Gasp!: Surgeon/Designer Calls His Own Pelvic Mesh Device Garbage

“I would not want my wife to undergo this procedure”: pelvic mesh inventor

Joanne McCarthy

4 Jul 2017, 12:04 p.m  FiDA highlight

LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.

Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.

The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.

Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".

Mr Bannon told the court the comments' message was "those of us who were in the know".

"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.

The landmark case, which has attracted international media attention, is expected to take six months.

Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.

"Their enjoyment of life has been seriously compromised,” he said.

"Their lives have been dramatically altered for the worse.”

Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.

The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.

The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.

They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.

Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.

They were more likely "mid-career doctors" who saw their practices as businesses.

The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.

The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".

Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.

He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.

The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.

One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.

Ms Manion was visibly upset through some of the evidence.

The hearing continues.

http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

27% Device Failure Rate: Johnson & Johnson DePuy Pinnacle

Study finds 27% overall all-cause Pinnacle metal-on-metal THR failure rate at 10 years

June 1, 2017

VIENNA — Patients treated at a single center with one brand of metal-on-metal total hip replacement had a statistically significantly greater risk of implant failure if they had bilateral surgery or were operated on in 2006 or later, according to the 10-year results Gulraj S. Matharu, BSc (Hons), MBChB, MRCS, of Oxford, United Kingdom, presented 31 May, at the 18th EFORT Annual Congress in Vienna.

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The 569 patients studied retrospectively had standard demographics, he said. They underwent THR with the Pinnacle prosthesis (DePuy Synthes) with a 36-mm cobalt chrome head and an uncemented Corail stem (DePuy Synthes).

Gulraj S. Matharu

“This large cohort study of Pinnacle metal-on-metal (MoM) [total hip replacements] THRs has confirmed a high failure rate at 10 years with this device, but it is especially seen if the Pinnacle was put in from 2006 onwards and in bilateral MoM hip patients. This supports the recent and serious concerns about potential manufacturing differences in more recent years,” Matharu said.

Some of those problems led to edge loading and/or high friction, he noted.

In the first 4 years of the implantations, “there was no significant difference in failure rate between the early and late implantations,” Matharu said.

“Seventeen percent of our cohort were failures, the majority of these being for [adverse reaction to metal debris] ARMD, which is unsurprising,” he said, noting 72 patients (12.7%) had a failed THR due to ARMD. – by Susan Rapp

Reference:

Matharu GS, et al. Paper #710. Presented at: 18th EFORT Annual Congress: 31 May - 2 June 2017, Vienna.

Disclosure: Matharu reports no relevant financial disclosures.

http://www.healio.com/orthopedics/hip/news/online/%7B77410a2b-02e1-4254-ae8e-86189e316c36%7D/study-finds-27-overall-all-cause-pinnacle-metal-on-metal-thr-failure-rate-at-10-years

Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes

Bayer’s Essure Contraceptive Implant, Now With a Warning

By RONI CARYN RABIN            NOVEMBER 21, 201

Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.

The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.

Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.

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Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.

EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES

“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”

Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.

Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.

F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.

The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.

Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.

“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.

The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.

The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.

Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.

“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.

“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.

Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.

The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”

Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.

The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.

Many doctors who insert the implant do not know how to remove it.

By contrast, drug trials are required to have a comparison group of participants who are given a placebo.

Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.

This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.

The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.

Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.

http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F

27 Fatalities of Implanted Device: C.R. Bard CEO Sells $7M Shares

Medical Device to Prevent Blood Clots Associated With 27 Fatalities (Video link 4:37)

by TIM SANDLER, STACEY NAGGIAR and STEPHANIE GOSK

September 3, 2015

Serious questions are being raised about a medical device implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws.

At least 27 deaths have been associated with the Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade, an NBC News investigation has found.

Government data shows approximately 300 other non-fatal problems have also been reported with the Recovery, which is one of thousands of medical products sold by C.R. Bard.

Dodi Froehlich, 45, got hers after severe injuries in a 2004 car accident put her at high risk for clots. The filter was supposed to stop them from reaching her heart or lungs; instead, it nearly killed her.

Four months after it was implanted, she developed a severe headache and passed out.

"In that two seconds of being in the ambulance, I started flat-lining," Froehlich told NBC News.

Testing revealed a piece of the filter had broken off and pierced her heart, and she had to have emergency open-heart surgery.

"My family was notified," she said. "The priest was brought in."

