Preview Newsletter
Ethicon Media Monitoring 3/14/2017
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House Judiciary Committee targets lawyer ads, mass torts marketing
Mar 13, 2017 | Reuters
By Alison Frankel
Bob Goodlatte, the Virginia Republican who chairs the U.S. House Judiciary Committee, isn’t yet done kicking plaintiffs’ lawyers in the gut. -
J&J Facing Surging Litigation Costs
Mar 13, 2017 | Mesh Medical Device Newsdesk
Johnson & Johnson (J&J) is facing at least 17 different lawsuits in the coming year. -
Transvaginal mesh devices have left many women with permanent injuries
Mar 14, 2017 | Newcastle Herald
ONE of Australia’s leading obstetricians and gynaecologists landed a damning indictment on his own profession and the health system in 2013 in a paper titled “The Transvaginal Mesh Decade”. -
Pelvic mesh devices hit by allegations of research fraud, experimental surgery on thousands of women
Mar 14, 2017 | The Sydney Morning Herald
By Joanne McCarthy
Pelvic devices developed in Australia from the 1980s and 1990s are at the centre of a global medical scandal that includes regulatory failure, and allegations of research fraud and experimental surgery on women in multiple countries. -
Newcastle doctor and Queensland colleague sounded alarm on mesh in 2003
Mar 14, 2017 | Newcastle Herald
By Joanne McCarthy
IN 2003 two doctors – Newcastle’s “grand old man” of obstetrics and gynaecology, Dr Alan Hewson, and his Brisbane colleague, Dr Chris Maher – wrote a paper sounding the alarm about a pelvic mesh procedure after treating women with serious complications following mesh surgery. -
Transvaginal mesh devices under the spotlight
Mar 14, 2017 | Bendigo Advertiser
By Joanne McCarthy
“WeE were guinea pigs, we just didn’t know until it was too late,” said Caz Chisholm, who can barely contain her rage against doctors, regulators, the manufacturers of transvaginal mesh devices and a health system that has catastrophically failed women.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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House Judiciary Committee targets lawyer ads, mass torts marketing
Mar 13, 2017 | Reuters
By Alison Frankel
Bob Goodlatte, the Virginia Republican who chairs the U.S. House Judiciary Committee, isn’t yet done kicking plaintiffs’ lawyers in the gut.
In the midst of a week in which the House of Representatives passed a series of bills to curtail class actions and mass torts litigation, Rep. Goodlatte issued a press release signaling his next target: lawyer advertising and marketing for personal injury clients. The Judiciary chairman sent letters to the American Bar Association and the bar associations of all 50 states and the District of Columbia, urging them to require all legal advertisements to include a disclaimer advising patients to consult a doctor before discontinuing their use of supposedly dangerous medication. Goodlatte cited a resolution adopted last June by the American Medical Association, which said patient care is jeopardized by ads from personal injury lawyers prowling for clients. “The legal profession, which prides itself on the ability to self-regulate, should consider immediately adopting common sense reforms,” the Goodlatte letter said.
Advertising by personal injury lawyers, as you probably know, is a particular bugaboo for the Chamber of Commerce. The Chamber’s Institute for Legal Reform issued a 2015 report claiming that trial lawyers were projected to spend nearly a billion dollars that year on legal ads, nearly twice what they spent in 2008. Tort reform groups have even started their own ad campaigns spoofing over-the-top spots by plaintiffs’ lawyers.
Alas for defendants, the U.S. Supreme Court said in 1977’s Bates v. State Bar of Arizona that the First Amendment allows lawyers to advertise for personal injury clients. Without lawyer ads, Justice Harry Blackmun wrote in the majority opinion, “the not-quite-poor and the unknowledgeable” might not be informed of their legal rights. “Although advertising might increase the use of the judicial machinery, we cannot accept the notion that it is always better for a person to suffer a wrong silently than to redress it by legal action,” Blackmun wrote. The Bates opinion is a giant obstacle for any legislation to restrict lawyer ads, which is presumably why Goodlatte is prodding for self-policing from the ABA and state bar associations.
Goodlatte also sent a potentially more consequential letter to a legal advertising firm called the Relion Group. Based on its website and the website of its parent company, Lead Generation Technologies, Relion seems to be a mass torts client generator. It runs advertisements about supposedly dangerous drugs and medical devices, advising prospective clients to call toll-free telephone numbers. Prospects are presumably screened by call center telemarketers and referred to plaintiffs’ firms in Relion’s legal network. (“You pay only for the qualified leads you receive that are pre-screened to meet your lead criteria,” the Relion site promises.)
