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Ethicon Media Monitoring 7/6/2017
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Johnson & Johnson vaginal mesh trial begins in Australia
Jul 6, 2017 | FeirceBiotech
By Amirah Al Idrus
A trial involving more than 700 patients who were implanted with vaginal mesh or tape has startedin Australian federal court. The plaintiffs allege that Johnson & Johnson minimized the risk of the devices to patients and surgeons. -
Johnson & Johnson fields Aussie class action over pelvic mesh
Jul 6, 2017 | Tech Times
By Ted Ranosa
Hundreds of Australian women have launched a class action case against American drug maker Johnson & Johnson over its vaginal mesh implants, which they claim can cause debilitating and irreparable pain to users. -
Largest Class Action in Australia Blames J&J for Hundreds of Pelvic Mesh Injuries
Jul 6, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 5, 2017 ~ As the U.S. celebrated its Independence Day, more than 700 Australian women joined in a pelvic mesh trial blaming Johnson & Johnson for their mesh-related injuries. -
Port Pirie women report in national vaginal mesh implant complications survey
Jul 6, 2017 | The Recorder
By Patrick Martin
As a class action against medical giant Johnson & Johnson begins in New South Wales over the company’s pelvic mesh device, complications surrounding mesh implants have been reported at Port Pirie. -
Johnson & Johnson Vaginal Mesh Implant Lawsuit Case Begins in Australia
Jul 6, 2017 | Philly.com
Vaginal mesh implants sold by Johnson & Johnson caused severe pain, physical harm and, in some cases, ruined their lives, according to more than 700 Australian women in a class-action case that began Tuesday. -
Johnson & Johnson (NYSE:JNJ) face lawsuit in Australia for complications arising from vaginal mesh implants
Jul 6, 2017 | Benchmark Monitor
Australian women have brought a class-action case against Johnson & Johnson (NYSE:JNJ) over complications arising from vaginal mesh implants – a lawsuit that follows many others in the United States, Canada and Europe. -
AU Investigation Questions Ethics Behind Mesh Study
Jul 5, 2017 | Mesh Medical Device Newsdesk
An Australian public health watchdog is launching an investigation into whether two doctors participated in a pelvic mesh study and implanted women without the knowledge of the women or the hospital.
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Johnson & Johnson vaginal mesh trial begins in Australia
Jul 6, 2017 | FeirceBiotech
By Amirah Al Idrus
A trial involving more than 700 patients who were implanted with vaginal mesh or tape has startedin Australian federal court. The plaintiffs allege that Johnson & Johnson minimized the risk of the devices to patients and surgeons.
The class-action suit is being heard in the Federal Court in Sydney. In addition to failing to properly warn surgeons and patients of the devices’ risks, Johnson & Johnson did not test the devices adequately, The Guardian reported.
Specifically, the company “aggressively” marketed the treatment to surgeons while downplaying or not communicating the risks, said Tony Bannon, the lawyer representing the claimants.
“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” Bannon told the court.
Vaginal mesh is designed to treat pelvic organ prolapse and urinary incontinence, but lawsuits in several countries, including the U.S., have turned up numerous complications, including tissue death and bone erosion.
The plaintiffs in the Australian case said they experienced bleeding and severe discomfort during sexual intercourse after having the device surgically implanted, Reuters reported.
The trial is expected to run for six months.
Stateside, the lawsuits have been piling upfor J&J, which in 2012 stopped marketing four of its vaginal mesh products, and in 2016, earmarked more than $120 million to settle a portion of the lawsuits. However, this sum will only resolve between 2,000 and 3,000 of the more than 40,000 suits the company is facing.
In May this year, a Philadelphia jury awarded $20 million in damages to a plaintiff who had undergone multiple unsuccessful surgeries to remove her pelvic mesh device. But while J&J has been hit with a couple of whoppers—a Dallas jury has handed down a $500 million verdict and a $1 billion verdict in vaginal mesh cases—the company may catch a break, thanks to a Texas law that limits punitive damages.
http://www.fiercebiotech.com/medtech/j-j-vaginal-mesh-trial-begins-australia
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Johnson & Johnson fields Aussie class action over pelvic mesh
Jul 6, 2017 | Tech Times
By Ted Ranosa
Hundreds of Australian women have launched a class action case against American drug maker Johnson & Johnson over its vaginal mesh implants, which they claim can cause debilitating and irreparable pain to users.
More than 700 patients from all over Australia filed a lawsuit against Johnson & Johnson for allegedly failing to warn the public about the risks associated with its mesh implants. They also claimed that the devices were not fit to address the health issue they were made for, and that they were not properly tested before being made available.