Surgeons were able to remove the broken piece during emergency open-heart surgery and save Froelich's life, but not all Recovery recipients have been so lucky.

Gloria Adams, then 55, needed a filter after a brain aneurysm in 2004. Her son Kevin Keech says "everything was fine" when she was discharged from the hospital — but a week later, she was dead.

An autopsy showed that instead of the filter stopping a clot, a clot pushed the entire device into her heart, puncturing it.

"I didn't get many answers at that point," her son said.

After the problems with the Recovery began, Bard hired public-relations giant Hill and Knowlton. The firm circulated a crisis management plan to Bard management, warning that "unfavorable press" could damage stock prices and ruin reputations. The company also retained an outside doctor to conduct a confidential study, which was obtained by NBC News.

The consultant found the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.

"Further investigation...is urgently warranted," the doctor wrote.

But even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.

Each year, about a quarter of a million blood clot filters are implanted in patients who can't tolerate blood thinners, most without incident. Eleven companies sell them in the U.S., but Bard's Recovery filter stood out early as a risky device.

Bard officials declined NBC News' requests for interviews but in a statement said all its filters have been "appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate "significant benefits to patients."

Getting FDA clearance took more than one attempt. After the agency rejected one application for the Recovery, Bard, in 2002, recruited Kay Fuller, a veteran regulatory specialist, to help try again.

In an exclusive interview with NBC News, Fuller raised questions about how Bard handled that application.

She says the company did not give her important safety performance test results and that a small clinical trial raised red flags.

"I was pretty concerned there were going to be problems with this product," she said.

However, when she voiced those concerns, she said, the message she got was that she would be removed from the team if she continued to pursue the matter.

"I was shocked," she said.

Read Part Two of NBC News' Investigation tomorrow: Did C.R. Bard forge Kay Fuller's signature on a key document submitted to the FDA?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

@NBCNightlyNews

@StephGosk

http://www.dakotafinancialnews.com/insider-selling-timothy-m-ring-sells-40000-shares-of-c-r-bard-stock-bcr/405340/

Insider Selling: Timothy M. Ring Sells 40,000 Shares of C R Bard Stock (BCR)

September 3rd, 2015 - 

C R Bard (NYSE:BCR) CEO Timothy M. Ring sold 40,000 shares of the stock in a transaction that occurred on Monday, August 31st. The stock was sold at an average price of $195.17, for a total value of $7,806,800.00. Following the transaction, the chief executive officer now owns 119,694 shares in the company, valued at approximately $23,360,677.98. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.

Several equities research analysts recently commented on BCR shares. Zacks raised C R Bard from a “hold” rating to a “buy” rating and set a $194.00 target price for the company in a research note on Wednesday, June 24th. Goldman Sachs raised C R Bard from a “neutral” rating to a “buy” rating and lifted their price objective for the company from $193.00 to $220.00 in a research note on Thursday, August 27th. TheStreet cut C R Bard from a “strong-buy” rating to a “hold” rating in a report on Monday, August 24th. Brean Capital reiterated a “hold” rating on shares of C R Bard in a research note on Thursday, July 23rd. Finally, KeyBanc began coverage on shares of C R Bard in a research note on Thursday, August 27th. They issued a “sector weight” rating for the company. Seven investment analysts have rated the stock with a hold rating and four have issued a buy rating to the company. C R Bard presently has a consensus rating of “Hold” and a consensus target price of $193.38.

Shares of C R Bard (NYSE:BCR) traded up 2.30% during mid-day trading on Wednesday, hitting $191.86. The company had a trading volume of 512,486 shares. The stock’s 50-day moving average is $191.45 and its 200-day moving average is $176.17. The stock has a market cap of $14.24 billion and a price-to-earnings ratio of 42.34. C R Bard has a 52-week low of $141.49 and a 52-week high of $202.47.

C R Bard (NYSE:BCR) last announced its earnings results on Thursday, July 23rd. The company reported $2.27 earnings per share (EPS) for the quarter, topping the Zacks’ consensus estimate of $2.18 by $0.09. During the same period in the previous year, the firm posted $2.06 earnings per share. The business had revenue of $859.80 million for the quarter, compared to analysts’ expectations of $836.18 million. The firm’s revenue was up 4.0% compared to the same quarter last year. Equities analysts forecast that C R Bard will post $9.08 earnings per share for the current year.

