nerves on both sides while we are at it, then wait a few years as the mesh contracts – oops, the *mesh* itself doesn’t contract, but the cement-like scar tissue formed around the mesh causes the surface of the mesh to contract up to 50%. Once it has contracted nice and tight, especially around those pudendal nerves and you can no longer sit or stand for more than about 20 minutes and the mesh has become infected all the way back past the obturator fascia and you are having a foreign body reaction, then let some doctor go “digging” around for the mesh in YOUR pelvis in an effort to relieve the chronic, debilitating pain. (Oh, and be sure to take good notes on EVERYTHING you have done, because you are going to need them for all of your disability hearings after you get laid off from your job because you can’t work any more. After all, it is tough to do *any* kind of work when you are laying flat in bed, hopped up on 4-5 different pain medications, feeling like you have the cognitive capacity of a second grader, even though you have spent countless years preparing for an academic or professional career such as the one you have. Or I HAD.)
    After you have done that, THEN, and only then, can you proceed to lecture the rest of us about how this isn’t a “serious” complication but more of a “nuisance.”

    Nuisance my arse. Or would that be vajayjay?

    Sincerely,

    A Ticked of Consumer Who is ETERNALLY GRATEFUL You Are Not Her Doctor

  • Onlyhurtsothers

    Apparently the problems didn’t cause the surgeon any discomfort at all. In fact, they increased his income.

  • Had enough

    Does anyone happen to know of a Dr. that will remove mesh. Dr. must be between Portland Maine and Boston. I don’t believe Portland has any Dr.s that remove mesh. I have had enough of feeling like I have a meat grinder up inside of me, I’m in constant pain and sitting is a nightmare. It’s also effecting my legs. I don’t believe Dr. R. removed all my mesh and now he won’t return my calls. My symptoms are also falling on deaf ears. He also told me there is no reason for me to be in pain. I also believe this is way under reported. My reaction to the mesh in 2006 was immediately after waking up from surgery. Would never have mesh implanted again, ever

    • Revision Surgeries

      I would contact http://www.meshhelp.org for help with removal of mesh products. They are helping women without insurance obtain revision surgeries.

  • gopak

    I am doctor urologist from India.I happened to see some discussion by FDA,some doctors and some patients regarding vaginal mesh surgery.It was deeply saddening to know that the relation with doctors and patients are so bad in USA even when they preach about evidence based medicine.Is it the lack of trust and security in western world that separating the people ,the physician and the patient ,the teacher and student,the parents and children.I feel luck I was born in such place and I live in such a place where trust and relations are valued more than wealth.

  • Susie

    The God syndrome and arrogance of surgeons….Always CYA! That’s the real creed.

  • Rob Rowen

    Dr. Michael Margolis in Burlingame.CA. He is a well known uro/gyno that has never used mesh, and has testified before the FDA about the dangers in using this product. He has an excellent bedside manner, he takes the time to listen and explain, and from my research, he is one of the best in his field. I took my wife to him in April, 2012, and she is waiting for her surgery (Insurance approval) Give him a try, my wife thought he was wonderful

  • Rob Rowen

    The one glaring fact that the Doctors letter failed to address is that mesh treatment for prolapse treatment or other vaginal issues, generates a much larger fee for the surgeon versus native tissue repair. The doctor makes more money when he or she uses mesh versus older traditional repair modalities.
    For those who believe the doctors are not motivated by money, take a good look at the cars they drive, the homes they live in, and the lifestyle that many lead. While they may care about helping people with health issues, money is the reason they all chose to enter the medical profession. They do not preform these procedures for free, and you can bet that they do not return fees when a procedure has a less than expected outcome.
    When my wife had her mesh surgery the doctor simply told her that mesh was how they fixed these problems today, he never offered any alternative procedure, and she was never advised about any adverse complications reported with other mesh patients. After visiting a nationally respected specialist in the san Francisco Bay area, we were told about the bigger fees charged by doctors for mesh procedures. This particular doctor has never used mesh, and has warned others about the potential for serious problems regarding its use for over 15 years.
    This letter sounds like the doctors are circling the wagons, and protecting the hand that feeds them. The money involved in mesh surgery totals in the hundreds of millions of dollars every year, and that is a big revenue stream to lose. Medecine is big business people, like it or not, that is the simple truth.
    When you vote in November remember that there is one party in particular that seeks to protect the interests of big business, while limiting your ability to recover damages in law suits, and restricting the rights of women in general.
    This mesh issue is real, it has effected many women, and it has ruined not only their health, but their marriages and families as well. these companies should be required to pay dearly for the lives they have destroyed. Good luck to all those effected by this insidious problem.

