Avis Favaro- CTV News

So the network did a follow-up Tuesday, February 19.

Medical/Health Reporter Avis Favaro (background here) and producer Elizabeth St. Philip found more women speaking out to say they’re living in agony from transvaginal mesh implanted to treat pelvic organ prolapse or incontinence.

Many were suffering in silence thinking they were the only one.

It is the same basic four or five companies that make polypropylene mesh to treat U.S women that is also used in Canada,  and just like the U.S., Canadian women are having complications.

The lack of any solution is another problem for women in both countries.

As in the U.S., the problem in Canada is that there are few doctors who know how to treat women after they’ve experience a complication.

Removal is often suggested if the mesh migrates or perforates organs, causes infections or does pudendal nerve damage, but Canadian women went public last November (see story here)  saying there are few options for them and they wanted the Canadian government to pay for mesh removals at UCLA where Dr. Shlomo Raz appears to be having the most success in these difficult procedures.

The government denied the women’s request.

Ruth Olson

Saskatchewan resident Ruth Olson was one of the women speaking to her government.

She had mesh implanted in October 2011 during a hysterectomy after suffering with a leaky bladder.

Her pain began almost immediately.

“I had pain coursing through my body,” Olson told CTV News. “Burning pains through different parts of my body. It was strange, unbelievable and inexplicable.” Olson traveled to Los Angeles to have the mesh removed.

The surgery at UCLA costs about $30,000. Dr. Raz and his urology group at UCLA have reportedly removed mesh from around 500 women with a waiting list of women from around the world.  CTV reports:

“However, some Canadian doctors are surprised that women are going south of the border. Dr. Jacques Corcos, a urologist at Montreal’s Jewish General Hospital and a professor of surgery at McGill University, said he and other surgeons in Canada are capable of treating patients suffering with complications from the mesh, and is “surprised” at suggestions to the contrary.

“I think each province in Canada has sufficiently well-trained physicians to do this kind of work,” Corcos told CTV.”

See the rest of the story on CTV here:

And be sure to add your name to the comments below the CTV story, which the television network will see. The more the media sees this story hits a nerve (sorry for the analogy) the more they will see the wisdom in covering this important topic. [Editorial comment *ja]

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Dr. Ronni L. Seltzer, psychiatrist

January 30, 2013 ~ On this half day of trial in the  Linda Gross v. Ethicon case being heard in an Atlantic City courtroom, psychiatrist Dr. Ronni Seltzer was on the stand. She conducted two evaluations of Linda Gross and determined the focus of her life, along with her husband Jeff, is pain that permeates every aspect of her life.

Thanks go out to Courtroom View Network for the live feed.

Pre-surgery Linda

Before her surgery to have the Prolift transvaginal mesh implanted Dr. Seltzer determined Ms. Gross was a “dynamic woman” who loved her job. Her  family is very important to her, said the doctor. She has three adult sons and young grandchildren.

Outdoor life was important, especially since she had three boys, surmised the medial doctor/psychiatrist.

“She opted to have surgery so she could improve her quality of life,” she said.

Linda Gross had an Ethicon Prolift transvaginal mesh implanted in July 2006. She claims the defective product has caused her permanent harm both physically and psychologically.

Pre-Prolift she did not have a depression history, according to Dr. Seltzer. She did have some physical problems though.

Ms. Gross had a hysterectomy in 2001 which was followed with excessive bleeding and stress incontinence. She had spinal anesthesia which caused a tear in the dura, a complication of spine surgery where the covering over the spinal cord is nicked by the surgeon’s instrument.

It resulted in nine months of spinal headaches. She needed three blood patches to address the headaches. When the spinal pain abated it turned into migraine headaches for about nine months. She was treated and that pain ended in March 2002 and has not returned.

David Mazie, Mazie Slater Katz & Freeman

David Mazie asked if Ms. Gross’ pain were to suddenly go away today, would her depression, feelings of hopelessness and anxiety?

Dr. Seltzer said, “When  you’ve had pain since 2006 and gone through this experience it alters your sense of security in your environment. The symptoms might lessen but the syndrome is permanent. The pain takes over one’s life and its very easy to develop depressive symptoms.”

Post Prolift

Prolift, Medtech Marketing

Dr. Seltzer recounted a very sad story of Linda Gross’ life today.

Initially after surgery in July 2006 she was fine but problems with pain would wax and wane. As they became more intense and permanent she developed depression symptoms related to the pain and anxiety- not knowing what was happening or when it would occur next.

There was an evolution in her mood. Sleep became attainable only with medication, and even then she got no more than four hours a night.

As she had to reduce her work hours due to the pain, she gained weight from overeating to compensate and withdrew socially from both friends and co-workers.  She felt guilt toward her family that she was not able to enjoy things as she previously did. Ms. Gross was not able to maintain her household, play with the grandchildren or be intimate with  her husband.

Dr. Seltzer described anxiety that followed each of the 55 medical procedures she experienced. After one procedure there was a problem with breathing that forced her to use a C-Pap.

“She rallies, then there is a payback,” Dr. Seltzer said, describing her youngest son’s marriage in 2012. Linda showed up for the first dance with her son and had to miss the rest of the festivities. She had to rest for the next several days to recuperate.

“She feels sad this daughter-in-law will never know her as she had been,” Dr. Seltzer testified. She also described feelings of worthlessness, and ruminations – repetitive thoughts about what happened to her and all of the things she lost.

Mazie asks, “Did you reach a diagnosis what she suffers from?

“Yes. There are three psychiatric diagnosis I reached – she suffers from pain syndrome due to the ramifications of the mesh but due to the pudendal neuralgia, due to complex regional pain syndrome in the nerve fibers in that region, it has caused dyspareunia, an  inability to be sexually active.”

Pain is the primary focus of her life which in itself can cause psychiatric symptoms such as pervasive anxiety about things she has no control over, Dr. Seltzer said.

Dr. Ronni L. Seltzer, psychiatrist

“Depressed mood , insomnia, overeating, fatigue, feeling hopeless, worthless, and unrealistic guilt on the impact it has on other people. When she is at her lowest she has not had thoughts of suicide, she has had thoughts – Is is this worthwhile? Would I be better off dead?”

With such a picture painted, the cross examination by Kelly Crawford had to be sensitive but sometimes became combative with Dr. Seltzer.