FDA Regulators and Gynecologists Duped by Medical Device Manufacturer?: Essure Patient Harm Mounts

Essure:Failure to communicate risks

Posted by Zuzanna Fimińska [1] on May 28, 2014

The permanent method of contraception for women continues to cause controversy, but evidence seems lost amidst the heated debate. Personal stories dominate the discourse, and while the medical community appears divided, the media demand a response from Bayer, which hides behind a generic statement.

Since 4^th November 2002, Essure’s approval date, through 25^th October 2013, the FDA received 943 reports of adverse events related to the product. The most frequently reported adverse events were pain (606), hemorrhage (140), migration of the device or device component (116), patient device incompatibility (113),and device breakage (37), among others¹. Only three of those adverse events were featured in the information booklet that accompanied the procedure, and, according to the women we spoke with, doctors who performed the procedure weren’t informed about possible side effects either.

The original pamphlet contained incomplete and misleading information

“I was absolutely not well-informed about the risk-benefit profile before undergoing the procedure,” said Angie Firmalino, who founded the Facebook group called Essure Problems [2] in 2011, two years after undergoing the procedure. The group now has 7,635 members, and adds 25-50 new members each week. “I received a pamphlet that looked like a vacation brochure. Perforations, migrations, and other side effects were not listed in it,” she said, adding that her OBGYN also failed to provide adequate information concerning possible side effects.

The pamphlet has since been updated. It now features possible side effects as well as a disclaimer that it is “not intended to be comprehensive as all women have individual needs and concerns.” Among the listed adverse reactions are unsatisfactory placement of the inserts in 8% of women in clinical trials (during a three month follow-up, incorrect placement was identified in an additional 4.5% of women). “Unsatisfactory placement” includes perforations that result from the device, and migrations of the coils. Other problems listed in the new booklet include breakage, nausea, sweating, pain, cramping, vaginal bleeding, heavy periods, and ectopic pregnancy, among others. 

There are three potential reasons the list of side effects was incomplete in the original booklet. One, Bayer hid trial results from the FDA. Two, the side effects are the result of long-term usage of the device, so they were not present in clinical trials, which are not designed to check long-term safety of a device. Or three, the trials conducted by the manufacturers were less than perfect. Firmalino believes the last possibility, calling Bayer’s trials “faulty and biased,” but she’s unwilling to speak about the details.

“Many women, including myself, have retained a law firm preparing to file suit against Bayer. The administrators of the Essure Problems page and I have been working closely behind the scenes with the firm, and we have collected much evidence and proof. It will all come out when the legal trials begin,” she said.

Essure is not an effective form of contraception

Despite a warning about possible ectopic pregnancies, according to the new information pamphlet, Essure is 99.83% effective although another form of contraception should be used for the first three months following implantation. According to Firmalino, the assurance that a woman would never again have to worry about pregnancy is very misleading.

“In our group, we have seen numerous pregnancies, some resulting in a miscarriage (on average, 55% of women pregnant with Essure will miscarry). We have seen some full term live births, some pre-term, and a handful of stillbirths. Bayer’s pregnancy rates are far from accurate,” Firmalino said.

Indeed, a new study coming out of Yale University seems to be supporting Firmalino’s observations. According to their estimate, 9.6% of women could become pregnant within 10 years of undergoing hysteroscopic sterilization, or Essure. This is nearly four times the estimated risk after a laparoscopic tubal ligation, the more traditional method.

The study, published in the journal Contraception, is the first to compare the effectiveness of the two main choices offered to women who seek a permanent form of birth control. According to the Chicago Tribune, about 345,000 American women undergo sterilization procedures each year, with Essure an increasingly popular choice because it does not require a surgical incision.

Crucially, if a woman does become pregnant after Essure, the risks to the mother and the fetus are unknown.

Doctors disagree on the safety of the procedure

The safety of the procedure has divided the medical community. Although some doctors extended their support to Essure Problems Facebook page, admitting that there is a problem with the device, others have no doubt the procedure is the right choice for women. For example, Steve Parsons, an OBGYN and the main provider of the Essure procedure in the Netherlands, makes a bold statement that he "believes in Essure because he believes in women". He compares Essure to other metallic devices implanted in the body, e.g. clips and coils used to open blood vessels around the heart when patients have suffered a heart attack. Furthermore, he suggests that there are two logical explanations regarding pelvic pain and other symptoms that occur after Essure. One, he admits that the symptoms might be due to the device. Two, he suggests that the might be caused by other conditions such as PMS or perimenopause. In his conclusion, he addressed the Essure Problems community saying that “it is sad that this group, some of whom may have valid gynaecological problems, are scaring a lot of women out of a safe procedure, forcing them into a riskier option.” He then requested to be removed from the group.