  • Sales Rep

    Reading all of these is disheartening.  I feel for the women that have had complications from their mesh implants.

    Where the problem stems from is not your physician.  Where it stems from is the manufacturers of these implants.  This started as a specialty for Urologists, NOT Ob/Gyn physicians.  Why?  Simple……….. it is a urinary complication.  But, that was not enough for manufacturers like, Boston Sci, JnJ, Bard, etc.  They knew that majority of women who were seeking to resolve these problems would go to their OB/Gyn before they would go or be recommended to a Urologist.

    And they know that with the shrinking reimbursement the past few years, that it would be an easy sell to advise Ob/Gyn’s that they were fully capable of performing the procedure and why would you want to send your business to another physician?

    Here is their thought…………….the more physicians we get to do this, the benefit is huge profits for us (the manufacturers).  So we’ll put you through a 2 day course and give you a generic certificate that says “Your the best and you can do these all day long!”

    Don’t believe me?  Ask a urologist………..  ask if they have to fix any mistakes by Ob/Gyn’s.  The last thing an Ob/Gyn wants to do is call the local urologist and say, “Ah, I screwed up on this patient putting in mesh, please fix for me.”

    I am not stating that there are not well qualified and great surgical Ob/Gyn’s, but I am saying that there are more problems with unqualified surgeons with these specific procedures.

    The problem is that these companies put profits before patient care and that is a FACT!!!!!  I am a medical sales rep in this specialty, so I do believe this procedure does work when put into the hands of the qualified surgeon.

    I wish all of you the best.

    • Rob Rowen

      You state that the problem is not the manufacturer, then you state that they in fact push un-qualified doctors into preforming these procedures because they care more about profit than patient care. I believe that these companies do care more about profit than the quality of care that patients revieve. This makes these companies guility of the very charges that are being brought against them.
      When a business fails to properly research the safty of a product, when they offer bulshit classes to doctors in how to implant these products, and when they advertise these products as long term safe solutions to these problems, they are complicit in the commision of an offense against these women.
      I remind readers that when it comes time to vote, remember that there is one political party in particular that seeks to protect these huge corporation, while restricting your right and ability to sue them and recieve fair compensation for your misery. This party would like to do away with the FDA and the EPA and all other regulatory agencies, as they restrict (very little) the “big businesses” and their ability to make huge profits at the expense of those they trample or destroy along the way.
      I would hope that this sales rep will come forward and testify that these companies do in fact put profit over safety when it comes to this product. Doing the right thing is not always easy, but if you have a soul, you sleep better after having done the right thing.

  • Sherrig

    I was given mesh surgery wityhout being asket or informed about a foriegn object being put in my body. I have had nothing but trouble since it was put in. I was not informed about the mesh being used until after my surgery, then I was told that my insides were repaired with transvaginal mesh. I was still groggy from the surgery, and recall wondering why they would leave cloth(I was thinking mesh was cloth) in my stomac. I began getting infections immediately and have severe pain bleeding and all the other problems that comes with this surgery. No one should be given this surgery. I am on constant antabiuotics and pain meds that do not help. Hopefully women will see these coments and know not to have this surgery,it only causes pain,problems urinating,pain with intercourse and pain while your just sitting down. If I miss one of my antibiotics, I can’t urinate at all. With the antibiotics, only partial emptying. Please ladies, do not let them give you this surgery it’s not worth it. Your quality of life is no good after the surgery.

    • Bladder Mesh

      Hello Sherrig!!
      I was wondering where you were located at because I had the same thing happen to me ( I was not informed I was having this mesh placed in my body) , now the dr who performed this procedure is lying and saying that he told me!

