Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh

On a rainy night in early September, six women gathered for dinner at a Macaroni Grill restaurant in Gaithersburg, Maryland. They had come from around the country: Utah, Georgia, Florida, New York, Texas. But their mood wasn’t festive. All six were in town to speak publicly about their personal medical traumas in front of an advisory panel for the U.S. Food and Drug Administration.

Between them, the women figured they had undergone 45 surgical procedures to try to undo the damage resulting from vaginal surgery using synthetic mesh devices. The mesh implants were supposed to free them from the intimate discomforts that millions of women face after childbirth and as they age: pelvic organ prolapse, in which stretched, weakened tissues can allow the bladder or other organs to sag or bulge into the vagina, and stress urinary incontinence, which can lead to involuntary leakage with every laugh or cough. Once implanted, the hammock-like mesh was meant to shore up the supportive pelvic tissues and help keep sagging organs in place.

But rather than fix their problems, the mesh led to a range of far more awful complications. For some, the material eroded through the vaginal lining, causing infections and nerve damage, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and a halt to their sex lives.

“I was in the most horrendous pain I’ve ever experienced,” said Amy Gezon, a 43-year-old mother of three and one of the women who testified before the FDA advisory panel. “I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”

A Higher-Risk Device

The FDA, which has already detailed the serious complications linked to vaginal mesh surgery in a series of public health alerts – one in 2008 and an update this summer – is now considering reclassifying some of the devices into a higher-risk category that would require more evidence of safety and effectiveness, including clinical studies. A total recall of the products is unlikely — dozens of various mesh “kits” made by numerous manufacturers are on the market.

The FDA says it will make a final decision after analyzing the testimony and documentation from its advisory panel meetings in September.

Even the mesh manufacturers say they support some kind of regulatory action. Jeff Secunda, vice president for technology and regulatory affairs for medical device industry trade group AdvaMed (The Advanced Medical Technology Association), said in a statement:

“Industry remains committed to ensuring physicians and patients have appropriate information on transvaginal mesh products…In addition to the existing body of evidence supporting current products, industry supports the collection of additional clinical evidence for new transvaginal mesh devices (premarket review) and existing transvaginal mesh devices (postmarket surveillance), specifically transvaginal mesh used to treat pelvic organ prolapse. In follow-up to the FDA advisory panel hearings in September, representatives of surgical mesh manufacturers are working to arrange a meeting with FDA to further review the group’s recommendations for collecting this additional clinical evidence.”

But whatever the federal regulators decide, the proliferation of vaginal mesh has already created a major uproar in medical and legal circles and among women simply trying to cope with the tribulations of aging.

Some doctors are accusing the gynecological surgery industry of compromising patient safety for profits. Highly trained pelvic surgeons suggest that their less-specialized gynecologist colleagues are partly to blame. At the same time, hundreds of lawsuits have been filed against the makers of vaginal mesh products charging that the devices are faulty and the risks were buried under a frenzy of marketing. And consumer advocates are calling for an end to the regulatory process that allowed these devices on the market in the first place.

Clearance vs. Approval

First, some numbers: In 2010, there were at least 100,000 pelvic organ prolapse repairs using surgical mesh, and about 75,000 of those were transvaginal procedures, according to the FDA. Additionally, the agency estimates there were about 260,000 surgeries for female stress urinary incontinence, with an estimated 206,000 of those involving a surgical mesh “sling” placed under the urethra. Most of these mesh devices are composed of non-absorbable synthetic polypropylene.

Many medical devices, including the mesh products now under scrutiny, are not required to go through the rigorous approval process that drugs must face in order to win FDA approval. The language is even different: drugs are “approved,” devices are “cleared” through what’s called the 510(k) process, which simply requires that the new device is shown to be “substantially equivalent” to a comparable device already on the market.

Under this scenario, there are generally no gold-standard safety and efficacy trials; no tests in humans. “That means it’s possible to have generations of products cleared on the basis of one predicate device that was itself never studied adequately,” Dr. Anne Weber, urogynecologist and former administrator of the Female Pelvic Floor Disorders Program at the National Institute of Child Health and Human Development wrote in a 2009 article on treating prolapse.

In a report this summer, experts at the Institute of Medicine characterized the FDA’s medical device clearance process as “flawed.”

The group Public Citizen, which petitioned the FDA to ban vaginal mesh for prolapse, wrote that the experience with these devices “provides a ‘poster-child’ example of the fundamental failure” of the current process. “Despite a complete lack of clinical data demonstrating that invasive mesh devices were reasonably safe and effective for transvaginal repair of POP [pelvic organ prolapse], these devices have been heavily promoted by industry and their highly paid physician consultants. As a result, tens of thousands of women have been seriously harmed, many permanently.”

Despite the emergence of a strong anti-mesh movement, moneyed interests, such as venture capitalists, are lobbying Congress to try to ease restrictions on all types of medical devices, according to recent reports.

A Brief History

Surgical mesh has been used to repair abdominal hernias since the 1950s, the FDA notes. In the 1970s, gynecologists started using mesh products for hernia to do abdominal repair of prolapse. Twenty year later, that practice grew to include mesh for stress urinary incontinence and ultimately, prolapse repair with mesh implanted vaginally.

At first, “surgeons would cut the mesh to the desired shape…and then place the mesh through a corresponding incision. Over time, manufacturers responded to this clinical practice by developing mesh products specifically designed for SUI and POP repair,” the FDA wrote in a overview posted in September.

Transvaginal surgery with mesh was considered a more straightforward procedure for doctors not trained in abdominal surgery, says Dr. Samantha Pulliam, associate director of the Division of Urogynecology at Massachusetts General Hospital in Boston. Also, the mesh could be implanted in women whose tissue was simply too weak to use on its own for “native” prolapse repair.

In 2004, the FDA says the first manufacturers were “cleared” to sell ready-to-use mesh “kits” for prolapse repair, which contained specialized tools, surgical instruments and pre-shaped mesh.

These kits were quickly adopted not only by urogynecologists who specialized in pelvic surgery, but also by increasing numbers of general gynecologists.

Joanne, a 77-year-old widow who lives outside Boston (and didn’t want her last name used) had severe constipation and a dropped bladder and bowel due to prolapse. In 2009, after vaginal surgery in which her doctor used one of the mesh “kits,” she says she’s had no problems, and just spent a month touring Australia.

A Recalled Product

But new questions about the FDA’s “clearance” process are now being raised. A recent Bloomberg investigation reports on a vaginal mesh device made by Johnson & Johnson (as well as mesh from other companies) “cleared” by the FDA based on its equivalence to an older product that was recalled in 1999: Boston Scientific’s ProteGen Sling. (J&J, which is facing lawsuits over vaginal mesh, told Bloomberg its mesh products are safe.)

The ProteGen “had never been implanted in a human vagina prior to its clearance,” wrote urogynecologist L. Lewis Wall, a professor at Washington University School of Medicine in St. Louis in an article published in the American Journal of Obstetrics and Gynecology.” The ProteGen, for stress urinary incontinence, was recalled due to its high complication rate; the FDA called it a “misbranded” and “adulterated” product, according to a 2002 investigation published in the New Jersey Star-Ledger. (I contacted Boston Scientific with more questions about this but they did not provide answers.)