We, as doctors, have accepted the manufacturer’s word for the safety of the device without anything to confirm it".

In a rebuttal of Parson’s statement, doctor Julio Novoa writes that the comparison between Essure and devices used in heart surgery is invalid because those devices, unlike Essure, aren’t designed to cause a chronic inflammatory response. He also asserts that there are no peer-reviewed, double-blind studies addressing the safety or the incidence of complications regarding Essure compared to the general population regarding chronic pelvic pain, abnormal vaginal bleeding, etc. “We, as doctors, have accepted the manufacturer’s word for the safety of the device without anything to confirm it,” he writes.

Faulty device, or failure to communicate risks?

Whether or not Essure is a faulty device remains unclear. The FDA was unwilling to speculate on whether or not the device might be pulled from the market, but they don’t seem to be concerned about the safety of the product. “The FDA has not found a causal connection between the use of Essure and certain adverse events reports,” said Jennifer Rodriquez, a spokesperson for the FDA in charge of the Essure case. Nevertheless, she also stressed that the Agency continues to take reports of problems with Essure very seriously and will continue to review them carefully. “We will continue to monitor the safety of Essure to make certain that it does not pose an increased risk to public health and safety and that its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks,” the statement read.

Firmalino was disappointed with the FDA’s stance, and said that she’d expected the Agency to “protect the population, as is their job". She added: “However, we are finding that they, too, are regurgitating the same answers, relying on faulty clinical trials. There seems to be a lot of conflict of interest that lies within the FDA and pharmaceutical companies and device manufacturers”.

Bayer failed to respond to our request for comment about the long-term safety of the device.

The heated debate around Essure continues and is likely to only be settled in court. Sympathetic plaintiffs, big pharma manufacturer as defendant, and a device with a questionable safety profile will certainly attract broad media attention. But perhaps concerns over product safety are not the only problem here. Bayer is obviously in need of some damage control if they want to retain any public trust that is already fragile. Hopefully this high profile class action law suit will not be necessary to elicit some response from the manufacturer.

1. I was referred to this data by the FDA spokesperson, Jennifer Rodriguez in an email exchange. According to other sources, the numer has skyrocketed to 2,049 as of March 2014.  

Links:
[1] http://social.eyeforpharma.com/users/zuzanna-fimi%C5%84ska
[2] https://www.facebook.com/pages/Essure-problems/178631888835781

BBC Radio exposes the lack of regulation of implanted medical devices!

Face the Facts!: Tried and Tested?

New drugs undergo strict testing. New medical devices often don't have to. But with thousands of women damaged by vaginal surgery, surgeons and patients are calling for tougher safety rules. It's the latest in a series of controversies around new medical devices stretching back years - including metal-on-metal artificial hip joints and PIP breast implants.

Concerned surgeons say a compulsory register for all devices is long overdue, so we can track success and failure. But might insisting on too rigorous a testing regime have the unintended consequence of stifling medical innovation and making it too expensive for all but the biggest companies?

Presenter: John Waite Producer: Paul Waters Editor: Andrew Smith.

• Broadcast onBBC Radio 4, 12:30PM Wed, 22 Jan 2014
• Available until12:00AM Thu, 1 Jan 2099
• First broadcastBBC Radio 4, 12:30PM Wed, 22 Jan 2014
  http://www.bbc.co.uk/iplayer/episode/b03q9dc8/Face_the_Facts_Tried_and_Tested/

Shocking: Transvaginal surgical mesh scandal!

Revealed: Shocking figures reveal that hundreds of women have been affected by mesh implant scandal

By Marion Scott  22 Dec 2013 07:31

POLITICIANS joined victims and experts yesterday to demand the immediate suspension of mesh implants as figures reveal hundreds of women suffered horrific side effects – not just six as ministers claimed.

The call comes as lawyers prepare to lodge the biggest medical claim in Scottish legal history, with 400 victims set to sue the implant manufacturers and the NHS.

Pressure was mounting on Health Secretary Alex Neil over the scandal – first exposed by the Sunday Mail in March – after his officials 
were accused of understating the number of women who endured terrible pain caused by the transvaginal mesh.