 

 

Cross Examination

Once again she established for the jury that Dr. Seltzer was testifying and had done her evaluation for compensation, about $35,000 so far. Crawford tried to establish that the psychiatrist spent half of her professional life testifying in trials but Dr. Seltzer shot back that was a typo in the deposition, she did NOT spend half of her time involved in litigation (the “not” had been left out of the deposition).

Dr. Seltzer said she has a very active practice as a psychiatrist in Englewood, New Jersey and begins her day at 7:30 am seeing patients all day until she stops often not until 8:00 pm.

Crawford established the doctor is not a urogynecologist and has no experience in mesh used in pelvic floor repair.

Because Linda Gross chose biofeedback and physical therapy to address her headache pain, Crawford tried to indicate she did not choose psychological counseling, as if to imply she did not seek help for her mental state.

Crawford asked if Dr. Seltzer understood Linda Gross had three difficult births, problems defecating and problems with her pelvic floor pre-Prolift? The two got into some semantic wrangling over whether or not the doctor had fully explained that she did not examine Ms. Gross in person.

Crawford also established that a person-to-person evaluation is preferable if possible for diagnostic purposes but it was clear that during her deposition of Dr. Seltzer, Crawford was not aware until the 14th question that the evaluation had been over the phone.

Following a lot of back and forth it became clear that a  “personal” evaluation is a professional term differentiated from a review of the records and can include a phone evaluation.

As far as her ongoing pain, Crawford did not sound sympathetic when she indicated the Mayo Clinic’s pain program, which Linda Gross is scheduled to visit in March, has an 80% success rate.

Q: “At the Mayo Clinic 80% have greater control over their pain and lesser depressive symptoms. You factored all of that into your evaluation that she is permanently depressed?”

A: “It can improve the quality of life but it doesn’t take away the reality of their pain. Fear, anxiety and depression is permanent.”

Crawford had Dr. Seltzer read the guidelines from American Association of Psychiatry and the Law about the importance of having a personal evaluation. She read, “Being retained by one side exposes psychiatrist for unintended bias and unintended distortion of their opinion.”

Despite an objection, attorney David Mazie came back to establish an earlier point. “When did she have any record of urinary retention from the records?”

A:”It was after the Prolift mesh surgery. Thank you.”

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Dr. Piet Hinoul, Ethicon Medical Affairs

January 16, 2013 ~ The worldwide medical director of Ethicon took the stand all day in the trial of Linda Gross v Ethicon in an Atlantic City courtroom. The past president of the Flemish Society of Obstetrics and Gynecology from 2007 to 2008, Piet Hinoul had become the Director of Medical Affairs at Ethicon, a division of Johnson & Johnson that planned to bring the Prolift mesh to the market.

Much thanks to Courtroom View Network for the feed which allows for these images to be captured and audio to be logged!

Prolift is the mesh implanted in plaintiff Linda Gross in July 2006 after suture repairs had failed to hold up her falling pelvic organs following a hysterectomy.  Almost immediately she was in intense pain which continues to this day. She must self-catheterize to pass urine three to four times a day, cannot sit for any time, and has had to give up her job as a hospice nurse. Gross has undergone 22 surgeries since the mesh was implanted, nine of which were mesh removal operations pieces of which were found around her body.

Her doctor believes she is permanently disabled.

Gross is suing Ethicon over what she calls a defective product and a failure to warn doctors about the dangers of mesh. She received a Prolift, an innovation in pelvic floor repair that came pre-cut in a kit with delivery and retrieval tools.

Adam Slater, attny for Linda Gross

During the fifth day of her trial, attorney Adam Slater attempted to show that there was dissent within the company questioning whether the Gynemesh PS was the best mesh material  to use in the new Prolift launch.

Project Lightening

When Prolift was finally marketed in March 2005, Slater showed company internal documents that scientists within Ethicon were already working on replacing the Prolift’s Gynemesh PS (soft prolene) with another mesh, possibly the UltraPro.

The search for a better material was called Project Lightening.

Two months after Gross had the Prolift implanted documents show scientists were asking for a clear definition of erosion. The ideal mesh was 75 microns or less so the mesh would allow for blood vessel ingrowth and collagen fibers to grow into the mesh and cause the desired amount of fibrosis, but not too much.

A graphic shown to the jury said more than a year after Prolift was launched the company sought out customer complaints and a way to reduce the sexual functioning issues associated with the Prolift. They were looking for a “Quick Hit” modification to existing product, likely the Ultrapro.   Hinoul took exception to the term “quick hit” adding that the Prolift had taken four or five years to make it to market.

In a power point presentation an Ethicon expert meeting June 2, 2006 had some of the leading experts in mesh gathered in Norderstead, Germany to talk about mesh. A project planned down the road would be called Thunder, as the group searched for the “holy grail” of pelvic floor repair mesh materials, said Slater, with a new weave to match the tissue properties of native tissue.

Project Thunder was ahead on the horizon to be developed in later 2008 or early 2009 as Ethicon sought out the perfect mesh. The list of high priorities underscored a perfect mesh. The group was looking for a mesh with no shrinkage and no long-term contraction, no fibrosis, no scar tissue, dyspareunia and no folding of the mesh.

Hinoul characterized it as a quest for excellence.

“It’s a goal to have a better process, it’s a continuous process. We’re always testing, seeking what we can do next. These meetings are frequent and we invite all kinds of people whose opinions we respect” he told the jury.

According to Professor Klosterhalfen, considered an expert on mesh, the biological responses to surgical mesh continued to be a concern.

The huge surface area of meshes included more than 300 meters of suture. “Even after 20 years the tissue is still reacting to the mesh,” said his note indicating a foreign body reaction.  And “Fibrosis is responsible for complications in mesh usage, there is less fibrosis with Vypro compared to polypropylene.

Mesh Shrinkage

Polypropylene (PP) mesh

One of the critical elements of mesh complications was the pore size. Hinoul told the jury a pore size of 75 microns allows for blood vessels to grow into the mesh and for the needed scar tissue. But the trick was for the company to balance a minimum amount of fibrosis to give the mesh enough strength to do its job in creating a scar net of fortification. The downsize of the smaller mesh is fibrotic bridging and mesh shrinkage.

Some patients were reporting bridging and pain after their mesh implants and the company was talking about that internally. Dr. Klosterhoffen reported that even a 20% shrinkage of mesh could reduce the mesh size by 64% causing the woman to experience pain. Women were experiencing mesh erosion and shrinkage with the Gynemesh PS, the same mesh used in the new pre-cut kit known as Prolift.