An Implant Problem

Synthetic surgical mesh is used in many thousands of surgeries each year for prolapse and urinary incontinence, and also for hernia repair. But when mesh is permanently implanted through the vagina, it turns out, things can get complicated.

The very concept of transvaginal surgery using synthetic mesh “defies core surgical doctrines…”

Bay Area pelvic surgeon, Michael Thomas Margolis told the FDA’s advisory panel in September that the very concept of transvaginal surgery using synthetic mesh “defies core surgical doctrines” because the vagina is defined as “clean-contaminated” due to its normal flora, including Staph and E.coli bacteria, which “can not be surgically cleansed from the operative field.” Dr. Margolis, who says he’s done scores of “salvage” operations on women with mesh complications, wrote:

“The implantation of contaminated synthetic mesh through the vagina defies basic surgical tenets because by definition it is not performed in a sterile manner. In fact so-called “mesh erosion,” the most common mesh complication, is in reality “mesh infection with chronic wound breakdown.”

And removing mesh once it’s been implanted is also problematic. Here’s how Dr. Margolis described it:

What it’s like to remove mesh from the surgeon’s perspective can perhaps be appreciated by this analogy. Extirpation of vaginal mesh is akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and power lines below. It is difficult if not impossible to remove all the mesh and do it safely.

In addition to erosion through the vagina, the most frequent mesh complications are “pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems, [as well as] reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems,” the FDA reports.

The agency also describes mesh contraction as “a previously unidentified risk where the mesh shrinks in the body” [it is after all, placed in a body part that is designed to expand when needed] that can 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.”

With all the complications, you might wonder why vaginal mesh surgery has become so popular. Some experts say that if you want to know why, you have to follow the money.

Deleting The Word ‘Experimental’ In A Bulletin

If not for a controversial shift in an influential professional group publication, vaginal mesh surgery might have had a harder time gaining popularity. And some physicians say the underlying force behind the procedure’s spread is money. Back in February 2007 — before FDA’s public health alert — the American College of Obstetricians and Gynecologists issued a clinical practice bulletin on pelvic organ prolapse.

The February bulletin warned doctors and patients to consider the vaginal mesh procedure to be “experimental.” It said: “Given the limited data and frequent changes in marketed products (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks, especially mesh erosion), the procedures should be considered experimental and patients should consent to surgery with that understanding.” (Bold is mine).

Seven months later, ACOG issued another bulletin on vaginal mesh surgery. This time, the word “experimental” was gone, in favor of what some might consider a softer warning: “Given the limited data and frequent changes in marketed products for vaginal surgery for prolapse repair (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks, especially mesh erosion), patients should consent to surgery with an understanding of the post-operative risks and lack of long-term outcomes data. 

Experimental procedures are often not covered by third-party insurance because evidence of their safety and efficacy is lacking. And two physicians, including one of the primary authors of the original February 2007 bulletin, have said that the threat of losing that insurance money was behind the change in wording.

“I think ACOG was choosing to protect its clinicians’ insurance incomes over patients’ well being,” said urogynecologist Dr. Anne Weber.

Dr. Anne Weber, the urogynecologist and former head of the NIH’s pelvic organ disorder program said that as the prolapse bulletin’s lead author, she vehemently opposed the change in wording. “I think ACOG was choosing to protect its clinicians’ insurance incomes over patients’ well being,” she said in an interview.

Dr. Wall, the St. Louis urogynecologist, warned in his January 2010 article that “powerful commercial interests are reshaping the field of pelvic surgery.” The ubiquity of the vaginal mesh “kits,” he wrote, “hold out the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeon and the device manufacturer.”

In a separate article on commercial pressures and ethics, Dr. Wall (a co-petitioner on Public Citizen’s call for a ban on vaginal mesh for prolapse) offers his analysis of ACOG’s revised practice bulletin:

“What is wrong with the new language? The experimental nature of these procedures has not changed; rather, in altering the text in this way, the ACOG Committee on Practice Bulletins shifts the responsibility for using these procedures from the surgeon (who should be acting as the patient’s fiduciary) to the patient herself, as if the signing of an “informed consent” document would be some kind of “universal disinfectant” that absolves the surgeon from any responsibility for what might happen afterwards.”

ACOG’s original response came in the form of a letter published after Wall’s article. Hal C. Lawrence III, then ACOG’s vice president of practice activities (now the group’s executive vice president) wrote, in part: “Shortly after Practice Bulletin 79 was published, the College received e-mails, letters, and phone calls from ACOG Fellows who objected to the use of the word ‘experimental’ to describe the anterior and posterior vaginal prolapse surgeries. Their concerns centered on the ambiguity of the word ‘experimental’ and their perception that ‘experimental’ did not accurately reflect the wide acceptance of these surgeries.” Lawrence rejected Wall’s argument that financial or insurance considerations were at the heart of the decision.

But Dr. Lawrence’s letter drew this published response from Dr. Weber: “In fact, the ACOG staff member at the meeting of the Committee on Practice Bulletins—Gynecology described the real reason for concern: ‘…recognition that the current wording would possibly deny payment for some physicians.’ Most of the clinicians who objected to the use of the word ‘experimental’ understood only too well exactly what meaning was intended — that the use of mesh kits as procedures for prolapse lacked sufficient evidence of risk versus benefit to adequately counsel patients as to expected outcomes. Such clinicians were concerned that insurance companies would not cover procedures labeled experimental, and they were concerned about their medicolegal risk should a complication arise in the course of procedures labeled experimental.”

I called ACOG for an updated response. A spokesperson sent me this email: “The word ‘experimental’ was interpreted differently among clinicians, and suggested to some that using surgical mesh was only permitted under the auspices of clinical trials, thus potentially affecting coding and reimbursement. Others interpreted ‘experimental’ to mean simply that its use was not standard of care. The Bulletin was revised to clarify that patients should be informed of the postoperative risks and lack of long-term outcome data.”

Weber, now a private consultant who lives in Pittsburgh, told me after ACOG published the revised bulletin, she tried to draw attention to the incident. She called a few reporters and spoke to a staffer with U.S. Sen. Herbert Kohl’s special committee on aging. The committee requested more information from ACOG, including details about financial support from the drug and medical device industry. But a spokesperson for the Senate committee said no further investigation followed.

Mesh Alerts

In 2008, a year after the revised ACOG practice bulletin was published, the FDA issued the first public health alert on the “Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.”

In July, the agency updated the 2008 alert, saying that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare…Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The agency cited 3,979 reports of serious complications associated with urogynecologic surgical mesh products. These adverse event reports spanned from January 1, 2005, through December 31, 2010, with 2,874 of them in the last three years. Outside experts have said the actual number of complications is likely far higher. A 2009 review in the International Urogynecology Journal cited synthetic vaginal mesh complication rates from 7% to 25% with cigarette smoking found to increase the risk of mesh erosion by up to threefold.