  • Janice Stevens

    Janice Stevens
    Dear Doctor Rosenblatt,
    I think you need to take a long hard look at all of these comments again.  I had the Trans-vagnal mesh done March 30, 2010 and I have never recovered from this.  I lost my job and my insurance, and I am very angry that I was mislead about this improving my quality of life.  Each month that goes by a new symptom pops up, and I am in so much pain 24/7.  How dare you say this is a rare thing happening to women.  This has taken everything from me I cannot have sex with my Husband I have pelvic pain, vagnal pain, leg pain, and I cannot sit very long or stand long at all.  I cannot even take a long road trip, just trying to drive accross town I am in pain.  The surgen who did this won’t even see me unless I have $300 in my hand, and expect me to use Premerian at $160 a month for life. You and the other surgens are only doing this for profit, I know you get paid for using their products.  This is like the kid caught with his hand in the cookie jar!  I am on pain meds, and muscle relaxers 24/7 and they do not always work.  I will never trust Doctors ever again!  I want this mesh removed, and I want my life back. 

  • Doradw

    Hier in België word zelfs geen gehoor gegeven door de gezondheidsraad, het FAG.
    Slachtoffers moeten zich verenigen, maar hoe moeten we die vinden, hier is nog steeds een schaamte gevoel om met zulke onderwerpen naar buiten te komen. Het wordt hoog tijd dat er naar de slachtoffers geluisterd word, ze zijn al jaren het proefkonijn, van de op winst beluste farmaceutische bedrijven, en van de al te graag experimenterende artsen, die het dan in het bijzijn van een vertegenwoordiger nog aandurven om de ingreep uit te voeren. Weet je dat ze daarna de problemen niet kunnen oplossen! Hopelijk word er naar de juiste argumenten geluisterd, en weerom niet naar de grote bedrijven, en naar de gynaecologen, die misschien grote bedragen ontvangen, om net het produkt te promoten, ten kost van….. 

  • http://www.schmidtandclark.com/transvaginal-mesh trans vaginal mesh lawsuit

    This sounds like another case of “The Fox Guarding The Hen House” … seriously, the surgeons letter states “it appears the FDA has presented a biased view.”  This is ridiculous.  The FDA is charged with protecting the health and safety of American’s.  If anybody has a biased view, it would be the surgeons that make their money from putting this dangerous product in women.  I’d also be willing to bet that the vaginal mesh manufacturers supported this letter in one way or another.

  • Redheadclipper

    My Tears fill a river which now over flow to become a torrid ragging ocean this is how I feel daily. You have taken my life away and put me in complete utter termoil for the last 7 months. This is how long I have had my MESH in me and Two weeks after the Mesh was inserted I started to have problems not YEARS , WEEKS, Days to be exact… My surgery was Feb 3 2011 and on September 26, 2011 My new Doctor is going to try to remove the Mesh from my body… The constant pain is enough to make you question your life. You cant see past the pain it racks your body.  Sleeepless nights make it impossible to function in the day time, the excrutating pain from a bowel movement brings you to your knees on a daily basis. The mesh erosion has prevented my husband and I from having a normal relationship sexually . It has put a large strain on us not only due to the sexual part but the fact I have so much pain in a day it is hard to live with me. I ask all you Doctors who think a MESH is a good thing to take a moment and ask yourself would you like this in you… I invite all of you to come live in my shoes for one day just one day….. would you come ????? or is it better to sit from your Ivory tower and continue to do this kind of surgery on WOMEN!!!!! IS THE MONEY THAT GOOD YOU WOULD CONTINUE TO SUBJECT WOMEN TO THIS BARBARIC FORM OF PUNISHMENT…

  • Lawyerreferralservice

    I am a clinical Social Worker and have had the opportunity to take calls regarding the vaginal mesh on a helpline. The stories are horrendous. It is effecting the quality of life of women across the United States. These woman are suffering. Many cannot drive or sit and they are in constant pain. Others have severe urinary incontinence,bleeding, re prolapse and cannot drive. The pain is described  as constant with feelings like barbed wire. The line I answer is a lawyer helpline. i can understand physicians feeling defensive with the huge amount of litigation and FDA decisions but, the facts are out there. Women are suffering from these complications. To attempt to deny this  is insensitive at the very least and a blatant antithesis of the medical code and oath. I understand physicians were hoping to change the quality of life of their patients. But the truth is the truth. The stories are horrific. Physicians must see this with an open mind and heart.