I’ve spent a lot of time learning about the far-flung – and unregulated – industry of helping plaintiffs' lawyers find and sign up mass torts clients. My reporting focused on the vast litigation over pelvic mesh, in which the defendant American Medical Systems has alleged some extremely shady behavior by a mass torts lead generator called Law Firm Headquarters. According to AMS, Law Firm HQ improperly solicited clients to file mesh claims and worked with a medical funding outfit to lure mesh plaintiffs into unnecessary surgery in order to obtain bigger settlements. Law Firm HQ’s sister company, Excelium, filed for bankruptcy last August and is under investigation by a federal bankruptcy trustee. It has denied all of AMS’s accusations of misconduct.
To be absolutely clear: There is nothing in Rep. Goodlatte’s three-page letter to Relion to suggest Relion is engaged in illegal or unethical practices. Nor is there any indication of why the congressman chose to write to this particular company, which is certainly not the only mass torts lead generator in the business. Goodlatte’s letter, in fact, includes references to anti-Xarelto ads by the Sentinel Group, another mass torts marketer, and by the since-dissolved law firm Pulaski & Middleman, which specialized in signing up mass torts clients for referral to other law firms that actually litigate cases.
But Goodlatte demanded responses from Relion on some very pointed questions, not just about legal advertising but about its marketing tactics as well. Congress wants to know which plaintiffs firms Relion works with, how it acquires names of potential direct marketing leads, what information it collects from prospective clients, where its call centers are located and how it vets telemarketers. Goodlatte also asked Relion to provide copies of all of the company’s active contracts with plaintiffs' lawyers. The letter, addressed to Relion executive Brendon Condon, orders the company to respond by March 21.
Mass torts marketing doesn’t get much attention from the outside world, even though it’s a crucial cog of the machinery of big personal injury litigation. If you look at the roster of sponsors for just about every conference of trial lawyers, you’ll find legal marketing shops that promise to help lawyers find clients. The ABA model rules allow lawyers leeway to use these services, though at least some state bars prohibit lawyers from paying referral fees to for-profit lead generators.
Goodlatte’s letter to Relion could be the beginning of significant federal scrutiny of the way plaintiffs' lawyers obtain clients. That’s not going to be an inquiry the plaintiffs' bar will welcome.
I emailed Relion and Lead Generation Technologies for comment on the House Judiciary Committee’s letter but didn’t get a response.
http://www.reuters.com/article/us-otc-masstorts-idUSKBN16K2JM
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J&J Facing Surging Litigation Costs
Mar 13, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 13, 2017 ~ Johnson & Johnson (J&J) is facing at least 17 different lawsuits in the coming year.
And 2017 promises to be even worse for litigation and the cost of legal services with an increasing number of people suing the healthcare giant.
J&J lost six of seven verdicts in 2016.
The number of lawsuits jumped to 104,700, according to a recent securities report filed February 27, 2017. That’s up from 28,300 in 2016. Litigation expenses increased to $817 million.
There are five major areas of litigation.
Risperdal – Men claim they grew breasts after taking the antipsychotic medicine Risperdal. So far, 18,500 lawsuits have been filed. J&J lost a trial last year in Philadelphia where the jury awarded $70 million to a family of a boy who grew breasts beginning at age five. Another man was awarded $2.5 million by an Alabama jury in 2015. He developed size 46DD breasts.
The company failed to disclose evidence the drug could elevate levels of the hormone prolactin when prescribed to boys. Litigation shows Risperdal was marketed for uses not approved by the FDA, such as children with autism and attention deficit hyperactivity disorder.
The cases are on appeal.
“Contrary to the impression the plaintiff’s attorneys have attempted to create over the course of this litigation, Risperdal is an important FDA-approved medicine. We will continue to defend this litigation and will try cases where appropriate.”~ J&J SEC Report
Xarelto – There are 17,000 lawsuits pending over the drug Xarelto, a blood thinner that can lead to uncontrolled bleeding. The first MDL trial is set for April 24, 2017 in the Eastern District of Louisiana.