But on the stand Slater asked Hinoul whether there was any way to predict who would react to a 64% mesh shrinkage and who would experience an inflammatory reaction to mesh.

Slater:  “There is no way to know who is doing okay and no way to know who ends up with more pain and complications right?

Hinoul: “Overall you’d expect an acceptable scar.”

Slater: “That was the hope?”

Hinoul: “We knew,” Hinoul said with great assurance.

Hinoul added that luckily conditions that would lead to debilitating injuries and invasive surgery to remove mesh were very rare. Slater asked if Hinoul was aware of data that showed a 19.6% painful contraction rate for the mesh.

Hinoul: “Contraction with pain, I think we have to qualify that 19% I’d like you to show me those papers and numbers.”

An internal company power point presentation addressing the subject of shrinkage more than one year after the Prolift was launched also confirmed small porous mesh 1 mm or less were believed to offer less fibrotic bridging and increased shrinkage. Large porous meshes allow for better and faster tissue ingrowh and less shrinkage.

Hinoul said the Prolift was 2mm or more in pore size, but Slater asked, “There is no distinct pore size in Prolift mesh?”

Hinoul:”I don’t know.”

Slater: ”The hole openings vary in size and are not distinct in size and they are irregular.”

Hinoul: “I would not say that. It’s a textile, they seem to be the same.”

Even Dr. Michel Cosson, one of the French scientists working on the new transvaginal mesh said in an email polypropylene might not be improvable in terms of shrinkage, we may need a completely new material.”

By the afternoon, Slater showed a deposition that further exposed what the company knew and when it knew it. Playing a prerecorded deposition of deposition of Gene Kammerer, an engineer and Principal Scientist at Gynecare/Ethicon.  

Two months before the launch of Prolift, Kammerer wrote an email to the Gynecare Marketing Group to see if there would be any interest in funding an exploration of using the, “UltraPro mesh for pelvic floor repair in place of the Gynemesh. I think this could be the next advancement for pelvic floor repair. Without going into too much detail here, I will just say that this mesh could reduce the scar contraction and lower the density of the scar formation resulting in fewer cases of recurrence of the prolapse and erosion.”

Professor Kammerer

Kammerer felt the UltraPro created a more stable matrix and exhibited lower inflammatory response especially in the early stages after implant up to six months. Besides the UltraPro was more absorbable and left behind less material than the Gynemesh.

Regardless of all internal questions, Prolift was approved for market in March 2005 though Ethicon never sought or received U.S. Food and Drug Administration approval until three years later.

By February of the next year, Kammerer again wrote to Quentin Manley, a VP at Ethicon reminding him this would be an excellent opportunity to once again to check in with the consumers and to prepare to work on the “next generation of mesh.”

The UltraPro could control and reduce scar contraction and “we could get an enhanced product. The team wanted to move forward, then everyone got reassigned and the project went into limbo,” he said in his deposition.

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Pat Buchanan from KING TV

November 25, 2012 ~ Last June, mesh victim, Pat Buchanan was visited in her Seattle apartment by a television news crew from KING-TV.

They filmed her going through her triathlon gear which she had shelved after she began experiencing synthetic mesh complications in 2011.  The story is here.

One week later, Buchanan would be going under the knife for the second of two mesh removals at the capable hands of UCLA urogynecologist and surgeon, Dr. Shlomo Raz, regarded as the top doctor for mesh removals in the world.

Mesh Medical Device News Desk (MDND) prepared a Patient Profile of Buchanan last January (here)  where she talked about the triathlon she had to quit in 2011 because of the pain.

Today, after two mesh removal surgeries at UCLA, Buchanan is out of the excruciating, debilitating pain and is not only able to stand, but is able to walk up to six miles a day. However, running triathlons still eludes her, at least for now.

Buchanan’s Long Hard Road

In 2006, after testing positive for a gene mutation, Buchanan had a hysterectomy and her ovaries removed. Doctors put in two synthetic meshes. A Bard Marlex was implanted through the abdomen to correct a prolapsed vaginal canal (POP), and in a separate surgery, a Monarc (American Medical Systems) Subfascial Hammock was used to shore up her bladder and urethra as a treatment for stress urinary incontinence (SUI).

Abdominally-placed mesh to hold up the bladder and/or urethra, results in fewer problems said an expert panel meeting before the FDA in September 2011. Buchanan wonders if that’s because doctors do fewer of them.

Regardless, there is no FDA warning that mentions abdominally-placed mesh and legally those cases appear to be on the back burner to the transvaginally mesh placement lawsuits. Buchanan says she wonders where that leaves those patients who, like her, have had both types of mesh implant.

The Worst Pain I’ve Ever Felt

Pat Buchanan, from KING-TV, Seattle

By the time Buchanan went in for her first surgery in October 2011, the long distance runner couldn’t stand for more than 15 seconds.  She was wheeled into UCLA for her first removal surgery of the Marlex mesh.

“The pain with those is intractable, that pain you can’t get rid of it. It is you just can’t function; it’s indescribable, literally I just couldn’t face another day of that pain. By the time Dr. Raz had a cancellation I wanted to be euthanized. We don’t treat dogs that way.”

“I feel so fortunate because getting a hold of the patient advocates. They helped me get into see Dr. Raz and gave me a plan. I had been fumbling on my own while doctors said it was not the mesh. I thought I was dying and nobody seemed to care, or admit to it. I was up at night shaking from the pain and infection. Nights were hell,” Buchanan says today.                                                

Besides pain Buchanan was experiencing autoimmune reactions, pneumonia, allergies, canker sores, fatigue, and headaches.

“I’m an extremely healthy person and felt like I was falling apart. There wasn’t a single doctor who would believe that the mesh had any correlation.”

Dr. Raz found synthetic mesh had sawed its way through Buchanan’s vagina and adhered to her colon and embedded in her sacrum causing neurological problems.   A portion of the mesh was infected and adhered to her spine. In a major surgery, Buchanan was opened up from the abdomen to each hipbone. Dr. Raz had to slice between the mesh and the colon to remove the Marlex and reconstruct a portion of her vagina. She says he is as certain as anyone can be that the Marlex was removed.

In the past, doctors had tried to trim the mesh through the vagina which just makes it more difficult to find and remove by the next doctor. Buchanan says before Dr. Raz, no one wanted to talk about removing it.