Complications Rising

Last year, a clinical trial comparing vaginal mesh for prolapse to traditional surgery using women’s own ligaments for repair was stopped early due to excessive complications, with more than 15 percent of patients experiencing mesh erosion. The New York Times quoted the lead author of the report, Dr. Cheryl B. Iglesia, director of female pelvic medicine and reconstructive surgery at Washington Hospital Center in the District of Columbia, saying: “The bottom line is not only there were more complications, but the mesh didn’t prove any better than traditional surgery.”

One of the key problems in the entire mesh controversy, says pelvic surgeon Samantha Pulliam, of MGH, is the criteria for selecting patients. She says in the rush to use what many thought would be a promising new device for prolapse repair, some doctors may have chosen inappropriate patients. For instance, she said, younger, fairly active women, who are still having sex and could have had alternative types of non-vaginal surgery or other treatments, were instead treated with vaginal mesh and experienced complications. “There are rare but acceptable times to use vaginal mesh,” Dr. Pulliam said. “Choosing the right patient is critical.” For instance, an older, less sexually active woman who can not have abdominal surgery or who has had recurrent prolapse after past surgeries might be a better candidate, she said.

Still, the American Urogynecologic Association put out a statement after its annual meeting Sept. 15 that the group “supports the judicious use of transvaginal mesh for [pelvic organ prolapse] repair performed only by surgeons with appropriate training on patients who have been fully informed of the risks and benefits of all available treatment options.” And a group of pelvic surgeons wrote a letter to the FDA this summer suggesting that the agency is overstating the problems with vaginal mesh. In the hands of adequately trained physicians, they wrote, and among carefully selected patients, vaginal mesh can be a useful tool.

Dr. Peter Rosenblatt, Director of Urogynecology and Reconstructive Pelvic Surgery at Mt. Auburn Hospital, a teaching hospital of Harvard Medical School in Cambridge, MA, was one of the surgeons who signed the letter. He says mesh erosion can be a “nuisance” but adds that for a minority of patients it is a serious complication. “The overwhelming majority of my patients are happy,” said Rosenblatt, who is also paid by Boston Scientific, one of the mesh manufacturers, to teach other doctors how to use the devices.

Not A Half-Court Shot, A Lay-Up

But some women with mesh complications say they simply weren’t clearly informed of the risks. Linda, a 44-year-old mother of three from South Hampton, PA is in the midst of litigation with one of the mesh makers and didn’t want her last name used. She said she went in for surgery after her bladder had dropped and was bulging into her vagina. The doctor made the procedure sound “uneventful,” she said. “He said, ‘It’s not a half-court shot, it’s a lay-up,’” she told me in an interview. Instead, Linda came out of surgery in excruciating pain, she says, with blood in her urine. She was rushed back into surgery to repair a punctured bladder. More problems followed, she said, among them: long-term self-catheterization, mesh contraction, hemorrhaging, blood clots, blood transfusions, more surgery to remove the mesh which had eroded to the point that her husband could feel it when they had sex.

Since her last surgery Linda says: “I’m leaking all the time, now I’m a pants-wetter. It’s been a nightmare.” She adds: “I’m not dying, I don’t have a terminal illness…but the last doctor I went to said ‘You’re going to be my patient for life… So, if I can get one person to not get this surgery it will be worth it.”

Kathleen, 52, of Collegeville, PA, also in the midst of litigation over mesh complications, told me she agreed to surgery on the cusp of a significant birthday. She didn’t have bladder problems, she said, but the bulge in her vagina made her feel particularly old. “I was turning 50,” she said. “I just wanted to be a better 50.”

If there’s one takeaway here, it’s this: patients must be their own most aggressive medical advocates. If you are considering this surgery, read the FDA’s suggested list of questions and take them with you to the doctor.

Amy Gezon, the Utah mom who spoke before the FDA panel, considers herself lucky. She spent about $50,000 in medical expenses and travel to get her mesh removed, and though she still has permanent scarring and recurrent pain, she says most of the mesh is now gone. She told the FDA that what has happened to aging women suffering from mesh complications is, in her opinion, “among the most egregious social injustices concerning women’s health.”

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  • Floridagirl

    The statement that the patient must be their own most aggressive medical advocate could not be any truer. I am 63, I had the TVS years ago, for the past 7 years I have had so many problems and my pain is getting worse as time goes on. Doctors want to be in denial. Although so many test show them 2+2 is = 4. I don’t know what their problem is , besides maybe trying to protect the insurance companies they now work for, or fear of doing the surgery to reverse the situation and therefore end up with legal complications because of the difficulty of the surgery. Meanwhile I am suffering.
    I have found a surgeon that is a urogynecologist in a nearby state that is where I well go for treatment if my attorney does not work with a funding company this physican office can refer me to a funding company. Ladies there is help. Doctors stop being scared to help us ladies, please ! We are not asking you to do anything outside your scope we wouldn’t want you to we have enough pain, just get our diagnoses right so we can get the proper doctor to treat us. Doctors you took an oath. Please. The patient is not your enemy we are suffering. Don’t let us go to the point that we end up with permanent nerve damage maybe the inability to walk, or whatever. We are being deprived even of our love life, if this was your wife or partner doctor wouldn’t you demand that she get proper treatment. Me I am a former nurse. I am a lady in pain.

    • gladia milles

      Miss i can understand that you are in severe pain why dont you complaint manufacture about this if u want help to get ur all expenses behind ur surgery then you can email on my email id tashu.jain1995@yahoo.com and its not any kind of scam but I am from medication compensation department we will help you out with our die heart

  • tj

    I had a rectocele repair in 1993. In 2006 I developed anal canal cancer. I have had extreme sensitivity with my pelvic bones, anal discharge similar to vaginal discharge where it is a clear mucus like, pain during sex and extreme bowl incontinence. I have always wondered if this surgery in some way connected to me developing cancer so I researched it and found they use mesh during this surgery. I have never seen a DR for these symptoms just chalking them up to after effects of radiation treatment and now I am wondering if the mesh could be a factor is this? Any ideas or thoughts or maybe there is no connection at all?

  • Kathleen

    I found an FAQ page that had many of the answers to legal questions surrounding mesh cases.. it can be found on this site http://www.vaginalmeshlawsuitscenter.com

  • MamaBear

    I had mesh placed in 2009 and was not made aware of the risks. My doctor led me to believe that it would be a simple solution to my problem with incontinence. I have had improvement since the mesh was place. However, I bled a lot during the surgery. When I woke up, they were checking my blood type in case I needed a transfusion. After being kept overnight, my hemoglobin was 5 (!) and I was transfused and sent home the following day. When I went to my primary physician, I was in bad shape and he sent me back to the hospital and I was admitted, tested for bleeding disorders, and the following day I received 2 more units of blood. When asked about this, the urologist who did the surgery said, “I was surprised that you bled so much. You’re very vascular down there. You’re younger than most women for whom I do this procedure.” (I was about 37.) I am about to have a hsyteroscopy for a uterine polyp and I am hoping I don’t bleed again…but after reading this, I again suspect (as I have before) that my blood loss was due to doctor error (perforating a blood vessel). Anyone else have a similar experience?