Pelvic Mesh – More than 54,800 women are suing over the company’s transvaginal meshes, the SEC filing reports. Outside of multidistrict litigation in Charleston, WV there are cases in state court in Bergen Co., New Jersey and the Court of Common Pleas in Philadelphia, as well as various state court actions.
Claims have also been filed in the United Kingdom, the Netherlands, Belgium, Italy and Venezuela. Class actions are underway in Israel, Australia and Canada.
An accrual is an estimate of legal defense costs needed.
“The company has established an accrual with respect to product liability litigation associated with Ethicon’s pelvic mesh products. Changes to this accrual may be required in the future as additional information becomes available.” ~J&J’s SEC Report.
DePuy ASR XL Acetabular System and Hip Resurfacing System is facing 2,000 plaintiffs as of January 1, 2017, and 9,400 with the Pinnacle Acetabular Cup System.
Talcum Powder – Talc and its link to ovarian cancer has more than 3,000 women filing lawsuits against J&J over its Baby Powder and Shower-to-Shower. Cases so far are filed in Missouri, New Jersey and California and plaintiff jury awards of $70 million and $55 million. J&J just won its first case in a St. Louis court recently.
The company announced it was restricting its Medical Devices segment to save pre-tax $800 million to $1 billion.
The company says its financial bottom line won’t be impacted by these legal proceedings but warns resolving lawsuits may have a “material adverse effect” on its earnings at some future date.
The SEC report says that medical device segment sales in 2016 were down 0.1% from 2015.
“The operational decline in General Surgery was due to lower sales of women’s health and urology products and pricing pressures partially offset by growth of sutures.”
In 2016 the Medical Devices segment income before tax as a percentage to sales was 22.2% versus 27.2% in 2015.
J&J EXPANSION, CONTRACTION
In recent months, J&J announced it would open a new office in Ghana in West Africa.
Without any specifics the focus will continue to, “lead the expansion of our product portfolio and continue to address many of the most prominent health issues impacting patients and health care providers here.” Specifics include mental health, diabetes, maternal, newborn and child health, HIV prevention and oncology.
Meanwhile the company is closing a surgical suture factory in Scotland also losing 400 jobs. The move is said to be part of the company’s global restructuring designed to streamline operations. The plant, located in Livingston, Scotland, produces 5-6% of J&J’s global output of surgical sutures.
The manufacturing operation may move to Texas, Brazil and Mexico.
On February 21, 2017, Judge Joseph Goodwin, who is overseeing the MDL in his Carleston, WV court, began creating the Wave 5 cases in his court. These are a list of 400 oldest cases in the Ethicon MDL. The pretrial activity should be wrapped up September of this year.
The Philadelphia Court of Common Pleas also has a waiting list of transvaginal mesh cases ready for trial. The next one is Engleman v. Gynecare to be heard April 20.
A group of patients and consumers injured by J&J products plans to attend this years Shareholders meeting to be held April 27, 2017 in New Brunswick, New Jersey, the company headquarters. ###
LEARN MORE:
J&J Pelvic Mesh Litigation- Bard and Gynecare
http://www.judiciary.state.nj.us/mass-tort/pelvicmesh/index.htmlGynecare Case List –
http://www.judiciary.state.nj.us/mass-tort/pelvicmesh/gynecare/gynecare-case.pdf
Updated March 11, 2017 J&J Cases Bergen, Co NJ, 181 pages, 9,009 lawsuits against Ethicon/J&J, 979 Bard casesList of cases against J&J/Ethicon filed in WV – 37,224 as of March 13, 2017
http://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2327
https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=140305384&genrc_par1=15&genrc_par2=&call_type=HSecurities and Exchange Commission, J&J, Feb. 27, 2017
http://www.investor.jnj.com/secfiling.cfm?filingID=200406-17-6&CIK=200406#FORM10-K20170101_HTM_S5107A649517004FE941649CE906A5FA8http://www.meshmedicaldevicenewsdesk.com/jj-facing-surging-litigation-costs/
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Transvaginal mesh devices have left many women with permanent injuries
Mar 14, 2017 | Newcastle Herald
ONE of Australia’s leading obstetricians and gynaecologists landed a damning indictment on his own profession and the health system in 2013 in a paper titled “The Transvaginal Mesh Decade”.