After her October surgery, Buchanan had an immediate relief of the abdominal, pelvic, and leg pain, but the symptoms remained in the right foot which felt like it was an arthritic claw.

Second Surgery Last June  

Buchanan scheduled the Monarc mesh removal for June 29 in a separate surgery since Dr. Raz cannot perform abdominal and transvaginal surgery at the same time. Buchanan had the Monarc mesh removed and her bladder lifted with permanent sutures as well as a rectocyle (rectum and vaginal wall prolapse) and cystocele (bladder and vaginal wall prolapsed) lift with sutures.

As of today, Buchanan says she is rid of the pain from the mesh but is still having problems such as a rectal fissure, allergies, though not as bad, allergic headaches, and she is not totally continent. She says she cannot empty her bladder without standing up.

But physically she’s almost back. “I was able to take the stairs almost from the get go. Up three flights, no elevator. I’m a fast healer after having been in such good shape. It helps everything.”

Thankful

But overall she says things have improved so much she was truly thankful this Thanksgiving. This year she could walk, pick up her granddaughter, and cook.

She will seek more help for the ongoing pain in her urethra, and a fissure in her rectum, but for this athlete to go from not being able to stand up to an hour-long spin class, core work, crunches, and walking up to 6 miles a day, Buchanan is content, at least for now.

Her COBRA insurance ends in ten months and Obamacare for adults with preexisting conditions doesn’t start until 2014. Buchanan says the upshot is that she’ll be uninsured for at least a year.

She talks about mesh to whoever will listen and hears stories she wishes she didn’t.

Pat Buchanan, from KING-TV, Seattle

“A doctor tried to sell mesh to a friend of mine’s 82-year-old mother a few days ago by telling her that there’s ‘bad mesh and good mesh.’ When will this insanity stop?” she asks.  #

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Teresa Hughes and police officer, London

Teresa Hughes, 61, a resident of Liverpool, England, and mother of two, has made so much noise about defective vaginal mesh that last year she was profiled in the UK paper, The Daily Mail.

It started:

“Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems following childbirth. As a result the NHS is now facing a crisis on a par with the compensation claims for leaking silicone breast implants in the Nineties.”

In the Beginning

Hughes is one of an estimated 64,000 women living in England who is living with the aftereffects of an implantable plastic sling medical device. After undergoing a hysterectomy and experiencing stress incontinence, something she describes as, “nothing really bad,” Hughes says she was offered a transvaginal mesh tape (TVT) as a treatment. The polypropylene plastic mesh is inserted through cuts in the groin area to place the hammock-like support for the urethra to treat the incontinence.

In April of 2006, Hughes had a Boston Scientific Halo Sling implanted.

“They said I was a candidate for this tape for stress incontinence. That was it, nothing else. There was no discussion as to it being made of polypropylene mesh or that it becomes part of you and embeds itself into the body.”

Was she told about the risks?

“There is nothing on my record and they never mentioned that at all,” says Hughes today.

Right after the surgery she began having problems. She says as she came to, she was hurting, especially on the left groin. Crying from the pain for days, the pain would travel to the calf of the left leg. Hughes describes the pain as a “cheese wire” effect because it felt as though she was being stabbed internally.

After being discharged, the pain continued in the left groin along with a cramp in both legs and pain in the calves of both legs which continues today.

Mesh Complications

Teresa Hughes

Hughes and others have found that no one is monitoring mesh complications either in the U.S. or the U.K. Estimates from studies show complications may run as high as 20 percent in the short run from the mesh disintegrating, migrating, or forming fistulas, to causing a systemic allergic reaction to the polypropylene material. No one has studied the long-term effects.

Hughes returned to her doctor for pain in the groin and leg, then her own general practitioner who gave her quinine tablets. She received a diagnosis of appendicitis, which, it turns out, wasn’t true.

Then in September 2008, Hughes was shown a scan that revealed a mass in the bladder. Her local hospital did a biopsy and in November 2008 she was told she had bladder cancer because something had entwined around her bladder neck. She was asked if her bladder had ever been sewn up? She said she’d had transvaginal mesh tape implanted in 2006 to treat incontinence.

The cancer specialist left the room quickly she says.

It turns out she didn’t have cancer, but it was a foreign body.

Hughes asked the consultant urologist if he would send her for a second opinion; he declined her request.

Hughes asked once again and asked why he wouldn’t help her find another urologist for a second opinion. The consultant urologist replied, “Why should I help you,” she says today. Hughes told him she was in pain and needed help and she told him that she thought it was the transvaginal mesh that was causing her pain in the groin. She asked also to be referred back to the original gynecologist who inserted the mesh sling at the same hospital to have a chat with him about the symptoms she was experiencing. This was declined as well.

So she turned to the internet.

Medical Treatment in England

Hughes receives her medical services under the National Health Service (NHS) of Great Britain. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices are safe and effective, not unlike the role of the U.S. Food and Drug Administration (FDA).

Under the NHS, the public is not charged for medical services unless they seek out a private consultation.  Patients under the NHS have a right to their own medical records for a fee and also the right to a second opinion.

According to Hughes, the latest NHS figures also show the number of affected women is rising by more than 500 a year, indicating that about one in 20 of the 13,500 operations a year to implant the polypropylene material goes disastrously wrong.

Hughes says after the TVT scandal broke a year ago, government regulators agreed to a safety review of the product, but the results have been delayed.

How is Mesh Approved in the UK?

The U.S. Food and Drug Administration’s (FDA) allows most medical devices to enter the market with an assurance the device is the “substantial equivalent” of another similar device already being marketed. With the “substantial equivalence” stamp of approval, a manufacturer does not have to conduct clinical trials. The 510(k) notification process (manufacturers notify the FDA), as it’s called, is an honor system where the public and FDA must trust the ethics of a manufacturer not to put a defective device on the market.

Unfortunately, as the public has discovered from defective metal hip implants, defective silicone breast implants, defibrillator leads, and now transvaginal mesh, that hands-off approach to regulation leaves a huge safety loophole that many trusting patients fall through.

To approve a medical device in Europe, a device manufacturer seeks approval through any one of about 70 decentralized “notified bodies” overseen by for-profit firms. Any one of the bloc’s 27 member nations can approve a medical device for market. (See background story here).

Like the U.S., the EU has a hands-off approval process that failed to detect the Poly Implant Prothese (PIP) breast implants, a major health scandal in Europe as the unsuspecting found their leaking implants were filled with industrial silicone.