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  • Nita

    So I had surgery in 2007. The mesh can be felt vaginally and rectally! Who do I trust to remove it? I was told by my surgeon this was safe! Afraid now of bleeding rectally…… very painful

  • alyn918

    curious to know if you are still happy. I also was just fine after my repair, then about 4 yrs down the road I now have pain, chronic constipation, huge rectocele, to excruciatingly painful to have sex. I hope u stay happy, dont be surprised if not. Good luck. I now tell anyone who will listen to NOT have surgery unless absolutely necessary.

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  • Mleigh

    I am 24 And have been living with vaginal mesh since I was 21. I regret having the surgery. It has made everything worse

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  • chewey dog

    I have had leucocytosis since 1997, fibromyalgia 1995, & hypothyroidDIAGNOSED in 1993. I had transvaginal mesh implanted in DEC 2010. In the 2 years since, I (my body) has been EXTREMELY compromised, & I didn’t make the connection to a FORIEN object in my body until now. I did look into complcations of TRANSVAGINAL MESH but dissmissed it since my symptoms were atyipical. NOW however, I HAVE to take notice since I came to the point of COMPLETE MENTAL COLLAPSE & had to be HOSPITALIZED!I need direction on how to follow through with a lawyer. Problem is money. Any help would be appreciated. Thank you for your articule.

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  • Jodie

    I believe everyones body is different! What works for one, doesn’t work for ALL. I think there needs to be a certain criteria that they need to follow. For instance, the median age of this surgery is 68!! Huge difference in a person’s lifestyle when you are putting the device into a 40+ y/o woman. At 40+, you are still physically active, having (hopefully) sex, still dealing with children, etc. At 60+, you are slowing down a bit, not tending to the kid’s and their schedules, etc. Also, checking out the person’s immune system and tolerance for a implant that may wreck havoc on your system.

    That said, I had this device put in Apr 2010, the sutures eroded through with the mesh, requiring a second surgery. During the second surgery, they “tweeked” my bladded, informing me that I requested the procedure prior to surgery, which I did not. Since then, I have had difficulty urinating, suprapubic pain, overall pelvic, back pain, especially where my kidneys are, as well as difficulty with bowel movement. Initiailly, this procedure was sold to me as the gold standard and NOTHING else will work as well.

    I am now contemplating a 3rd surgery. They removed my cervix during the second surgery and now I have a fluid flilled cyst and require another surgery to remove the remainder of the cervix that they left in. At this time, I am contemplating removing the mesh, but the urogyn MD paints a bleak picture of the outcome. You could use your own fascia to suspend, but then it that doesn’t work, there isn’t too much of an alternative. You may need to sew your vagina closed and never have sex again…really!

    This is extremely frustrating and I have been in pain for way too long. Not sure who to turn to, but GOD! It is extremely frustrating to know what is the right answer to resolve this nightmare!!!

  • ValencySpeaks

    I was very happy with my repair until early 2012, six years after the mesh was placed. Then things went south very rapidly and I am now facing more surgery to repair the problems. I wrote this in a response earlier and I will add it as a comment here as well: IT ISN’T THE SKILL OF THE SURGEON. IT IS THE PRODUCT ITSELF THAT IS THE PROBLEM.

    The
    doctor who placed the mesh in me is a former president of AUGS
    (American Urogynecological Society). He has a reputation for being an
    incredibly skilled surgeon. However, 6.5 years later, I have massive
    erosion and extrusion, both into my vagina and rectum, leaving me with
    essentially no native tissue over the apex of my vagina. The mesh is
    infected back past the obturator fascia on the right side. I have
    permanent pudendal nerve damage from how he placed it.

    It isn’t the skill of the doctor. IT IS THE DEVICE AND THE DELIVERY SYSTEM.

    All three urogyns who have seen me in the past five months know the
    surgeon who placed the mesh. All three are **shocked** to see me in
    their office because most people believe just as you say, that the
    trouble is due to “non-expert” surgeons. According to the current
    president of AUGS, Dr. Peggy Norton, who examined me in September 2012, I
    represent the beginning of an onslaught of mesh complications because
    if *I* developed complications even though I had one of the most
    talented urogyns in the world place the mesh, then it means ANYONE can
    develop complications.

  • ValencySpeaks

    The doctor who placed the mesh in me is a former president of AUGS (American Urogynecological Society). He has a reputation for being an incredibly skilled surgeon. However, 6.5 years later, I have massive erosion and extrusion, both into my vagina and rectum, leaving me with essentially no native tissue over the apex of my vagina. The mesh is infected back past the obturator fascia on the right side. I have permanent pudendal nerve damage from how he placed it.

    It isn’t the skill of the doctor. IT IS THE DEVICE AND THE DELIVERY SYSTEM.

    All three urogyns who have seen me in the past five months know the surgeon who placed the mesh. All three are **shocked** to see me in their office because most people believe just as you say, that the trouble is due to “non-expert” surgeons. According to the current president of AUGS, Dr. Peggy Norton, who examined me in September 2012, I represent the beginning of an onslaught of mesh complications because if *I* developed complications even though I had one of the most talented urogyns in the world place the mesh, then it means ANYONE can develop complications.

    • Amyslc

      @valencyspeaks is your mesh for SUI (TVT or TOT) or pelvic prolapse.

    • James Falasco

      Your story is of course unfortunate . My question to all the women who have experienced this situation is why you aren’t addressing the point you make about the device more? It is indeed the quality of the device . Why do we extend bumper to bumper warranty and then place a mesh device that if it was inspected it was done so using 50 to 80 year old technology. See work at ww.automatedinspectiontech.com that addresses quality control issues.

    • Carlina

      Valency……………HELP!!!!! I also have pudendal nerve damage. My question is do you get disability? It has been almost 2 years and still pending. If anyone is reading this and can give me some input it would be so helpful. This is the worst pain in my life…thank god for pain meds. PLEASE SOMEONE RESPOND>

  • needing help

    Plzzz i need help,im a mother of 4,grandmother of 4,and in 2010 i had to hav a historectomey also mesh sling for urinary incontince. I was never ever told of any complications actualy wast told of it at all untill right before surgery. These 2 yrs hav been hell for me and my husband an my family. I use to work be out going active but that all changed in a heart beat. My ob/gyn never listen to me when i said something is wrong im i bad pain leaking urine again chronic discharge lower back pain pain in my legs bad constipation. My dr kept trating me for UTI after antibotics over an over still no change. I had been to er many times had hav my bladder drained,the outside of my vagina as well as inside was swollen but the outside was horrible one last timei went to my dr with swollen vagina and he gav me 4 meds treating me for yeast infection an some other infection. Told me no sex after i hav told him for a yeari havent had sex becuz the pain was terrible not only for me but my husband as well an i would bleed everutime.I found a uronilgist and he imedently said ur mesh has got to come out. I was sceduled for surgery day befor thanksgiving 2012 and im back to leaking i cant go a min without i feel like im wearing a diaper still chronic discharge groin pain up to almost my inner hip or thy bone idk what u call it,i feel pressure on vagina an my butt like im pregnant an need to push constantly and cramps with pain in lower pelvic. I called one of the attorneys on tv about year half ago they sent me a questionare to fill out sign an send back I DID that. Never hav i heard back from them. I have called told them i needed help and there words was right now were working on women /men that has had to hav mesh removed. I said i dont hav any money no insurance and nobody will help me. So i contacted another attorney told him everything and he said that if i signed a contract that meant i was retained by an attorney. But i was told by a women that if i wrote a letter in my handwriting telling them i no longer needed there sevices because i felt like they had done nothing to help me and wasnt going to. I signed it dated put my address for them to send my medical records to me. I made 3 copies an sent them one thats been almost 3months. I havent herd a word. My current insurance will not pay for anytbing cuz prexisting so plzzzzzzz i know this is very long and i pray someone reads it and can copy past send to someone who can help me. My cell # 205-495-7067 Thank u so so very much. I feel like im going crazy an at times dont want to live,and i hav a family. I dont want the rest my life to live this way.