  • Kcees13

     need help finding doctors lists for vaginal mesh removal in california my mom has it and is having major troubles with it and no one will help no doctors in this area

    • Jakre

      Kcees13-

      I just interviewed Dr. M. Tom Margolis who removes mesh frequently. He does not believe in transvaginal mesh placement. He is in San Mateo CA near San Francisco but there are not too many mesh removal people in the world. The other one is Dr. Shlomo Raz at UCLA Medical School Dept of Urology. People from all over the country, and the world, travel to have him remove mesh. See http://urology.ucla.edu/body.cfm?id=55.

      Just returned from FDA expert panel hearings and it is likely they will make mesh for pelvic repair a Class III and FINALLY require some science, but that will take years, and in the meantime at least 75,000 women will have this each year. They need to be informed!

      Jane Akre
      http:meshmedicaldevicenewsdesk.com

  • Jakre

    I just returned from the FDA hearing where they are considering a recall, or making mesh a device that must go through clinical trials for safety before it is sold. Presently there is no such requirement.  the stories from women were amazing, men too, and the expert panel was in awe. It is very likely they will not require pre-market approval AKA scientific scrutiny. Amazing that a permanently implanted device did not require that before. Really- no scientific trials, no assurances of safety. Just paperwork that claims the device is substantially similar to what’s on the market- and some of that has been withdrawn!! Mesh is very big business for the manufacturers and the doctors putting it in you.

    Please look at my stories, tell us your story and review the interview with Dr. Margolis about options. More on option in the next day or two- Stay well and Research!

    Jane Akre  http://meshmedicaldevicenewsdesk.com

  • Mbrrett89

    I had a trasvaginal mesh implant put in in October of 2009.  In November of 2009 I spent two weeks in the hospital with abdominal and back pain and no one could figure out why.  I continued to have paid, but in February of 2010 my health insurance was canceled (it was an individual policy) so I could not continue trying to find out why I was in so much pain.  In August of 2010 I was taken to the ER because of the pain and they told me they did not see anything in the CT scan but it was probably a stone so they gave me pain killers and sent me home.  I read about the mesh problems and started trying to to find out who I needed to see.  I contacted my gyno’s off and they told me I would have to pay for the full visit since I do not have insurance and I am a single parent and do not make enough money for that since I used all my savings account to pay my deductible for the surgery I had in 2009.  I am still suffering in great pain and I have been back to my gyno and was telling them all the problems I was having and he did a urine test, told me I have another bladder infection and gave me antibiotics even though there was no evidence of infection.  I am having to see a pain specialist now to try and block the pain so I can work at least a few days a week.

    I guarantee if Dr. Rosenblatt or any other surgeon who thinks this is not that big a deal has to live in any of our circumstances for one day, they would be fighting to get something done.

    I do not have the money to see another doctor to get the mesh removed so I am going to have to live with the pain and hope it does not cause such severe damage that I become unable to take care of my child.

  • High Anxiety

    I just had this procedure done a month ago and am still recuperating. The FDA report was brought to my attention only yesterday.  My surgeon did not mention it.  The jury is still out on how I will do. 

    I was sent home from the hospital with a foley catheter which was removed after four days.  Upon removeal I became incontinent which was NOT the problem prior to the surgery.  The intial problem was a severe rectocele.  I am presently on medication for the incontinence which is working but the side effects are terrible and I’m hoping that when I wean myself off of it the symptoms won’t return.I am curious.  How many of those experiencing problems had the surgery performed by an OB/GYN rather than a urogynecologist?

    • Ginger

      Hi Had the same surgery in EBof this year and obgyn did mine having urogyno remove mesh on the 26 of sept  good luck

  • Trina

    Well Doctor Rosenblatt,
    I am taking it that if your Penis had been wrapped in mesh and your scrotum had a mesh tape blindly fed through incisions and put arond your ureter, become infected then sliced up in a 4and half hour operation to partiallly remove the mesh and had left you with a distorted Penis and one that was now shorter and prohibited you from having sex followed by the fact that you wet yourself day and night and had bowel loss too,were constantly ill with low resistance to every illness going and spent everyday on painkillers. Whilst travelling far and wide to this surgeon and the next in the vain hope that you could have your health back as it used to be.