Now the EU says it wants tougher rules for the approval and post-approval monitoring of medical devices. After that global embarrassment, last September, the EU health commissioner outlined a draft proposal to identify medical devices that might be considered high risk and put them though greater scrutiny.

The European medical device industry lobby, Eucomed, was unhappy with that proposal.

As is in the case in the U.S., the UK does not follow patients with implanted medical devices after their surgery as part of post-approval monitoring. Nor does it register medical devices so any early signs of failure can be more quickly identified.

It was Australia, which does have a device registry, which was the first country to identify a problem with the Johnson & Johnson’s DePuy ASR metal hip, which was recalled from the market because of an early failure rate.

Teresa Hughes

Meshies United Group – UK

To raise the profile on vaginal mesh injuries, Hughes formed the Meshies United Group – UK ( here), and on January 26, 2012, she delivered a petition to the Prime Minister’s residence at 10 Downing Street to ask for help for the women suffering serious complications following transvaginal mesh surgery.

A meeting followed with her Member of Parliament who asked the government to reveal the number of mesh implant and explant surgeries over the last eight years.

The Medicine Health regulator in the UK did not have the answer.

“I am ashamed to live in a country that cannot keep track of serious complications of a medical device that has been implanted and causing so much havoc and ruining thousands of women’s lives and to be told that the Medicine Health Regulator does not know of the statistics,” the petition says.

Her findings which she received back from her representative in Parliament, suggested there have been nearly 3,000 mesh removal operations within the National Health Service hospitals. They do not include Northern Ireland, Wales, and Scotland, all part of the United Kingdom. Nor do they include statistics on any operations that have taken place in the private health sector.

The Medicine Health Regulator UK showed from 2006-2011, a total of 107 adverse incidents resulting from transvaginal mesh removal complications. No data was collected before the year 2005.

Hughes protests outside hospital

Hughes adds that surgeons are allowed to volunteer an adverse incident or complication event to the MHRA UK. She believes the real numbers are many times larger.

“Many women have lost their jobs their homes and some have lost their husband or partner. Their sex lives have changed forever in fact many women do not have a sex life because of the erosion and damage caused by the mesh.

“Men have also been affected because the mesh has cut their private parts. Some women have died and others wish they were dead because of the amount of pain they are in.

“General Practitioners do not know how to deal with this situation and many women who contact their GP for help are being referred to a mental health team because their lives have fallen apart.

“Would you like to be maimed for life by this barbaric operation? Hughes asks.”

Lawsuits in the UK 

In the U.S. most of the more than 10,000 lawsuits filed against nine mesh manufacturers are done so on a contingency arrangement with lawyers. The plaintiff pays nothing unless the lawyer wins her case at trial or she receives a settlement. At that time, she pays a percentage of her award to the law firm that represented her.

In the UK, there is no contingency fee arrangement. In mesh cases, solicitors, as lawyers are called, are asking for money upfront. Hughes says one firm in London, is taking cases but wants £600, close to $1,000 a month to start. Other solicitors turn to conditional fee agreements, where the plaintiff pays nothing if they lose the case but a full fee plus if they win.

“People don’t have that money they lost their job they lost their homes.”

Even with these drawbacks, hundreds of women in the U.K. have come forward to file lawsuits against the four major U.S. manufacturers of synthetic transvaginal mesh.

What incenses her is that doctors still put in vaginal surgical tape every day. She takes calls from women suffering all around the United Kingdom and says doctors are still not telling patients about the serious complications and neither are health regulators.

Hughes has campaigned tirelessly since 2008 to have the Department of Health and the Medicine Health Regulator UK to look into the serious complications of trans-vaginal mesh. On two occasions she demonstrated outside of The Medicine Health Regulator headquarters in London.

At the time she said, “We will no longer suffer in silence anymore. We want answers and we require help and it is about time people sat up and listened to us.”

Hughes is facing more surgery ahead. University College Hospital doctors plan open surgery on her to find the mesh and repair the urethra and bladder neck, but it may take a series of four surgeries. A recent emergency gallbladder removal has delayed her mesh removal surgery.

She has been granted a meeting for November 15, 2012 in Brussels with the Director of Consumer Affairs on behalf of her support group, Meshies United Group UK.

Postscript* Hughes says she is writing a play about the nightmare of mesh. Her brother is a producer in Liverpool.

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Oct 31, 2012 ~ 

“It is just so important that a woman knows what exactly is going to happen to them during a hysterectomy.  No one usually explains that you lose your support for your bladder.  That is why these TVT kits were invented in the first place I think to be an easy “fix” to the issue. No one explains the alternatives.  There are so many options for SUI and POP.  It is interesting now that I am at the proper doctor just how much you learn.  The kits have too much risk of complication as we know. Lives are devastated with too much pain and suffering to bear.  All aspects of your life is affected.

“Now if you have been injured by the mesh you have to be extremely careful to get the right help or your condition will only get worse.  Using the right words with your doctor can make all the difference.  “Mesh” means something different to doctors than “Entire Device”.  We have learned all too well that leaving parts of it in causes future havoc.  Women get a little relief at first but things eventually get worse.  Some women do not have a choice if it has eroded already.  That does justify a partial removal if it is cutting into you.  But never let a doctor remove it if they are not skilled to do so.  If they think it is too dangerous, there is your first clue.  You deserve someone who knows how to safely remove it verses someone who does not have the experience.

“Once your mesh is removed, you are so relieved to think the hard part is really over but now comes part two of the nightmare when you realize just how much your Tissues, Nerves, Muscles and Ligaments have been injured by the MESH.  Repair and Reconstruction may be necessary.

“Prolapses may have occurred and that is why you are still having issues.  It is not your fault!!!!   All devices are a little different so this topic may be different for everyone.  Of course a skilled surgeon will do as much repair at removal but we can have so much damage from the mesh that you need to heal between surgeries. You will know how you are doing once you are physical again.  It takes time. I feel surgery works best if removal and reconstruction are separate surgeries.  So if you do require more help, this is where your patience really needs to come in.  There are many options available for this part of the recovery.  We all are paving the way for women to get the help they need in this regard.  But there are ways to repair/reconstruct not using mesh.  At least that is good news.  We are also trying to learn what to do about the nerve damage.  Hope to have more to report on that in a future update.

“You can get your life back.  Just know you are not alone.  The uncertainty we face can create so much anxiety. We have to believe that things can get better.  Not perfect someone said once said but better.  It is true.  Just please do not give up!