Yesterday, Labour’s health spokesman Neil Findlay said: “The Scottish Government do not appear to have a clue what is going on.

“Heath officials told us just six women had been reported as suffering adverse effects, therefore mesh was safe to use to treat stress incontinence and pelvic prolapse.

“But figures from individual health boards across Scotland confirm almost 300 victims are showing such severe complications that 
surgeons are trying to remove the mesh.

“Two health boards are still to release figures so the final toll is likely to be many more.

“We must suspend mesh procedures until we know the true picture.

“The burden the NHS now face legally, as well as trying to treat those with life changing complications, is catastrophic.”

Government figures state just 2915 women have been given implants since 2007 but figures from health boards suggest at least 8077 women have had the surgery.

While the procedure was successful in many cases, some women were left with a legacy of crippling pain and have been forced to endure years of worry and further surgery.

Medical experts warn it can take years for the complications to emerge.

Lawyer Cameron Fyfe intends to use laws designed to allow asbestos victims to claim compensation without showing immediate physical damage.

He said: “We are so confident, we are proceeding on a no-win, no-fee basis so victims need not worry about the difficulties of trying to claim legal aid.

“The claim against manufacturers will state mesh was deficient and not fit for purpose.

“Claims against the NHS will be that they did not properly inform patients of all the risks or offer alternative treatment in many cases.

“Many were unaware mesh implants are supposed to be permanent. Others fear they have a timebomb inside them.”

Victims have had to undergo up to a dozen operations as doctors battle to remove mesh designed to merge with a patient’s tissue.

Complications range from pain during intercourse to bowel and bladder perforations, crippling nerve damage, lifelong pain and mobility problems.

Manufacturers claimed mesh was soft but evidence shows that it can harden inside the body and damage tissue and organs.

In one test sample of a mesh product, almost one in four showed bladder perforations.

In another test of almost 700 women, a third developed complications.

One of the world’s top specialists in the field wrote to Neil, imploring him to stop the use of the controversial products.

US professor Tom Margolis said: “The use of transvaginal polypropylene mesh for the treatment of prolapse and incontinence must stop immediately.

“There are a host of traditional surgical procedures available which have a zero mesh complication rate.”

The Health Secretary claims banning mesh ops may leave the Scottish Government open to legal action from manufacturers.

But Lothians MSP Findlay said: “Despite being alerted to the crisis nine months ago, Alex Neil has done nothing more than pay victims lip service while the numbers and seriousness of the situation have been obscured.

“As it is quite clear the government have no idea how many women are affected, they must issue a suspension notice on use of transvaginal mesh products until a public inquiry can establish the facts.

“Victims asked Neil to create a Scottish register and legally compel doctors to report adverse reactions to these products so we can get a true picture of the depth of this scandal.

“But although UK medical watchdog the MHRA have said Scotland has the power to do both things, he has refused to do so.

“When victims asked him to suspend the use of mesh products until an inquiry takes place, Alex Neil told them he feared legal action by manufacturers.

“Is he really prepared to put the quality of women’s lives at risk for the sake of offending manufacturers? Surely not.”

Last month, we revealed NHS officials knew four years ago that patients were not being fully informed of all the risks involved with mesh implant surgery. When Neil met victims in May, he promised that GPs would be contacted to inform them of all the possible side effects and every patient would be told which implant they have received.

But yesterday campaigner Elaine Holmes, 49, said: “We’re still waiting.

“GPs are still unaware of all the side effects to look out for and women are still not being told the truth about a device that can change their lives forever.

“If people were told the truth, nobody would consent to having these implants.”

The Scottish Government have denied that they have deliberately played down the number of women affected by the mesh scandal.

A spokesman said: “It is not possible to compare numbers without examining what questions health boards were asked or which procedures they were reporting on.”

Leslie McGlinchey was just 29 when she had the operation which doctors promised would change her life.

Yesterday, the mum-of-two said: “It did change my life. Because of what they did to me, I’m in a wheelchair until I die.”

She said: “When I think about it now, I could weep. I’d had a couple of ‘accidents’ when I was running about daft with the kids. When I told my doctor, she said, ‘Why not get treatment?’

“The specialist said it was a routine operation, and I’d be back on my feet in a couple of days. It 
all sounded so simple.

“I didn’t realise they were going to implant a permanent mesh tape device which would cause so much pain and nerve damage, I’d end up crippled and in a wheelchair.

“If I’d known any one of the things I now know about mesh, I would never have agreed to surgery.