Associate Professor Chris Maher blamed regulators in America and Australia for clearing transvaginal mesh devices for use in women without original clinical evidence supporting safety and efficacy. The devices are used where women experience prolapse and incontinence problems after childbirth, and are implanted via the vagina.
The American Food and Drug Administration (FDA) made several serious mistakes in clearing a device, the IVS Tunneller, in 2001 for use in women with prolapse, Dr Maher said. The American system, which allows other devices to be “cleared” for use based on being “substantially the same” as earlier devices, supported a proliferation of prolapse mesh devices for the next 10 years or more. The results for many women have been devastating.
Products were “aggressively marketed” by manufacturers after the FDA clearance. More disturbing is that bodies traditionally associated with the training of doctors, such as their own medical colleges, were “largely silent” during the “transvaginal mesh decade”, Dr Maher said.
Instead the theory and surgical techniques of transvaginal mesh surgery was left to the manufacturers of the products and their paid key opinion leaders.
A Newcastle Herald investigation has uncovered disturbing gaps in Australia’s health regulatory systems, including an adverse event reporting process that relies on manufacturers to report complications and injuries to patients, and doctors who “do not have a strong awareness of Australia’s adverse event reporting systems”.
Australia’s Therapeutic Goods Administration (TGA) is not even able to give a percentage of women who have suffered adverse events after mesh surgery because, as it conceded in a report in 2013, there is “no way” to determine the total number of devices used to make comparisons to find complication rates.
The Australian Pelvic Mesh Support Group successfully lobbied Victorian Senator Derryn Hinch for a Senate inquiry into the scandal in Australia. It is taking submissions until May 31, with public hearings mid-year and a report expected in November. Serious questions need answers.
http://www.theherald.com.au/story/4527600/serious-questions-to-answer-on-pelvic-mesh/
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Pelvic mesh devices hit by allegations of research fraud, experimental surgery on thousands of women
Mar 14, 2017 | The Sydney Morning Herald
By Joanne McCarthy
Pelvic devices developed in Australia from the 1980s and 1990s are at the centre of a global medical scandal that includes regulatory failure, and allegations of research fraud and experimental surgery on women in multiple countries.
Devices invented, or co-developed, by an Australian and a Swedish doctor to treat urinary incontinence were bought, modified and led to regulatory clearances in America for companies including Johnson & Johnson from 2001, with little or no "good quality" evidence to support their use to treat prolapse complications in women after child birth.
Caz Chisholm, who set up the Australians Pelvic Mesh Support Group in November 2014, can barely contain her rage against doctors, regulators, the manufacturers of the mesh devices and a health system that she says has catastrophically failed women.
"We were guinea pigs, we didn't know until it was too late," she said.
Ms Chisholm said many women were not told the risks of transvaginal mesh surgery and so did not give informed consent.
"Current systems still don't allow the true extent of this disaster to be known. For so many women you're left feeling you're the only one experiencing these extreme consequences. It's only when women join the group they are able to say 'Oh my God, it's not just me. I'm not going crazy'," she said.
"If you've not consented to what is going to happen to you, and you wake with serious complications, you're not only dealing with the physical impacts of mesh but the emotional trauma of feeling violated.
"It is a violation of your body to have something in there that you didn't consent to."
She accuses Australia's Therapeutic Goods Administration (TGA) of not only failing women by approving transvaginal mesh devices without clinical evidence of safety and efficacy, but having an adverse events reporting system that completely failed to detect injuries to women, and of failing to respond quickly and appropriately when the extent of serious complications became apparent.
An investigation into the mesh devices
A Newcastle Herald investigation has found a mesh delivery device and procedure tested on 13 large dogs in Western Australia in 1987, which was developed and registered in America by a Tyco Healthcare subsidiary as the IVS Tunneller in 2001, became the first transvaginal mesh delivery system cleared in America to correct pelvic organ prolapse in women.
It became the "predicate case" relied on by many of the world's biggest drug companies to have transvaginal mesh kits "cleared" for sale in America over the following decade to treat prolapse, leading to clearances in Australia and countries around the world.
This was despite its development to treat urinary incontinence only, and where subsequent manufacturers were not required to produce original clinical studies to support prolapse use.
A second mesh device for incontinence, known as Tension-free Vaginal Tape or TVT, was developed after collaboration between Australian Dr Peter Petros and the late Swedish Dr Ulf Ulmsten, who also collaborated on the 1987 Western Australian dog tests that led Dr Petros to develop the IVS tunneller.