“Love and Prayers to you all………”  #

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I understand and often feel the same way. The public doesn’t think journalists have standards but there are very strict standards for the best journos and I believe he is very good.  But I insisted, I’ve flown myself to the FDA hearings, I’ve been following the issue since 2009 and am truly interested in the topic and feel it’s an important story of our time. I’m not soliciting for the attorneys, they just offer some support! Do I have to take a vow of poverty to be a journalist? The New York Times takes ads for BMW, does that mean there is a conflict? I was getting a bit flustered and I’m afraid it showed.

It fell on deaf ears – any association with lawyers is a conflict. Some other journalist will have to do the story.  Maybe they could interview you, he said.  Right.

Sometimes you can’t catch a break.  Anyway here is the story I did. Too bad they won’t read it in In These Times.

###

The email came in on February 21, 2012. It said “Please Help Me”

Okay I thought, this is a scam. Someone crying that their funds are tied up in a Ugandan trust and they need me to forward cash. Right.

But lately I’ve heard from too many people who are desperate for answers because they are in severe pain following a common medical procedure – the implantation of synthetic surgical mesh to treat hernias in men and women and pelvic organ prolapse and incontinence in women. So I clicked.

“Jane, I am sitting in a hotel room here in Washington DC.  Flew in from far west Texas to see a doctor to consult about mesh removal for my mom. This doctor was highly recommended.   My mom is in such pain and has been for two years…the flight alone was hell.  She was a very active woman prior to having this put in her.

This was a waste of time and money as the doctor here acted like this was no big deal and referred us to some urogynecologist in Albuquerque.

Jane, I don’t know what to do.  I have never seen my mom cry like this.  I have never seen her so weak and scared.  No one in my web research will say with clarity who to trust.  I am flying back home tomorrow with my mom and I am more confused than ever. My mom is saying things like “I just give up.”

What do I do?  PLEASE PLEASE give me any guidance you can.”

The woman left her phone number and email.  Her mother turned up in a cursory Google search to be who she claimed. I called the daughter.

There are thousands of men and women living in debilitating pain from permanently implanted synthetic petroleum-based surgical mesh. Turning to me as an option shows just how desperate these people are. I’m not a doctor or a lawyer but a journalist who began writing about mesh complications in the spring of 2009 after being contacted by a persistent mesh victim.

I couldn’t believe what I heard.  For some reason, in some people, mesh migrates and perforates organs, erodes into the vagina, can cause a systemic inflammatory response and intense pain all over the body. In men, hernia mesh has been known to entangle nerves and form a hard plastic ball. The actual complication rate is unknown even by the U.S. Food and Drug Administration (FDA).

The thousands of mesh-injured men and women are victims of a perfect storm – the aggressive marketing of the medical device industry paired with the hands-off regulation by the FDA toward medical devices which relies on the mesh makers for assurances of safety and efficacy.

And while I tell the stories of women and men who are injured by surgical mesh on my Mesh Medical Device News Desk (MDND) website, there is very little I can do to help. I don’t refer the injured to lawyers or doctors, despite receiving support from two law firms, but what I do, as I did here, is put her in touch with women and men who have gone through the same living hell and are now advocating for others.

Many who I talk to are bankrupt and without insurance. Others return to their original doctor only to be turned away with phrases like, “You’re the only one I’ve seen,” and to be given a prescription for an antidepressant.

Others begin a succession of specialist visits only to be met by a wall of resistance and denial.  In some cases, a doctor will attempt a removal only to leave the arm of the mesh behind which often leaves the woman in worse condition.

 “On return to the doctor who placed the mesh in me, he claimed upon re-examination that he could not find anything wrong. I suffer with excruciating pelvic pain on my left side radiating into my lower back spine left side. I’ve had CT scans, a MRI and can’t seem to diagnose anything. I can’t stand or sit for long periods or walk. NO one can help me. I’ve been to three different OB-GyNs with the same thing, we can’t find anything.”

A man told me his mother was in such pain from a mesh implant that she shot herself to end the pain.

HOW DID WE GET HERE

An estimated 13 million American women experience stress urinary incontinence (SUI), a leak of urine that can happen during a sneeze, laughter or physical stress. It’s estimated about 20-40% of women have some form of incontinence.

Pelvic organ prolapse (POP), involves the decent of pelvic organs, the bladder, urethra, small bowel, rectum, or uterus, through the vaginal vault due to weakness of the connective tissues due to multiple births, age, hysterectomy, menopause and injury. Some experts feel we inherit the collagen which makes connective tissues and muscles strong. Exercise, or the lack of, may play a role.

Except in rare cases, POP is a nuisance but not life-threatening and many women are asymptomatic. The condition can be maintained by using a pessary, a rubber insert that holds back descending organs, making lifestyle changes, and through surgical intervention to stitch up the anterior or posterior vaginal wall.

Surgical mesh was first used to repair abdominal hernias in the 1950s, but fast forward to the 1990s and fuelled with aggressive marketing pushing a host of new petroleum-based materials, gynecologists began using synthetic polypropylene or polyester surgical mesh, some delivered in precut boxes, to hold up the urethra or the vaginal vault.

The FDA reports about 300,000 U.S. women underwent POP repair in 2010 with 75,000 of those procedures involving transvaginal (through the vagina) implantation of surgical mesh. And even gynecologists, many who were never trained as surgeons, can attend weekend cadaver training sessions offered by the major mesh makers – Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, and C.R. Bard to learn how to implant mesh in the blind procedure.

One woman told MDND her doctor said this new surgical option for his practice would be his “bread and butter.”

510(k)

“Biggest regret of my life, as it has ruined my life, my sons childhood, and my hysbands and mines marriage. Its truly a living hell. ~ 25-year-old implanted with mesh after a hysterectomy.

Most Americans assume that medical devices undergo the same sort of scrutiny as pharmaceuticals, but they would be wrong. Ninety percent of the 4,000 medical devices approved for market by the FDA every year do not require proof that they have been clinically tested for safety and efficacy.

Instead, they are approved under the 510(k) process –a fast-track system that’s an approval for marketing. Device makers like the relative low cost and ease that can bring their device into the marketplace after an exchange of paperwork.

Most of today’s gynecologic mesh can thank Boston Scientific. In 1996, the FDA cleared its ProteGen Sling for market which served as the ‘predicate,’ a device “substantially equivalent” to the new one seeking approval, required under the 510(k) process.