    I wonder do you counsel patients when it all goes wrong?
    You may have dedicated your professional career to urogynacoligic problems but these are not just problems they are life changing maimings by people who should know better.
    The span of time for complications to rear its ugly head is anything from immediately to years 7/8yrs later judging by some of the ladies I have spoken to and my own experience.
    So the next time you think about putting in writing such utter unfeeling rubbish just be grateful your Penis is intact!!!

  • Ginny robinson

    I had a hysterectomy/TOT Bard Vaginal Sling in Nov. 2008.  I returned to Dr. office soon after for what he called a “revision.”  I had exposed mesh.  I felt like I was sitting on a knife.  He cut the piece out and trimmed the edges and stitched to existing mesh.  I had have nothing but pain since I had this surgery done.  He continually treats me for yeast, pushes premarin, etc…When seeking second opinion, I was told I have no yeast; doc just trying to appease me.  I have had a huge dose of kenalog (a steroid) shot at the vaginal cuff when he inadvertantly sewed my stitches around a nerve.  I also had a steroid shot in the groin from the pain due to the sling.  I actually went to ER, thinking I was having appendicitis.  My urethra has a open tract (hole) beside it, which does not belong.  I am awaiting an appt at Johns Hopkins, however not until a couple months.  I suffer everyday, physically and emotionally.  I have not engaged in sexual intercourse for fear of pain.  I also have a friend who had the same surgery and has since had portions of her mesh removed at Pittsburg.  Please, FDA, listen to these complaints.  If I had it to do all other, I would just buy stock in Stayfree Mini Pads.

  • Lilithanne3

    I have had a abdoman reconstruction using mesh about 6yrs ago and I had surgery for a prolapsed bladder not to long ago, that surgeon said I have nothing holding me in just a piece of mesh laying over the top of my abdomon.  The reconstruction mesh eroded or something but now i have to try and find some one to fix it and no dr. seems to want to help now what do I do? my abdomon is in pain and I have hernias again.  I’m in big trouble with no help. Anysuggestions?

    • Jakre

      Lilithanne –

      You may try Truth in Medicine, a group formed by injured patients. They share ideas and suggestions for help … http://www.truthinmedicine.us.com  The group is led by Lana Keeton who has had 17 surgeries to remove mesh.

      I just interviewed Dr Tom Margolis who is seeing patients in an effort to remove the mesh.  See http://meshmedicaldevicenewsdesk.com

      Best-
      Jane Akre

  • Jane Akre

    As a journalist, I began covering this issue two years ago and have now created http://meshmedicaldevicenewsdesk.com to talk to injured women and men. Their stories are remarkably similar. We’re even talking to mesh injured women in Australia where there are few options for removing it once there are complications.
    Thank you for your reporting as well…

    Jane Akre

  • Meshy Business

    Of
    course, most people accept that when they go in for any operation there are
    general risks involved. My bladder was perforated during the TVT procedure and
    I accepted this as ‘one of those things’. However, before the operation, I was
    not fully advised of the long terms risks of voiding difficulties and erosion.
    Voiding issues were mentioned but it was implied that these would be temporary
    and would resolve within days/weeks.  I
    knew nothing about erosion.  My surgeon
    is a well respected authority on TVT and has produced studies describing
    complications and recommending that patients be fully informed of these risks.
    Unfortunately, for whatever reason (oversight, being too busy on that day – who
    knows) he did not follow his own recommendations.  Neither did he tell me about any alternatives
    to TVT.  I therefore assumed that it was
    safe and there were no other options.  Most
    patients go in to this operation trusting that their doctor would not perform a
    procedure on them that was not safe, nor implant material in their bodies that
    had potential for substantial harm.

    Clinicians
    like Dr Rosenblatt, who are motivated to help women, must feel it is a
    worthwhile procedure if they have many satisfied patients whose quality of life
    appears to have improved and I can see why they are reluctant to have these
    products restricted.  However, it seems
    that the unlucky women who have had complications, at the very least causing
    discomfort and a trip to the doctor’s office, and at the worst causing major
    pain/difficulties affecting their health, sex lives, relationships, day to day
    life and jobs, are being sacrificed for the others who are lucky enough not to experience
    problems.  I appreciate that there may be
    women who are desperate to have their incontinence problems resolved, but there
    should be stricter safeguards to protect women considering having these
    procedures.