    • gladia milles

      you can contact me on tashu.jain1995@yahoo.com if you are interested in compensation and its not any kind of scam ok

  • http://www.facebook.com/profile.php?id=678148252 Rebecca Mshar-Oprish

    I went to my doctor for a rectocele repair and ended up with a hysterectomy and a partial mesh sling. During insertion of the sling, my bladder was ripped so severly it took 8 1/2 hours to repair. I have since had 4 more surgeries to remove the eroding mesh and both ovaries because they were also stuck to this junk. PLEASE do NOT have mesh inserted into your pelvic area. It causes pain and death. It’s been three years and I’ve never felt the same. My poor husband has had to endure this with me and I’m really surprised our marriage has survived.

  • Joylene1919

    I am 54 and had the rectocele and cysotcele repair in 2008 just 3 months before the recall of the mesh.  Immediately after the surgery I was unable to urinate.  I had to self cath for five months before deciding to have the sling “released”.  After that second surgery a started leaking again. For the next two years I continued to leak and had an almost continous cramping/aching in the area where my bladder is…never really thought must about it.  The pain started getting sharper.  In January of this past year my husband had surgery for prostate CA.  He did extremely well and after almost 3 months of no sex,  when we had intercourse, the mesh cut him twice pretty bad and he told me “you have something going wrong down there.” Sure enough I had two large areas of erosion. Under went extensive “PAINFUL” surgery to remove as much of the mesh as possible that had already adhered to my bladder in April.  I am now scheduled for another surgery next week to remove even more that is eroding. I am fortunate that I have a wonderful caring doctor.  She has cried with me several times.

    • http://twitter.com/amygezon Amy Gezon

      It is nice to hear you found a physician with enough ego strength to express empathy. Most of us experiencing these complications have not. Sending thoughts of peace and hope for a meaningful recovery from your surgery next week.

  • Care Bear

    Dr.Rosenblatt  thinks it is a nuisance to feel like a curling iron has been inserted into the vagina and turned  ? My God does he ever need a lesson in empathy! and 2 more surgeries to adjust a torturous medical implant is OK!!!! Obviously  he makes a lot of money from doing this to women!!!! will he someday decide not to work for mesh pushers and then make lots of money removing mesh?

  • Sedina Gray

    My mother is 48 years old, and is now about to DIE due to complications of this mesh….we have no money or insurance to provide the surgery she needs in order to remove the mesh. So, I am helplessly watching her die a slow and painful death.

    • lisaMSW

      please see vaginalmeshhelpline.com or call 1 877 522-2123

    • Farid

      This is difficult to hear, why does she not contact an attorney?

      • Sal

        She should try contacting an attorney, we used a good one for my moms case call me if you need a number 310-980-9416 or email me salarh@gmail.com

  • love34

    These articles scare me sometimes and I try not to think about it I had a mesh net put in when I was 30 and have had no problems. But I wonder if I have slow symptoms Im not noticing like this is to good to be true. Either way I take my life one day at a time.

  • Angela Hughes Halliwell

    FIrst, I have to say that I really believe that the urogyn resources here in Boston like Peter Rosenblatt, May Wakamatsu, Iman Elkadry and others are stellar and the work they do is, in most cases, simply amazing.   When I saw this topic and these comments, I wanted to share that I, too, was told that TVM would solve postpartum urinary issues because I had done extensive pelvic floor PT with a wonderful women’s health practice in Newton but had lingering symptoms.  I decided, for a number of reasons (honestly mostly due to not wanting to “deal” with another recovery at the time) to put the procedure off for a while.  I’m now truly thankful I did because with time and a bit more PT I can happily report that my issues are TOTALLY RESOLVED!  I know that many physical complaints fall outside the realm of PT but I find myself often imploring women to exhaust non-surgical solutions, really spend the time on things like targeted PT with experts like those at Marathon PT’s women’s health center.  Surgery seems like a straightforward fix, I think, but it can also open the door to more complex complications.

  • Concerned Citizen

    Another egregious social injustice concerning women’s health is the drug Lupron. Doctors act like it is safe even as victims’ groups and petitions spring up all over the Internet. Since it cures no illness, one wonders why are gynecologusts and reproductive endocrinologists so eager to subject patients to its risks? I took Lupron only once and it damaged my connective tissue, so now guess what I need? Surgical mesh!

    • Care Bear

      exhaust all other alternatives first!!!! and then think twice, it is a big gamble not worth the cost to your health…..

  • Merisa

    I also have had TVM. My case is unique though. I am now 22 years old. At age 17 I was diagnosed with Mullerian Agenesis Syndrome. My uterus is severely underdeveloped, and I have no cervix. Because of this, I developed a vaginal vault prolapse. I had my first surgery April 2011. I believe Mpathy mesh was inserted. About 6 – 8 months later, my partner noticed he could feel the mesh inside. It basically felt like wire poking out. I recently had a revision in January. Beef skin was used as a patch. My recovery is going well so far aside from pain every now and then; however, I am scared of what the future may bring. This is just the beginning of living with TVM.

    • Lupita

      Merisa, I just read your article you are so young. I just posted my notes also today I had the mesh implant on August 2011. Thank God that he has guided me because I can’t even think straight. Joel Osteen Ministries keeps me going I don’t miss the days he preaches, pray to the Lord to guide you and help you with the cross you are carrying I’ll add you to my prayer list. May God Bless you and your husband.