Dr Ulmsten later sold the rights of the TVT device to Johnson & Johnson.
In a paper in 2012, after the American Food and Drug Administration, FDA, announced complications after prolapse surgery using transvaginal mesh devices were "not rare", Dr Petros said his "early experimental studies" had been "wrongly" used as "an intellectual cornerstone to justify the use of mesh in prolapse surgery".
In the paper he distanced himself from the global mesh scandal, saying complications were related to "large sheet" mesh adopted by some companies, and not the small tapes advocated by him which preserved "vaginal elasticity".
He declined to comment when contacted by the Herald.
A Senate inquiry and court action
A Senate inquiry, launched after Victorian Senator Derryn Hinch told Federal Parliament that transvaginal mesh devices rivalled Thalidomide as one of Australia's worst health scandals, will hear from women across the country – including many from the Hunter and Central Coast – left with catastrophic injuries and taking doctors and companies to court for damages.
Court action includes one of the largest medical civil cases in Australia, starting in July and expected to run for six months, brought by 450 women against Johnson & Johnson.
Another 300 Australian women are registered for a second class action against American Medical Systems, which developed devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, and relied on the Australian-developed device for clearance.
More than 40 mesh devices were cleared for use by Australia's peak health regulator, the TGA, without clinical evidence of safety and efficacy, and despite strong warnings from three Australian specialists as early as 2003, including Newcastle gynaecologist Alan Hewson, that some surgical mesh procedures "cannot be recommended".
In a paper 10 years later one of the three gynaecologists, Queensland Professor Christopher Maher, criticised regulators, the medical profession, manufacturers and doctors who failed to disclose their ties with mesh manufacturers, for allowing "women we are trained to serve to be exposed to unknown risk".
He warned that global legal action could reach $20 billion and "be one of the largest ever class actions undertaken".
Mesh victim Stella Channing, who faces a future with a colostomy bag after doctors told her she could lose her vagina and rectum because of mesh complications, said she had lived in "unrelenting, disabling agony" since mesh surgery in 2011.
"I am just about to turn 59 and I cannot imagine living another 20 years like this," she said.
"Over the years I have thought, who does this to someone?"
A Newcastle Herald investigation has found:
· Alleged research fraud at a major Australian public hospital which confirmed no knowledge of, or approval for, a trial by two doctors linked to a mesh device. The hospital was unaware of a resulting research paper supporting the device until a formal complaint. In a video obtained by the Herald, one of the doctors tells a conference he was "flying a bit blind" on an "initial group" of 40 women at the hospital who received the mesh. The alleged research fraud is being investigated.
· The TGA in 2013 considered imposing a "first ever black box warning" on mesh devices, two years after the American FDA warned that serious complications from mesh surgery were "not rare". A TGA working group discussing the proposal was questioned about "whether a warning of this nature could increase surgeons' liability".
· The TGA was warned by an expert review committee as early as 2008 that erosion of mesh tape into women's vaginas or rectums were "common adverse events with these types of devices", but it did not deregister the first transvaginal mesh device until more than six years later.
· In its 2013 review the TGA conceded "significant under-reporting" of injuries to women after mesh surgery because only manufacturers are mandatory reporters of adverse events. The TGA estimated "it only receives 10-20 per cent of all events". It noted that "surgeons do not have a strong awareness of Australia's adverse event reporting systems" and the TGA only had the legislative power to compel manufacturers to report injuries to women.
· The TGA conceded in 2013 that the exact percentage of injuries to women caused by mesh will never be known because it had "no way" of establishing the total number of mesh devices implanted in Australian women based on Medicare payments. The medical benefits system did not distinguish between surgical procedures, with or without mesh. The 2013 review was also told only 50 per cent of surgeries would be captured by medical benefits data.
Ms Chisholm, and group member Kim Blieschke, who met with Senator Hinch to argue for a Senate inquiry, said the global transvaginal mesh scandal was "finally going to be put in the spotlight".
"We feel like the wheels are turning and finally the women have some hope," Ms Chisholm said.
A spokesperson for Medtronic, which acquired former Tyco parent company Covidien, said it estimated up to 15,800 women had, or would, make claims against it alleging personal injuries from mesh devices previously manufactured by Covidien subsidiaries, including the IVS Tunneller.