“When I woke up after the op, I was in agony but the nurses told me not to worry as some pain was normal.

“I was discharged from hospital the next day still in agony and I’ve now lost count of how many times I’ve had to go back.

“Eventually, the specialists finally agreed that the pain and numbness I was feeling in my back and lower body was down to the implant.

“In October, they tried to remove as much as they could but I’m convinced there’s still mesh inside me because of the pain.

“Now I can’t stand for more than a couple of minutes without falling on my face.

“My body feels as if it isn’t my own any longer. I can’t control it. I don’t feel like a woman any more – I’m broken and in constant pain.

“The doctors have told me all they can do now is try to manage my pain, which means I’ve got to spend the rest of my life taking the most powerful drugs my body can handle.

“I was about to start a new life and become a hairdresser. Now I’ll be on disability benefits for the rest of my life.”

The hardest thing for Leslie, of Drumchapel, Glasgow, is how to tell her daughters Morgan, 10, and Elle, eight, that she won’t ever be able to run with them in the park or take them out shopping.

She said: “They’re really frightened because they’ve seen me screaming in pain and trying to stand and falling over. I can’t find the words to tell them I’ll never be the mummy I used to be.

“Last time I tried to stand and fell over, the girls lay down beside me and stroked my hair and told me they had fallen down too.

“It’s gut-churning to see them trying to cope with what has happened.

“I can’t even dress myself. I rely on them, my parents or my friends to help me get washed and dressed in the mornings.

“I can’t do all the things I used to do for my girls, take them to the park or just a trip to the shops. I feel like someone has stolen my life and I’ve been left in this broken shell – and all because I believed what the doctors told me.

“I feel very angry. There are so many things I wasn’t told about this operation. I feel I have been betrayed and lied to.

“I yearned to be a mum and have my own family. Now my family are having to help me look after my girls. If it wasn’t for them all and my best friend, I don’t know how I would get through each day.”

Leslie never dreamed there were other women suffering the same life-changing complications until she read the Sunday Mail reports revealing the full extent of the mesh scandal.

She said: “When I read the paper, there were tears running down my face. These stories could have been written about me.

“The helplessness, the despair, the feeling of hopelessness and the lies we’ve all been told.

“Reading the Sunday Mail saved my life. I was in such despair, I’d been planning to end it all.

“But reading about the others has given me a new strength and resolve to get justice for what’s been done to us all.

“My friends and family have been able to sympathise but nobody really knows how this feels until it happens to them.

“If my story helps change anything and stops this happening to any other women, I will feel vindicated.

“Experts have known for years the damage these implants have been causing but they couldn’t even be bothered filling out a few forms to warn others about what’s been happening.

“Those who keep silent and do nothing now shouldn’t be allowed to be doctors because they know full well the harm this stuff is doing.

“It’s down to politicians to stop other women’s lives being destroyed. I dare them to look into my eyes and tell me this is all in my head.

“I want them to imagine having their whole life ahead of them and it all being taken away in an instant. Only then will they know how I really feel.

“Those who sit on their hands and do nothing to protect us are not fit to be in public office.

“They have to get this stuff banned before even more women are butchered.”

Mum-of-three Karen Neil was about to kill herself in despair after doctors told her she was imagining the horrific 
complications of her mesh op.

Only the fear that it would be her young daughter who found her body stopped her.

She kept a diary of her day-to-day battle with pain and the Sunday Mail initially told her story anonymously. Now she has the courage to go public after realising she is not alone.

She said: “From the moment that mesh implant was placed in my body two years ago, there was an immediate reaction and I awoke screaming in pain.

“But specialists told me the pain was just in my head – there was no way it was related to the mesh implant.

“They had me believing I was going crazy when all along they knew mesh was to blame. When I read the Sunday Mail, I couldn’t believe my eyes.

“I wasn’t alone after all but ours is the saddest sisterhood in the world.

“Our lives and health have been broken but together our determination to stop this happening to other women is keeping us strong.”

Teaching assistant Linda McLaughlin, 57, from Greenock, said: “I’ve had 10 operations to try to repair mesh damage and I’m waiting to go into hospital again.

“I get angry when I think about the legions of doctors who have seen for years the damage these mesh implants cause but they’ve all kept their heads down and their mouths shut instead of speaking out for their patients.

“Until recently, only two doctors in Scotland had reported an adverse complication and that is a shameful dereliction of duty.”