    • gladia milles

      contact me on tashu.jain1995@yahoo.com if you are willing for your compensation contact me

  • TressaB

    this letter is to all women who are facing surgeries.  First off, let me state that I have nothing but the highest respect for members of the medical proffesion. However, like most professions I am afraid there are a few bad apples in the medical barrel. I know I have just encountered one.  I have been going to the same obgyn for about fourty years, never a problem. In May,2010 I went to this doctor thinking I had some kind of bladder infection. Before I knew it, surgery was scheduled for me in in June. Not one surgery but three :a hysterectomy, a bladder tuck, and a  colon tuck. My life has never been the same. The only surgery of the three that seemed to come out all right was the hysterectomy, and I am still holding my breath on that. After the surgery I had to wear a bag for two months while the doctor tried to figure out what happened. I was sent to a urologist by the obgyn. The urologist seemed to be exasperated because I had beenn wearing the bag for such a long time, and removed it. Next, the obgyn sent me to a neurologist? Haven’t figured that out yet, but then I’m not a doctor. I had a nother surgey in November by the same obgyn to correct the first surgery DID NOT WORK had third surgery in December to correct the first two surgeries, did not work either.  And yes i did sign papers autherizing the surgeries how ever  I was not told the downsides of and the forms were not explained to me, about the possible dangers of the surgeries. No information was given prior to the surgery about the  possible side affects or complications of mesh implants I ened up going to vanderbelt hospital were I was told by doctors there was permanent damage from the mesh surgeries that were irraversable. So I am ruined for life.   I have since then  been told by three attorneys that in the End the obgyn can not be held accountable for his mistakes. He goes his merry way and I am ruined for life! Why? Politics? Lobbyists?  I think that state legislature laws that protects the doctors needs to be changed to protect  the patients. I am stuck for the rest of my life having to cath and deal with other medical problems due to the mesh what does the doctor who did this have to deal with.  Sincerely unfair                        

    • Missydenny

      Hello,
      I am going through the same thing.,, the mesh has scarred to my bowels, cervix, bladder and abdominal wall.  No sex it it excruciating.  constant spasms.  Dr says maybe its chronic fatigue?   It is a shame.  I am a 42 year old women with 4 young children… And a fed up husband.  Dr gets paid and goes about his life while continuing the same surgery on hundreds of women…

  • Sherrig

    Transvaginal mesh should be banned by the FDA, these cause so much problems for women, as well as their husbands. I have severe pain, even during serx. My husband and I went from sexually active to not at all. Pain prevents sleep wakes you with pain, constant infections, problems urinating, adhessions high in the stomac and numerous other problems. Hopefully the FDA will demand a recall, and ban these devices. They create terrible lives for people.

  • Sherrig

    I was never told that this device was beeing put in my body. I don’t see how a doctor can put something like this in someone without asking them or telling them that they are putting a foreign object in their body. I was told when I was coming out of anistetic after the surgery that a transvaginal mesh was implanted in my body. I was never warned about any adverse affects it might have in the future which began immediately.This should not be done to people. We are human beings and should be treated that way.

  • Sherrig

    In my case, I was not told that a transvaginal mesh would be put in my body. I did not know what it was after the surgery when I was told it was put in me. I did not get a chance to say yes or no to this because I was under the impression that my insides would be sewn in place,not that a foreign object would be placed in my body. I was not told about it or any adverse effects before or after the surgery. Hard to make an informed decission when you have never been informed. Guess it beware of doctors.

  • Sherrig

    I’m glad your surgery was a success, but there are thousands of us that can’t say the same I have been in pain for several years now because of the mesh. You need to watch for blood in your urine and reaccurrent urinary tract infections with a lot of pain, bleeding and pain during intercourse as well as pain while sitting or trying to go to sleep. Hopefully you will never have to go through this, but a lot of us do and it isn’t right to do this to people. Gooed luck

    • Decomom

      I had the mesh surgery in 2003. I am looking for information regarding intermittent bleeding during urination. It doesn’t happen all the time, is quite uncomfortable, I pass small blood clots and the bleeding last 5-6 hrs. Have seen 3 surgeons and am told it’s a mystery, one even told me “so you have a little bleeding now and then, no big deal” well it is a big deal to me and wondering if anyone else has this same thing happening to them. I also have many of the same issues stated here. Wish I could find honest information regarding removal.

  • Sherrig

    I was not told anything either, I was told they would sew my insides in place. After I woke from surgery, I was told about a mesh being put inside of me. Have had so many problems since. Hopefully you will get yours out, and feel better. I am trying to figure out how to get this one out of me. Good L uck& keep us informed

  • Sherrig

    I totally agree, had I knownin 2004 what I know now, this thing would not be in my body. I saw an article that said this was experimental in 2008, I wonder what it was in 2003&2004 when I recieved one without my knowledge?

  • Sherrig

    I would have been more allert, had I been told about the mesh in 2004 when one was placed in my body. I was told after the surgery that a mesh had been implanted ,and never told about any adverse things about it. I have had a terrible quality of life since the surgery, and only heard about the adverse affects(of which I already had) several months ago. Hopefully doctors will inform their patience, that was not the case with me or I would not have had the surgery.

  • Rnklein

    i had urinary issues after my sling was put in.  I had pain.  I told my Dr. and he told me to give it time.  It never got better.  5 months later I was in emergency surgery because of excruciating pain in my pelvic area.  When the Dr. looked inside, I had puss in my entire pelvic area, and apparent tub ovarian abscess these are caused by urinary problems and I know that that was my issue, he said I was full of adhesion twisting my organs all up and adhering them to my pelvic walls and each other,  which I also know came from this infection living inside me for 5 months.  I believe this sling is the reason he had to do an emergency bilateral salpingo-oophorectomy and total hysterectomy as well as remove a perfectly good appendix.  he told my husband I was lucky to be alive.  I was 40 years old at the time and still had many active healthy years ahead of me.  That all ended because of this thing that is still inside me and as we speak causing havoc on my internal organs, that is, what is left of them.  I am feeling pelvic pain and cramping often. I can’t find any information on the infection or issues I experienced. all I keep hearing about is erosion,  this thing has destroyed my life and to top it all off I have to rush to the bathroom every 15 minutes or I will wet my pants. It clearly isn’t even helping with retention any longer. Someone please tell me about how this could have infected my whole pelvic area.  Please, I just want answers. Please….

    • Amygezon

      How awful, I am so sorry you have had to go through so much.  Dr. Margolis has posted his testimony-his theory, though some disagree with him may explain your infection. I had my mesh removed entirely by Dr. Miklos in Atlanta, others have gone to Dr. Raz at UCLA and Dr. Zimmern in Texas. Margolis also removes mesh. Just about anyone with a license can put the stuff in (and often very incorrectly) but few seem to know how to address complications even if they were to admit there was a mesh complication.  You may want to visit this site-http://meshmedicaldevicenewsdesk.com/?page_id=102. There are a lot of women on there with similar issues and links to chat rooms and websites that may be of some help to you. 

      • Motherpink5455

        To Amyslc
        you need to have that mesh removed,it is poisen!mine eroded and was stuck to different organs,3 surgeries later they say all was removed but i doubt it,I have  bladder spasms,pee 20 times a day,can not have sex which has about ruined my marriage and have frequent utis,my case is witha lawyer but who knows what will come of it,,,get the crap removed!!!!

        • Sherrig

          I am sure trying to find someone to remove mine, have been severely sick and in pain since it was put in without my knowledge or permission. Hope you will be ok in the future, those mesh slings should be banned. Good luck

          • Amyg

            I went to Miklos in Atlanta, most women who have had a good outcome with removal that I have encountered have gone to Dr. Raz at UCLA or Miklos and Moore in Atlanta.  Most who have had partial removals have had worse complications and required multiple surgeries to remove mesh.