    We may
    not hear from patients who do well with this operation but we are certainly
    bombarded with doctors’ websites, hospital information leaflets, manufacturers’
    brochures and magazine articles promoting this procedure as ‘minimally
    invasive’ and downplaying any risks. You only have to google “TVT operation” to
    find these. Googling “TVT mesh complications” tells a slightly different story,
    however.

    There
    must be more control over the approval of these implants otherwise they will
    carry on proliferating and being implanted in women willy-nilly without any
    regard to their safety. This operation is still relatively new and there is a
    lack of long term follow up data; it is now known that in some instances
    erosion can occur years after the original surgery. The numbers of
    complications are thought to be under-reported: in the UK there is no national
    register for these implants and so clinicians are relying on published studies
    which seem to give conflicting figures. 
    Many women who experience problems do not return to their original
    surgeon for obvious reasons so how can a surgeon be certain of his complication
    rates?

    Furthermore,
    there has been far too much emphasis on efficacy over safety in many of the
    published studies so far, and it is interesting that now the figures for the
    efficacy of these vaginal meshes have been challenged, the issue of safety is
    receiving more scrutiny.

    Thankfully,
    there have been some brave doctors out there who have been prepared to
    challenge “the Emperor’s New Clothes” from early on, and have exercised caution
    before using these synthetic meshes, despite no doubt enormous pressure to use
    them.

     

  • Rachel Zimmerman

    I asked Dr. Peter Rosenblatt to respond to Meshy Business. Here’s what he wrote:

    There will always be a small percentage of women who have complications from surgery, with or without mesh, and obviously complications can happen with ANY surgery, not just surgery for prolapse. While we rarely hear in the news from patients who do well with surgery, the unfortunate patients with complications tend to complain, and the worse the complication, the more they complain. Frankly, I don’t blame them, and I think I would behave the same if I developed a complication from surgery. But that does not change the fact that as a clinician who has dedicated my professional career to women with urogynecologic problems, I have seen that the overwhelming majority of patients who have these surgeries do very well, with long-lasting success. And I have also taken care of many women with mesh erosions / exposures, and again, the overwhelming majority of these are successfully treated with either a minor office procedure or a simple mesh excision and repair in day surgery under light sedation. In most cases, this is not a risky procedure and it is rare that these mesh erosions recur. I wish we did not have any complications from our surgery, but that is not possible, given the variables that we can not always control. But we do our best to reduce our complication rate, while trying to improve the success and durability of our repairs. And most importantly, we as clinicians must be able to diagnose and effectively manage complications when they do occur. Finally, it is incumbent upon all surgeons to properly counsel patients before surgery, so that they understand the proposed procedure and can make an informed decision about whether to proceed with the surgery.  
    Peter L. Rosenblatt, MD
    Director of Urogynecology
    Mount Auburn Hospital
    Cambridge, MA

    • jade

      Please keep me informed email on this story as it unfolds.  Thank you – a victim.

    • jade

      Can you publish the names of the 600 surgeons who have implanted these horrific kits in those of us without our knowledge/consent/disclosure?  And, the number of complaints against each one of them? 

    • Jane Akre

      Dr. Rosenblatt does not know the actual complication rate- no one does. The MAUDE database on the FDA’s website contains only a fraction of actual events as no one knows about it and it is almost impossible to use!    A minor office procedure involves stirrups and taking scissors to clip the mesh!   Yikes!  In the office it is not reportable.  The women I’ve talked to have had this and then they don’t return to the same doctor because, frankly, they don’t feel they’ve been listened to and there is a lack of trust.

      Then they are on the road to find someone new.  Often they are told the complications must be in their head. Often they are told they need antidepressants.   I believe that Dr. R may not actually understand the complications because these same injured patients may not be returning to him, or as happens in some cases, the doctor decides to discontinue with that patient for fear of being sued.

      At the very least a registry is needed to track post operative success, which the FDA panel decided now should include quality of life, not just a successful suture.