By March 1 it had settled about 70 per cent of claims. The litigation did not involve any active businesses within Medtronic.
http://www.smh.com.au/national/health/pelvic-mesh-devices-hit-by-allegations-of-research-fraud-experimental-surgery-on-thousands-of-women-20170313-guxclj.html
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Newcastle doctor and Queensland colleague sounded alarm on mesh in 2003
Mar 14, 2017 | Newcastle Herald
By Joanne McCarthy
IN 2003 two doctors – Newcastle’s “grand old man” of obstetrics and gynaecology, Dr Alan Hewson, and his Brisbane colleague, Dr Chris Maher – wrote a paper sounding the alarm about a pelvic mesh procedure after treating women with serious complications following mesh surgery.
The procedures “cannot be recommended”, they wrote.
Two years later Dr Hewson and Dr Maher co-wrote another paper with colleagues in Germany and Switzerland, based on severe mesh complications seen in women in the three countries, including women as young as 35 unable to have sex, with chronic infections not responding to antibiotics, mesh tape eroding into their vaginas, discharges, bleeding and extreme, disabling pain.
The paper highlighted the lack of published data on the safety and efficacy of intravaginal slingplasty techniques and the mesh developed by Tyco in its IVS Tunneller. The doctors repeated that “these procedures cannot be recommended” and should be used in “controlled clinical trials only”.
For the next decade Dr Maher, who became an Associate Professor and one of Australia’s leading experts on pelvic prolapse surgery in women, continued to sound the alarm as mesh device manufacturers aggressively marketed them, regulators continued clearing devices for use without new evidence, and doctors’ professional organisations and teaching colleges remained largely silent.
Associate Professor Maher was the target of heavy criticism from some sections of his profession, said Dr Hewson, 89, and now retired.
“He was the honest guy, the whistleblower, saying: ‘Come on guys, we shouldn’t be doing this’,” said Dr Hewson.
The clearance of transvaginal mesh – where mesh tape is implanted in women via the vagina rather than abdominal surgery to treat incontinence and prolapse complications after childbirth – was “one of the real scandals of the past decades”, Dr Hewson said.
He was the honest guy, the whistleblower, saying: ‘Come on guys, we shouldn’t be doing this’.- Newcastle retired Dr Alan Hewson
“The (American) Food and Drug Administration made an awful mess of it. They should have been more careful about letting these devices on the market but the horse has bolted, sadly.
“The (Australian) Therapeutic Goods Administration, they have got something to answer for. The government regulator made errors. There was enough evidence there 10-15 years ago to pull the shutters down on mesh devices.
“A lot of the patients did not give valid informed consent. They did not know what they were getting.”
Dr Hewson said he warned Hunter specialists of his concerns about mesh and that he did not use it.
In a 2013 submission to the New Zealand Parliament which was considering an inquiry into how mesh devices were cleared for use in New Zealand, Associate Professor Maher strongly criticised pelvic floor specialists, regulators, medical colleges and professional organisations.
Pelvic floor clinicians had “failed to demand a satisfactory level of evidence regarding the safety and efficacy of a product prior to its utilization”, which he described as a “completely unsatisfactory scenario”.
Gynaecologists “appeared very receptive” to mesh and “many were surprised” to later find devices were cleared for use in America and Australia without premarket demonstrations of safety and efficacy, he said.
In America alone in 2010 doctors implanted an estimated 75,000 devices.
In Australia just one company, the Adelaide firm TFS Manufacturing owned by former national champion basketballer and Newcastle Falcons player Paul Zadow, sold more than 15,700 devices from 2006. More than 60 mesh devices for prolapse surgery were cleared for use in Australia from 2002.
In November, 2014 TFS became one of the first mesh devices in the world to be deregistered.
An appeal by TFS Manufacturing against the deregistration is being heard in the federal Administrative Appeals Tribunal. In a recent decision before a full hearing later this year, the tribunal was told the TFS device was cleared for use in Australian women based on “very poor” evidence.
Between 2002 and 2011 – when the American Food and Drug Administration finally issued a warning that complications with mesh devices were “not rare” - it was “manufacturers and their paid key opinion leaders” who “aggressively marketed” the devices, and taught the theory and surgical techniques, Associate Professor Maher said.