As many as 8,000 women in Australia and thousands more in other countries depend on vaginal mesh implants to help deal with pelvic floors and urinary incontinence. Women often develop these conditions after they give birth.
The plaintiffs, however, argued that Johnson & Johnson's devices instead caused them to suffer excruciating pain after they began eroding into surrounding tissue and organs. They also became more susceptible to infections and complications because of the mesh's erosion. To make matters worse, the medical implants cannot be removed from the patients' bodies.
Some women also claimed that they still suffered from chronic pain even after they had further surgery done to address the issue.
The class action lawsuit is described as the largest such case ever to be filed in Australia. Shine Lawyers, the legal group representing the plaintiffs, said the commencement of the case is an important step toward justice, accountability and recompense.
Attorney Jan Saddler from Shine Lawyers explained that the biggest problem with the vaginal mesh implants is the severe damage they can cause to surrounding tissue and organs once they erode. The resulting chronic inflammatory response causes the patients to suffer debilitating pain.
Saddler added that the chronic pain has also led to relationship problems for affected women since they could no longer have any sort of sexual relationship. Those who could still have sex often experience severe pain because of the damage caused by the implants. Saddler pointed out that the patients' condition has severely affected their way of life.Johnson & Johnson's Vaginal Mesh Implants
According to Johnson & Johnson, it has sold more than 100,000 mesh products in Australia alone. Of the nine different medical devices mentioned in the class action lawsuit, the drug company has already pulled five from the market. So far, Australian regulators have not recalled any of Johnson & Johnson's mesh products.
In 2016, the U.S. Food and Drug Administration reclassified all pelvic mesh implants from being "moderate" to being "high risk" for patients. This made the products subject to stricter regulatory guidelines. The agency, however, has not issued any product recalls for the devices.
Johnson & Johnson argued that the use of its mesh implants has helped millions of women around the world deal with pelvic organ prolapse and urinary incontinence. The drug maker added that many of the patients who have had surgery experienced positive results.
http://www.techtimes.com/articles/211053/20170705/australian-class-action-case-filed-against-johnson-johnson-over-vaginal-mesh-implants.htm
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Largest Class Action in Australia Blames J&J for Hundreds of Pelvic Mesh Injuries
Jul 6, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 5, 2017 ~ As the U.S. celebrated its Independence Day, more than 700 Australian women joined in a pelvic mesh trial blaming Johnson & Johnson for their mesh-related injuries.
The largest class action in Australia may take up to six months.
It’s estimated as many as 100,000 Australian women may have been implanted with pelvic meshes made by Johnson & Johnson, C.R. Bard, Boston Scientific and AMS (American Medical Systems).
Tuesday, July 4, hundreds of those women took Johnson & Johnson (J&J) and its Ethicon medical device division to court in the largest class action in recent memory in Australia that’s expected to last up to six months.
This is the first legal action in Australia naming a defendant pelvic mesh maker. Australia fashions its regulatory approval of transvaginal mesh after the U.S. Food and Drug Administration (FDA) and the meshes named have all had FDA clearance for use.
This trial is headed by Shine Lawyers of Australia and will be held in federal court in Sydney.
Attorney Jan Saddler tells CTV News that the women involved have experienced chronic pain, mesh erosion, chronic inflammatory response, as well as an inability to have intimate relations.
Nine pelvic meshes are named, five are off the market, voluntarily recalled by J&J.
See MND story on J&J pelvic mesh voluntary recalls here.
ALLEGATIONS OF INJURY
Allegations are that while J&J aggressively marketed its meshes, it was negligent for failing to warn doctors and inform patients about the risks associated with transvaginal mesh. Testing was inadequate before marketing and the transvaginal mesh was defective in its design, not fulfilling the purpose for which it was created, says the plaintiffs’ complaint.
Gai Thompson tells CTV News in Canada, “No amount of compensation, money, could ever replace what we’ve lost with our lives, with our families, our health, our emotional health,” Thompson told reporters outside court. “My prayer is that this mesh would be banned and that no woman would suffer what we suffer.”
In a statement, Johnson & Johnson said the use of mesh to treat pelvic organ prolapse and urinary incontinence has successfully helped millions of women worldwide, and said the majority of women who undergo the surgery have had a positive result.
The New Jersey-based healthcare giant says it’s only aware of 200 complication reports in Australia, reports Reuters.
“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event,” spokeswoman Meshlin Khouri said in a statement.
NO RECALLS
In the U.S., an estimated 140,0000 women have filed defective product actions against mesh makers, many in multidistrict litigation (MDL).