    • AGSLC

      An American Urological Association Foundation Health Policy Award funded study states ” most of the literature reporting results of slings does not meet specific scientific standards for outcomes analysis in that it lacks a comprehensive assessment of postoperative complications and focuses primarily on the degree of improvement of stress incontinence.” – women experiencing mesh complications certainly expected their surgeons to use an evidence based treatment, meeting scientific standards and not a device believed to be safe but never addressed for safety. As our problems have been marginalized systematically I am outraged by Dr. Rosenblatt’s comments. Not only is he sexist, he is either incredibly foolish or unscrupulous for endorsing a product that is used widespread by average gynecologists and urologists holding the subjective opinion that they are uniquely qualified pelvic floor specialists. As Dr. Rosenblatt is affiliated with Harvard, I suspect he is not stupid, leaving me to believe he is entirely unscrupulous and financially tied to industry. My vagina is talking to Dr. Rosenblatt….Harvard you have a problem, I am experiencing more than a nuisance.

  • donna_quilty

    I had a mesh operation for stress incontinence in June of this year. I have not had any problems, of course it’s still early days. This article was illuminating, as I hadn’t heard anything about problems with vaginal mesh. I do agree with the doctor’s letter in that the FDA data is skewed by what is and isn’t included and by how the data is collected. What was alarming to me is that my surgeon never advised me that there were concerns with specific complications of using the mesh and even worse he never advised me that there were other viable options available to correct my stress incontinence. Patients should be able to make an informed decision prior to surgery. I probably would have chosen the mesh because of its advantages; however, it is a good thing that the FDA’s warning and the ensuing debate with surgeons has finally resulted in bringing this valuable information to the public’s attention.

  • Meshy Business

    How dare Dr Rosenblatt refer to mesh erosion as not a serious complication and ‘more of a nuisance than anything else’!  I have read stories of women whose mesh complications are causing them daily problems and who have had to have multiple surgeries to remove it – mesh removal is another risky and difficult operation which many have to face and which doesn’t always solve the problem.  These women weren’t ill before the surgery and now have quality of life issues. I personally have had recurrent urinary tract infections, groin pain and have had to self catheterise 2-3 times daily since having TVT mesh surgery last November.  I’m now facing further surgery to have it divided.  I wish I could have the whole thing removed but apparently that is very difficult once the product has been inside your body for more than a few weeks – they didn’t tell me any of this before the surgery!

    • Jane Akre

      Yes meshy- I hear constantly from people who say their life is ruined. These are not complainers or malcontents. They are normal people who have suffered a horrific injury from someone they trusted. Unfortunately, what’s worse is the arrogance of doctors who turn their backs on injured patients as if to say “It’s not my doing” only adds insult to injury.
      Jane Akre
      http://meshmedicaldevicenewsdesk.com

    • suffering

      I am so moved by the empathy or lack there of by Dr. Rosenblatt.  I, like you, have suffered for 3 years.  I sometimes  take pain meds and 15 mg Valium just to go to sleep and forget the pain.  Wonder if the good doctor has ever had this surgery done.  Ask my husband how tired he gets of listening to me moan and groan.  Whenever I started with the groin pain, I had no idea it was sling related.  I went to ER on a Sunday, thinking I was going to need an appendectomy.  Thousands spent in tests.  Went back to OB/GYN who jumped down my throat for going somewhere else and informing me that  everything from my navel to my knees belonged to hiim.  He had told me numerous times that he did not like having too many cooks in the kitchen.  But on a visit after hysterectomy, I was having trouble with my breast retracting and his response was, “I am not a boob man.”  I had no idea what to expect from this procedure.  PLEASE. just wear a pad and forget it.  My life has changed drastically.

  • MichaelMacZesty

    My friends mom had a mesh operation and is now in litigation with the doctor who performed the surgery because of the nightmarish consequences of having it implanted incorrectly.

  • http://wbur.argosit.es/about/rachel-zimmerman/ Rachel Zimmerman

    Again, from Dr. Rosenblatt:

    “This person needs to see a general surgeon. Sounds like she had a mesh for a hernia and needs it evaluated. Any major hospital would have general surgeons familiar with this.”

    Lillithanne3: Are you in Massachusetts?