Elected educational and representative bodies were largely silent on this issue until the 2011 safety notifications.- Associate Professor Chris Maher
“Elected educational and representative bodies were largely silent on this issue until the 2011 safety notifications.”
The only medical colleges to provide guidance on transvaginal mesh devices until the 2011 FDA warning were the Royal Australian and New Zealand College of Obstetrics and Gynaecology in 2009, and its Canadian counterpart in 2011, he said.
The International Urogynaecology Association (IUA) and the American Urogynaecology Society (AUGS) did not issue any guidance before 2011. In his paper Associate Professor Maher said members of the IUA declared links with mesh manufacturers in statements after 2011, and at least three declared they received royalty payments from mesh manufacturers.
The professional organisations also accept sponsorship from drug and device manufacturers.
It was women and their lawyers who forced regulators to act on mesh by finally demanding clinical evidence of safety and efficacy – in Australia from August, 2014, Associate Professor Maher said.
“The overwhelming group that has influenced clinician behaviour relating to transvaginal mesh are the litigation lawyers and advertising undertaken to the general community,” he said.
In his 2013 paper he heavily criticised the FDA for clearing a mesh device in 2001, modified from an Australian mesh delivery device, that had no “predicate case” – or similar device with associated evidence – to rely on to approve its use for prolapse surgery.
The FDA’s finding that “any differences in the devices do not raise new questions of safety and efficacy” was “factually incorrect”, he said.
The device with its faulty clearing for prolapse became the predicate case for multiple subsequent prolapse mesh device clearances in America, and later Australia, he said.
He recommended substantial changes in regulatory approvals for devices, an “arm’s length” relationship between manufacturers and doctors, and requiring college directors to be free of any conflicts of interest.
“It is vital that we review the events that allowed the women we are trained to serve to be exposed to unknown risk during the surgical treatment of pelvic organ prolapse,” he said.
http://www.theherald.com.au/story/4522153/whistle-was-blown-on-pelvic-mesh/
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Transvaginal mesh devices under the spotlight
Mar 14, 2017 | Bendigo Advertiser
By Joanne McCarthy
“WeE were guinea pigs, we just didn’t know until it was too late,” said Caz Chisholm, who can barely contain her rage against doctors, regulators, the manufacturers of transvaginal mesh devices and a health system that has catastrophically failed women.
She set up the Australian Pelvic Mesh Support Group in November, 2014, after flying to America to have mesh removed from her body after severe complications.
She flew to Canberra from Western Australia two years later to meet Victorian Senator Derryn Hinch and argue for a Senate inquiry into transvaginal mesh, and rallied women in February when an inquiry was announced.
Ms Chisholm accuses doctors of “closing ranks” when women complained of catastrophic injuries after mesh surgery, including disabling pain, an inability to urinate, sit or have sex, the erosion of mesh tape into women’s vaginas and rectums, chronic infections and bleeding.
She accuses manufacturers of putting profits before women’s lives.
She accuses Australia’s Therapeutic Goods Administration (TGA) of not only failing women by approving transvaginal mesh devices without clinical evidence of safety and efficacy, but having an adverse events reporting system that completely failed to detect injuries to women, and of failing to respond quickly and appropriately when the extent of serious complications became apparent.
“I set up the support group because it was basically the only place for women to go,” Ms Chisholm said.
“Current systems still don’t allow the true extent of this disaster to be known. For so many women you’re left feeling you’re the only one experiencing these extreme consequences. It’s only when women join the group they are able to say ‘Oh my God, it’s not just me. I’m not going crazy’.”
Ms Chisholm said many women were not told the risks of transvaginal mesh surgery before it was implanted, and so did not give informed consent.
“If you’ve not consented to what is going to happen to you, and you wake with serious complications, you’re not only dealing with the physical impacts of mesh but the emotional trauma of feeling violated,” Ms Chisholm said.
“It is a violation of your body to have something in there that you didn’t consent to.”
Ms Chisholm said the Senate inquiry, which is receiving submissions until May and will hold public hearings around the country mid-year, was a chance to “hold regulators to account for being responsible for destroying women’s lives”, and question doctors and the medical profession about why they used mesh in women without requiring evidence it was safe and worked.
“It’s just seeing justice done. That’s why it’s important,” Ms Chisholm said.
http://www.bendigoadvertiser.com.au/story/4527837/we-were-guinea-pigs/?cs=4060
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