    • Amyslc
      • Nadine16

        Hello, I am 31 years old and just had a pop and tvt sling inserted for incontinence and my obgyn also fiddled around inside my bladder to fix some kind of other issue. I was told about the mesh through a pamphlet and a few articles on the web that he suggested. I have no fault as of yet with my dr but I am already having some serious issues and it has only been 8 days since my surgery. Now first I was accepting some down time seeing my mom had the same surgery on April 16 but she only had slight issues with not healing very fast and raised the dr so I went to him also. He immediately said I needed surgery as well. So I did it cause I was tired of urinating on myself whenever I did anything. I have had problems down below before with 3 miscarriages and a bad cervix plus complications when having my only son who is now three. I want to keep my uterus and was told that would not be an issue only when I have more kids I may need this surgery again. But anyway the point is I am scared to death now from reading all of this stuff.I had an issue at the hospital and was kept an extra day because I could not go to the bathroom yet alone. The second day, they preformed the same bladder test as the day before but put so much fluid in me it had no choice but to come out. So of course I was sent home. That is where it began. I started to have excruciating pain when trying to sit on the potty. I could not release any urine but perhaps a drop or two in two days. That Monday I called my dr and they saw me that day. He claims they never should have let me go from the hospital and removed over 850 ml of fluid from my bladder! It was at the bursting point and would have ruptured if I had not come in that day which was scary to hear. I had also attracted a bladder infection supposedly from the cathitors at the hospital. I was sent home till that Friday with a catheter to supposedly give my bladder a rest along with three types of meds for the infection and the bladder. They did the test again on Friday and still tons and tons of pain and no urine being released. Once again I was sent home with another catheter and more medicine for my bladder along with a antibiotic for a vaginal infection I now have on top of the bladder infection. This is crazy because I was suppose to heal fast and be ok, instead I am stuck with a catheter and pain that is out of this world. Good thing I did receive pain meds but what happens when they don’t give me any ore? Also i am to get another test this Thursday to see if the bladder will work again. My question is why is this happening? Where are all these infections coming from and why was I told the TVT sling was the only mesh used and that it is not associated with these mesh warnings? And why does my bladder no longer work at all except to give me great pain. Can you have mesh problems and complications so early after surgery? I am still so young and am scared and depressed and just sick and in pain all day and night from this with infection after infection and leg and button and back pains and it is even hard for me to go poo now as well even with all the medicines I am on. Please someone answer my questions because I get none from my dr but the assurance it will go away and my bladder will work again. Also that the pain was from by dyes of sutures he removed Friday because the knots where showing but really it’s my body pushing them out and the sutures now being infected and coming open as well.

        • http://twitter.com/amygezon Amy Gezon

          I wish there was a simple answer. Sadly what you are describing is increasingly common. Find another doctor preferrably a pelvic floor specialist-urogynecologist. These are complications your surgeon should have told you to anticipate. What we know now is to safely remove the TVT mesh you have approximately 4 weeks before it permanently adheres to tissues making it extremely difficult if not impossible to correct.

      • Lupit

        G. Tagle On August 2011 I had the mesh implanted by GYN Dr. Gabriel Medrano and three other doctors and 2 (two) students. I don’t know where their brains were because to begin with I didn’t need 4 doctors. I guess the two students did the surgery with no supervision from this four doctors, can’t make heads or tail from the mesh they left in. I am having a lot of complications and infections. I wrote a certified letter to the UNIVERSITY HOSPITAL IN SAN ANTONIO over a month ago and also a certified letter to Dr. Medrano and have not received a response. They don’t care how I am feeling they’ll just keep doing again. I KNOW THAT THE PETS ARE TREATED A LOT BETTER THEN US HUMANS BLESS THE VETERINARIANS ! I am going to need several surgeries to repair the damage this doctors did. I will write their names later. I am from San Antonio, Texas, I had told the GYN Dr. that I didn’t want the mesh implant because on July 14, 2011 the same day I had the appointment there was a report from the FDA about half a page came out on the newspaper and the doctor read the article where it advise the public and the doctors to be careful about the vaginal mesh and all the problems it caused. It went in through ONE EAR AND OUT THE OTHER. Ladies stay strong and pray and let’s keep on fighting and wake up other ladies to think twice about what doctors we choose. God Bless everyone of you.

    • Sherrig

      I have had constant infections since 2004 when I recieved the mesh without my knowledge. I had to have a hysterectomy also and had massive adhessions in my upper stomac from this sling. I still have severe pain and a lot of other problems. I have to stay on constant antibiotics due to infection and urine retention. Even on antibiotics I don’t empty all the way . Problems with bleeding and severe pain during sex. Also pain while sitting. Pain at night, and I can’t sleep. When I do fall asleep, I wake in pain. Medication does not help the pain. The infections are from the mesh, and hopefully I can get this removed in the near future. Hope things get better for you, and hope this info helps you to understand the infection is from the mesh.

    • Care Bear

      some of the meshes will not allow our bacteria, infection fighting cells into the mesh that harbors the bad bacteria…so we end up with chronic infection, chronic Foreign Body Response,chronic pain and exhausted immune systems, which leads to auto-immune diseases……the foreign Body Respose that causes the scar tissue to form and integrate with the mesh does not turn off in many women’s bodies, and therefore we end up with adhesions, and our body tries to break down the mesh to get rid of it……it;s for some of us a never ending, never healing wound subject to infections from being put in vaginally where it is impossible to be a 100% sterile field for surgery 

  • Lilgemini

    I awoke after the surgery so sick I could not even hold down ice chips and I was in so much pain and I was kept in the hospital for a few days however I was still hurting and after 16 months of continues bladder infections and throwing up on and off for a year and my Gyn/Ob said he could not find anything wrong and refused to give me any pain meds or nausea meds so I thought so many times of just ending my life because I was unable to preform my day to day chores , I ended up going to a gastric dr and he said it sounds to him like I was having gallbladder problems so he removed it and it made no difference in the way I was feeling so I even became more suicidal so my husband sent me to a shrink and I had to meet with him every week for over a year, then my husband started to researched all my symptoms and that is when he started to see I had the same sytoms as so many other woman and I called my Dr to tell him what we discovered and he said well I have not had any other complaints and so I told him to send me my records and I was going to get a second opinion , well I received my records in a week and he had a typed up surgical note stating that I came to him with bladder problems and he stated that I requested the bladder sling !!!! And he had told me the warning that came with this procedure and he listed the side affects on this letter and I was out ragged because #1 I was told that we were doing a bladder tact so I did not even know that I was having an object being put inside my body, I thought he was going just take 4 ott and lift my bladder tact it so if I would have know what he was going to do then I would have researched it and if I would have read up on this sling and with those complaints by other woman I would have never allowed this evil damn device to br placed in me so I am very pissed off with the company who made this thing and my Dr for lying in his notes ( to cover his ass ) and the FDA for allowing this death device to stay on the market. But thank God when I got a second option that dr said we have to take that device out of me before the sling did any more damage

    • Care Bear

      I hope you have lawyered up!!!! doctors and manufacturers need some stimulation to rethink their positions, and I hope you complained to the College of Physicians in your country….

  • Salzburg

    Thank you the article is informative, but the comments catch the biggest mistake: The FDA is relying on patients being their own best advocate. As a few earlier comments have already pointed out:
    The statistics are not available for everyone and lay people can not be expected to be medical experts. 