Johnson & Johnson and its Ethicon division represent the largest number of U.S. actions filed, with 38,921 lawsuits filed in the federal MDL court as of today, July 5. Among those, 7,420 are listed as closed.
An Australian Parliament Committee is holding an inquiry into transvaginal mesh implants and a report is expected to be issued in November.
Australia has not recalled any pelvic meshes, following in the footsteps of the U.S. Food and Drug Administration, which also has not recalled or banned use of transvaginal mesh.
U.S. companies regularly send their medical devices overseas, including Australia. It’s estimated at least 100,000 transvaginal mesh medical devices have been sold in Australia.
Joanne Maninon tells The Guardian, “It can’t go on. There’s too many women who have gone through the pain, the complications, it’s lifelong.”
Women in Australia have not found doctors who can remove the mesh which is intended to be a permanent medical device. A few doctors in the U.S. have had some success at full mesh removal, best known among them is UCLA and Dr. Shlomo Raz.
OPENING DAY- VALUABLE MARKET
In the opening day of this class action, Tony Bannon spoke for the plaintiffs. He said the risks were either minimized or not communicated to the surgeon or patient by J&J.
“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” Bannon told the court.
He said the company saw a “valuable market” to be gained and convinced doctors it would be easy and quick to implant a pelvic mesh device.
Bannon quoted one of the French Ethicon team, Bernard Jacquetin, who said he wouldn’t like his wife to undergo that treatment and, “I don’t think I’m alone.”
Jacquetin was a consultant to J&J who received royalties from the healthcare giant.
Read about him from the Linda Gross trial held in New Jersey in 2013 here.
MORE CLASS ACTIONS AHEAD
News.com.au reports another 300 women in Australia have enrolled in a second class action lawsuit against American Medical Systems (AMS). The AMS Apogee was developed in Australia and cleared for use in the U.S. by the FDA in 2004.
It was quietly removed from the market by AMS. Read MND about AMS recalls here.
Australia’s regulatory authority, the Therapeutic Goods Administration (TGA), has not banned mesh devices in that country, similar to the U.S. Food and Drug Administration which, despite a Safety Communications that implant injuries are “not rare,” has taken no action to curtail pelvic mesh implantation.
In the U.S., there are approximately 140,000 lawsuits pending against seven mesh makers and an unknown number of cases have been prepared for settlement but have not been filed.
Besides Australia and the U.S., J&J/Ethicon is facing defective product lawsuits over its pelvic mesh in Canada, England, Israel, Italy, Belgium, the Netherlands, Scotland and Venezuela. ###
LEARN MORE
Mesh News Desk, June 2012- J&J Will Remove Four Meshes From the Market
http://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/MND, Day 20 Linda Gross Trial , February 8, 2013
http://www.meshmedicaldevicenewsdesk.com/day-20-linda-gross-v-ethicon-medical-director-mesh-exposure-15/MND, Australian Inquiry into TVM leads to Inquiry and Trial, March 16, 2017
http://www.meshmedicaldevicenewsdesk.com/australian-investigation-transvaginal-mesh-leads-trials-senate-inquiry/http://www.meshmedicaldevicenewsdesk.com/largest-class-action-lawsuit-australia-blames-jj-hundreds-pelvic-mesh-injuries/
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Port Pirie women report in national vaginal mesh implant complications survey
Jul 6, 2017 | The Recorder
By Patrick Martin
As a class action against medical giant Johnson & Johnson begins in New South Wales over the company’s pelvic mesh device, complications surrounding mesh implants have been reported at Port Pirie.
The Victorian-based not-for-profit consumer advocate, Health Issues Centre, conducted a survey into the impact of Transvaginal Mesh Implants for submission to a federal Senate inquiry.
More than 2000 women have been surveyed by HIC across Australia, with five women from Port Pirie responding to the survey. The technology has been used to treat complications caused by childbirth.
Of those respondents who had implants, about half claim to have been adversely affected, citing problems such as chronic incontinence, abdominal pain, painful intercourse and marital breakdown.
The Senate inquiry was seeking to understand the extent of the technology’s use in Australia – no records of mesh plant procedures performed in Australia have been kept.
Health Issues Centre chief executive officer Danny Vadasz said while the figures are just the “tip of the iceberg”, they are finally providing a clearer picture of the unfolding tragedy.
“Even the Therapeutic Goods Administration, which is conducting its own due diligence into the adverse impact of the implants, has had minimal success,” Mr Vadasz said.
“From July 2012 to 1 June 2016, it only received 99 adverse events reports involving urogynaecological surgical meshes.”