From 1992 to 2010, the FDA cleared 168 510(k) for synthetic surgical mesh for urogynecologic conditions, many which named the ProteGen as  predicate. But there was a problem.

ProteGen was recalled in March 1999 for being defective, “adulterated and misbranded.” But there is no trigger within the FDA to initiate a re-review of all of the devices that had named the defective ProteGen as a predicate.

The FDA reports in 2001 the number of clearances per year doubled and increased another 50 percent the following year.

And so did the complications.

By 2011, the agency reported 2,874 reports of injury, death and malfunctions from January 2008 to December 2010 associated with urogynecologic surgical mesh – a fivefold jump. Falling just short of a recall, a Public Health Notification by the FDA in July 2011 warned of the risks of mesh.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. 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.”

DOCTORS ON BOARD

Daniel S. Elliott, MD, Assist Professor of Urology at the Mayo College of Medicine in Rochester, MN specializes in female urology and pelvic organ prolapse. He told MDND that the Mayo Clinic refuses to use mesh for transvaginal POP repair because it carries more risks than added benefits.

“On a weekly basis, either I or my colleagues evaluate and treat patients suffering from the consequences of the non-absorbable mesh kits. The diagnoses run the gamut of mild vaginal erosion (or extrusion) to devastating urethral and/or bladder erosions with severe, debilitating, life-altering chronic pelvic pain. The patients have suffered needlessly because the standard POP repair without mesh, in properly trained hands, is easy, fast, and effective, avoiding the unique complications associated with non-absorbable mesh kits.”

Dr Elliott has joined Public Citizen in calling for a complete ban on synthetic mesh until multiple independent, non-industry supported research can show any benefit.

“Anything less would be surgically irresponsible and ethically unacceptable.”

SUFFERING IN SILENCE

One woman, who does not want to be identified, had a professional life including a waterfront home in Florida, a successful business, and a nice car.  When she went in for a hysterectomy, she mentioned to her doctor she sometimes suffered from incontinence.

Her doctor told her not to worry. He said he had a new tape and she’d really like it. She was implanted with the  Ethicon TVT Prolene polypropylene mesh.

Thirty-six hours after being released from the hospital she was back with a raging flesh-eating infection which almost took her life. Shes undergone nearly 20 surgeries since for infection and mesh removal.  She points out that the mesh package insert says Prolene mesh may have to be removed because it can “potentiate an infection.”

Dr. Donald Ostergard has published reports that say mesh is not inert in the body. Produced with antimicrobials, adhesion preventatives and surfactants, it may be impossible to measure the chemical reactions between the polymer mesh and the human body which can lead to a host of problems including chronic inflammation and autoimmune diseases.

BREAKING THE SILENCE

A petition filed by Public Citizen last August joins in the chorus demanding synthetic mesh be recalled from the market and reclassified as a Class III medical device which requires premarket approval application (PMA) that includes data from clinical trials that provide a reasonable assurance the product is safe and effective.

Consumers Union in February of this year launched its Safe Patient Project  to urge more rigorous testing on all permanent medical implants before they are marketed and to establish some tracking system not unlike the VIN number on a car. At the present time there is no registry for medical devices.

Most people I interview for MDND don’t even know what kind of device they have until they start requesting pre-surgical notes.

At the present time, it’s easier to track a defective Toyota than a defective implanted medical device.

Like Public Citizen, Consumers Union wants to abandon the 510(k) process and to start some sort of post-surgical registry.

Rep. Edward Markey in his Sound Devices Act, wants to eliminate the use of a predicate device like the ProteGen sling when it has been found defective. Rep. Henry Waxman is requesting the House Energy and Commerce Committee hold hearings, but the requests are falling on deaf bipartisan ears concerned that the medical device industry may suffer in sales and innovation if the protests get too loud.

In an effort to catch up, last January, the FDA ordered 33 mesh manufacturers to begin collecting as much as three years of safety data on the implants.

FEW REMOVAL DOCS

“Mr. Hansen, I am tired.  I get up every day dealing with my own painful symptoms and then I read the stories of others.  It is too much for me and a tiny group of women to handle alone.  We need your help. 

I will hopefully have mesh removal later this year by the best and most experience surgeon in the world.  I will turn sixty-five in June and at last have Medicare insurance to see this doctor.  His name is Dr. Shlomo Raz of UCLA.  He knows the truth.  He is so booked up with mesh removal surgeries, that is difficult to get an appointment.

“Please Mr. Hansen. Help us.”

~Mesh Patient Writing to Chris Hansen of Dateline

So far the consensus is Dr. Shlomo Raz at UCLA is the premier doctor in the world for mesh removals and approximately 100 – 150 women a month fly in from around the globe to have him peel eroding mesh off of their bladder and spinal column. His assistant, Elizabeth, says Dr. Raz finds a great deal of comfort from the thank you letters he receives from the grateful women.

Meanwhile hundreds of lawsuits against manufacturers have been filed and have been consolidated in the Southern District of West Virginia in multidistrict litigation to be heard sometime in 2012.

Synthetic mesh remains on the market.  #

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Sheri Ragan

Sheri Ragan is playing the waiting game – waiting for a hospital in Ormond Beach, Florida to decide when and if it will take Medicaid so she can have an infected biologic mesh implant removed by the doctor of her choice. At 42, Ragan still doesn’t know how she ended up with six years of pelvic pain following an inguinal hernia repair, first with synthetic mesh, then biologic mesh made from cadaver skin cells following a hysterectomy she apparently didn’t need.

Here is her story:

“In May of 2006, I had bilateral inguinal hernia repair open technique. The surgical mesh used is a material made by Ethicon, a Johnson & Johnson Company, it’s called Prolene Hernia System.  

“A month later I was back in to see my surgeon with the same pain I’d felt since the hernia patch was put in. He told me I didn’t have a recurrence and to get my ovaries checked out since the pain was coming from that area.

“I went to my gynecologist and after multiple tests she decided to do a full hysterectomy. The pathology report from my hysterectomy showed nothing. There was no evidence that I should have had a hysterectomy. My pain has not diminished since the hysterectomy.”

Ragan and her doctors thought either the Prolene hernia patch or the hysterectomy would have addressed her pain, but neither did. Her general surgeon in Saginaw, Michigan suggested she give it more time. When that didn’t work, he suggested a “little boost” in the form of some nerve blocks.