    The medical and pharma industry is profit oriented which is okay, but when things go a wire the system has failed. There is a point of recklessness. Producers need to be responsible to inform doctors of risks, and doctors need to inform patients. A reliable independent system needs to be set up and consequences of punitive form should occur for those who fail to inform or cover up. Including jail for the CEOs. It sounds harsh but women suffering is not okay.

  • Torieb

    The first tenet of the Hippocratic Oath is: Do no harm. Greedy doctors, investors and health organizations should be prosecuted for promoting surgeries and surgical devices that are known to be harmful to most patients. If it were simply an issue of the device and surgery used for the “appropriate patient,” there would be no issue; greed corrupted the process which was in place to protect patients. Clearly, the devices and surgeries were not used for “appropriate patients,” and that is the highest form of mismanagement and breaks the No Harm rule. They should be prosecuted, all who betrayed patients, all the way up and down the chain.

  • Joyce

    I am so thankful for this article.  My gyn said “Don’t get constipated”.  No sugary food is worth it, skip pain relievers too.  Hydrate, relax, move.  

  • Crystal Eberle

    Six months ago I had a very successful lift/repair with the Monarc mini-arc mesh at Women’s Speciality Care in Las Vegas, NV.  I am 100% satisfied and have had no complications from the 10 minute out-patient procedure.  My doctor, Warren Volker, is an expert in this type of procedure and is listed as a Uro-Gynecologist.  The skill and experience of the surgeon is the most important piece of this procedure.  

  • Virginia L. Carlson

    I had pelvic floor reconstruction surgery at Magee Women’s in Pittsburgh several years ago (2002).  The little mesh sling was highly touted at the time.  At the end of a very lengthy post-operative period time, the surgery was deemed a failure, because the mesh sling did not hold.  The surgeon said, “Sorry, the surgery was not a success.”  I’ve heard nothing from Magee Women’s since. I have since that time suffered from all of the symptoms that led to the surgery in the first place, except that now I have no uterus.

  • CitizenJane

    I’d like to see some mesh put in an intimate place where it might send a clear message to the money makers so keen to promote this method over safer less invasive treatments that have worked for women and their health.

  • http://pulse.yahoo.com/_D5NXEIHNU736XMGJ7R2MV6IITM C

    “Dr. Peter Rosenblatt, Director of Urogynecology and Reconstructive
    Pelvic Surgery at Mt. Auburn Hospital, a teaching hospital of Harvard
    Medical School in Cambridge, MA, was one of the surgeons who signed the
    letter. He says mesh erosion can be a “nuisance” but adds that for a
    minority of patients it is a serious complication. “The overwhelming
    majority of my patients are happy,” said Rosenblatt, who is also paid by
    Boston Scientific, one of the mesh manufacturers”.

    Just like that butcher on the T.V. series “Bramwell”. Who cares about the ‘minority’, whose lives are turned into a complete horrific nightmare – all is well according Rosenblatt.

  • minddoc

    As an almost-50 year old woman who had a hysterectomy at age 39, I was having both bladder and bowel prolapse and had this surgery in late September.  I stumbled upon the FDA warning about the mesh (the July one referenced in the article), and brought the article to my gynecologist who basically blew it off saying that he has done several hundred of these surgeries and not one woman has had a problem. I tried to find statistics – but things such as the trial they stopped early due to the number of problems with the mesh – were simply non-existent (at least to a non-physician). The “alternative” procedure discussed in the article (for younger, healthier women) was never mentioned to me or I would have considered it. Thankfully, I have had no issues so far and have to say that of all the women I know who have had the surgery (which is more than half of the women I know over the age of 50) have not had any complications. As a Clinical Health Psychologist, I try to have evidence-based data to support such a major decision – and I knew the questions to ask – but I was still basically blown off with “verbal” pats on the head that basically conveyed, “don’t you worry your pretty little head over this – it will be fine”. And I hope and pray it will be. However, there is clearly a problem with this surgery and it is nothing less than frightening (and infuriating) that we are not told of the real risks of the surgery in clear, plain and easy to understand language with statistics that we can also understand (such as “X number of women out of 100 will have these complications…”). Only when we are completely informed – with ALL of the information, risks, complications, etc., – can we truly provide “Informed Consent”.  And it all comes down to money…

    • Amyslc

      Sadly, there are no hard statistics as reports are post-market, meaning it relies on patients, a layperson to report these events to the FDA through a very cumbersome and difficult to access system. Most surgeons deny complications attributing it to other things or marginalize it as “oh it is eroding just through the vagina.” Patients unable to get help from the surgeon who placed the mesh end up being managed by others, presently there is nothing to compel surgeons to report post market adverse events. So it is fair to say complications are grossly underreported. There should be clinical trials before a permanent device is implanted.  Suprisingly few surgeons are aware of the 510k process.

  • JSetla

    As an internal medicine physician, I am disgusted with how our drug and device treatments have been dictated by industry-biased or no research, followed by heavy marketing to physicians and the general public.  No patient could ever get proper informed consent in our present system. Frankly, nor could I even with my background. This is another example of how influential corporations have undue impact on the policy decisions by government and regulators, right down to what is placed in your body or sold to you in the everpresent drug ads on TV. This is another example of why I now support the Occupy Wall Street movement. This is not capitalism, it is massive corruption of a system that is supposed to protect the public.

  • Christine05

    It looks like a huge problem is non-expert physicians doing the surgery. This, as well as the product, ought to be regulated.  The Magee’s Women’s Center for Bladder and Pelvic Health, where my gynecologist was trained, requires the people trained there to be proctored on multiple surgeries, since the procedure takes a lot of finesse, to say nothing of the importance of screening for appropriate candidates. So one’s surgeon, as for any procedure, should be chosen with great care and research.  I was lucky to have very succesful mesh surgery over six years ago;  however, my anxiety going in today would be far higher having just read this article.  
    My heart goes out to the women who have suffered these horrible results.

  • Amygknits

    Before resorting to surgery, please consider a pessary. They are a highly effective, inexpensive, non surgical solution to uterine prolapse.

  • Elcee

    I agree that patients need to be informed self-advocates – as much as possible – but that’s not enough.  Patients have not undergone years of medical training, and it is very difficult to interpret this type of very technical data accurately.

    As Uwe Reinhardt said, “you can’t rely on caveat emptor [buyer beware] to police the market, because the emptor doesn’t know how to caveat.”

    • commonhealth

      excellent point. i totally agree. rz

  • amyslc

    Thank you for taking the time to research and report on this long and complicated history with transvaginal mesh. Until now few understood the complexities of politics within professional medical societies influenced by corporate greed and marketing. I hope other media outlets will follow your example in reporting news in the public’s interest.

    Also thank you Anne Weber, MD for trying to get the media to take notice. For those of us who have suffered and have been systematically marginalized by ACOG and AUA  members, your acknowledgement of our experiences as something more than a “nuisance” is most appreciated.

  • Marie

    Good article; very informative. Good advice you give: “patients must be their own most aggressive medical advocates.” This is so hard to do – how do you know when you have all the information you need? But a very critical step. We can just blindly trust the advice we are given. Good luck to all these women and thank you for sharing this information.