“I had two on the genital femoral nerve and one on the ilioinguinal nerve. The first one on the genital femoral nerve worked for almost 2 weeks.  The block on the ilioinguinal nerve did not work at all. I got my operative reports it said at the time he put the mesh in he took out my ilioinguinal nerve. I didn’t know that. Imagine getting a nerve block for a nerve I didn’t have, and he had ordered it!”

Sheri Ragan and grandson, Daniel

Pain Like Electric Shocks

Ragan was 36-years-old. She had a new grandson, grown children and pain that emanated from the incision site shooting down the leg which she describes “like electrical shocks”. Most days she was in a chair or in bed, unable to move or work. All of this for a hernia that she had never felt, but was diagnosed when she initially went to her doctor for some hip pain.

“They said the pain was nerve damage from what, they didn’t know. I brought it up to them about the mesh as the source of pain. I asked about the possibility of meshoma (chronic pain from mesh implant) and it balling up at the end.   He said it couldn’t be the mesh, it’s effective, it’s hard to believe you are the one person in my career…I’ve never had this happen. When I brought up terms I had learned, that’s when he knew I knew something and he rushed me out of his office.”

Ragan says she kept digging deeper to find out more and her conversations with others told her she was not alone. Another woman in Saginaw had gone to the same doctor for a hernia repair, she also had complications following the synthetic mesh implant and is currently hospitalized with a bowel obstruction surgery. Her nephew had synthetic mesh implanted to treat a hernia and is still suffering complications. Yet another doctor, this one in Ann Arbor said he didn’t think it was the mesh. Sometimes you get chronic pain afterward, she was told. Live with it.

Mesh Complications?

Ragan says she became more convinced that the pain she was experiencing was the same as others she read about who had the same experience following a mesh implant – the same story, the same pain. Once again, she returned to her gynecologist who did the hysterectomy and she called in another doctor to look for symptoms of any mesh complication in the groin area.

“He ended up assisting and taking out a dime piece of mesh that was poking through my peritoneal. When I went back for my six week checkup I asked about removing it all. He said ‘I know how to remove the mesh, am I going to do it? No, because I’m not going to fix someone else’s mistake.’ He wouldn’t tell me what it meant. I was ready to cry and give up,” she says.

Once again not deterred, Ragan had a plan. She would raise the funds she needed to see Dr. Bruce Ramshaw, recommended by hernia mesh injured patient advocate, Bruce Rosenberg. Dr. Ramshaw was in Missouri and charged about $12,000 to remove hernia mesh. Selling her household goods she failed to raise enough for the surgery. So she turned to Plan B – purchasing a vehicle, Ragan went to see a doctor in Dearborn, Michigan who had removed a friend’s synthetic hernia mesh. She drove from Saginaw to Dearborn, had the mesh removed as promised at the Oakwood Healthcare System. But the surgeon there replaced the synthetic mesh with a biologic material called Alloderm, made from harvested cadaver cells.

Sheri Ragan, Walk for Life

Walk for Life

Ragan says she was on Cloud Nine for the first time in a long time. The doctor had removed her mesh and took pictures of it. You could clearly see it had balled up and was hard as a rock, she says. For the first time in a long time she was pain-free. Back in Saginaw, she participated in a Relay for Life cancer fundraising walk and enjoyed time with her grandson, Daniel, who she calls the pride and joy in her life.

Then the pain began again.

“It started going downhill and the pain came back slowly. I went back to the Dearborn doctor and he said well, since this one didn’t work out I can’t help you anymore. The day after that, I ended up in the hospital emergency room for a suicide attempt. I took too much medication. I just wanted to go to sleep. I was so devastated. I thought I can’t do this again. There was no indication what was causing the pain and he said I should start back on pain management again.. All I heard was blah, blah, blah, ‘the rest of your life.’ ”

Sick and Alone

By this time, Ragan was alone. Her husband had divorced her. One of her three children was not speaking to her, another was angry because she couldn’t attend her high school graduation. With nothing holding her back, she moved to Holiday, Florida to live with her sister and to move closer to Dr. Ramshaw, who had now moved to Halifax Medical Center in Ormond Beach.

“I was going to get him no matter what it took,” she says.  Dr. Ramshaw has Ragan’s medical records and the hospital is now waiting to see if it will take Medicaid, the insurance she has with her supplemental SSI Disability, the disability she’s suffered since her initial prolene mesh repair.

“He tells me it isn’t 100 percent guaranteed and I understand that it will be my last resort. I’m in pain every day. If I walk too much and overdo it, there is a shooting pain inside of my legs, so I try to avoid that. I can’t sit up straight for a long period of time. I live close to a fishing hole and go there and sit back and relax. Other times I sit on the couch and play online or watch TV. There is not much I can do now.”

“I’m very mad, I don’t know who to trust anymore. There is nothing else that’s going to be in my body anymore, that’s for sure. What I don’t understanding is (her first mesh) it’s the same exact mesh used for vaginal prolapse. Why are the FDA warnings not for hernia patients like us? It’s hurting as many hernia patients as women for vaginal prolapse, there is a wider range of people because it effects both men and women.”

*Editors Note* Ms. Ragan had the AlloDerm biologic mesh put in after the Ethicon synthetic mesh was removed.  Developed by LifeCell in 1994 to be used in burn care and later in plastic surgery, the human tissue implant comes from donated cadaver skin cells that are harvested and processed to form a skin graft.  Biologic mesh was thought to be a safer alternative to those made from polypropylene, a petroleum-based product used in most synthetic mesh.

Problems arose in 2005 when LifeCell Corporation of Branchburg, New Jersey, had a lapse in internal quality processes after questions were raised about the donor documentation received from one tissue recovery organization.

That’s when the company issued a quiet, voluntary recall of its biologic mesh. The FDA notification is here.
Ragan’s Dallas attorney, Bill Curtis, says he has 40 to 50 of these cases and the complications arose when LifeCell’s sales reps promoted the off-label use of AlloDerm for internal use and hernia repair between the years 2002 and 2009.

“It sounds a little better than an artificial graft but if you’re going to stretch the mesh again to repair an overly stretch material, they reherniate and in the worst conditions cause infection,” he tells MDND.  Additional surgeries often follow an AlloDerm implant along with abdominal pain, disfigurement, a recurrence of the hernia, abscess, infections which can be life-threatening, swelling, and discomfort.

AlloDerm is no longer recommended for hernia repair.  #

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