Mr Vadasz believes the transvaginal mesh tragedy will eclipse the Thalidomide disaster of the ‘50s and ‘60s which is estimated to have affected approximately 200 women across Australia.
The class action against Johnson & Johnson in NSW is being filed by 700 women.
The Australian Commission on Safety and Quality in Health Care estimates 100,000 women have had pelvic mesh implants since the late 1990s, but the number of women who have been adversely impacted is unknown.
The HIC’s survey and study is ongoing and can be accessed online.
The findings of the Health Issues Centre survey as of May, 2017:
· 73% of the 1,571 respondents had undergone mesh implants. This equated to 1,141 women.
· 49% (or 559) of the 1,141 women said they experienced adverse effects from their mesh implant. Of these, 415 cited incontinence, 318 abdominal pain, 313 pain during intercourse and 127 breakdown of their marriage or other personal relationship.
· 41 % or 456 of the women who had been adversely impacted believe they were not fully informed before agreeing to the procedure. Another 237 or 22% felt things had not gone according to what they had originally been told, leaving only 414 or 35% that believe they had made an informed choice.
· 203 or 34% of the women reported their adverse impact as “discomforting” while 183 or 30% said it was “debilitating” and 73 or 12% “unendurable”
· While 479 or 61 % of the women who had been adversely impacted sought remedial medical assistance, only 10.6% or 40 reported this made things better. For 40% or 155 it didn’t make any difference while for 44 or 11% it made matters worse. 39% or 158 were simply told there was nothing that could be done.
· 48% of overall respondents were over the age of 60.
http://www.portpirierecorder.com.au/story/4772227/mesh-implants-impact-locals/
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Johnson & Johnson Vaginal Mesh Implant Lawsuit Case Begins in Australia
Jul 6, 2017 | Philly.com
Vaginal mesh implants sold by Johnson & Johnson caused severe pain, physical harm and, in some cases, ruined their lives, according to more than 700 Australian women in a class-action case that began Tuesday.
The lawsuit alleges that Johnson & Johnson was negligent for not properly warning doctors and patients about the risks associated with the devices, that the implants were not fit for the purposes for which they were designed, and the testing prior to the devices being marketed was inadequate, the Associated Press reported.
The trial is expected to last six months.
Patients in the United States, United Kingdom and Canada have filed tens of thousands of lawsuits against Johnson & Johnson and other pelvic mesh manufacturers over the devices used to treat urinary incontinence and repair pelvic organ prolapse, the AP reported.
The lawsuits say the devices caused women chronic and often debilitating pain, infections, loss of sexual function and incontinence. In 2014, Irish medical device maker Endo International agreed to pay $830 million to settle more than 20,000 personal injury lawsuits related to its vaginal mesh implants, the AP reported.
http://www.philly.com/philly/health/topics/HealthDay724296_20170705_Health_Highlights__July_5__2017.html
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Jul 6, 2017 | Benchmark Monitor
Australian women have brought a class-action case against Johnson & Johnson (NYSE:JNJ) over complications arising from vaginal mesh implants – a lawsuit that follows many others in the United States, Canada and Europe.
Johnson & Johnson (NYSE:JNJ) shares edged up 0.46% to $132.90 on Monday.
The claim, which is being heard in Australia’s Federal Court, said patients had suffered chronic pain, bleeding and severe discomfort during sexual intercourse since having the mesh surgically implanted. The devices are used to treat stress urinary incontinence and pelvic organ prolapse. The Australian action was brought on behalf of more than 700 claimants.
http://www.benchmarkmonitor.com/johnson-johnson-nysejnj-face-lawsuit-in-australia-for-complications-arising-from-vaginal-mesh-implants/231726
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AU Investigation Questions Ethics Behind Mesh Study
Jul 5, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 5, 2017 ~ An Australian public health watchdog is launching an investigation into whether two doctors participated in a pelvic mesh study and implanted women without the knowledge of the women or the hospital.
The Victoria Health Minister, Jill Hennessy, is behind an investigation into a Melbourne public hospital. Victoria is a state in southeastern Australia.
Allegedly Dr. Richard Reid and Dr. Peter Petros assisted Dr. Max Haverfield in 2010 and 2013 without alerting the public or the hospital, and despite some conflicts of interest.
The paper was written by gynecologist Dr. Max Haverfield and published in 2015. See it here.
It concluded the device is “safe and effective” but Northern Hospital has no record of the trial or ethics committee approval, reports McCarthy.
The research study says “Ethics approval was obtained by the Ethics Committee, The Northern Hospital/Northern Health. Safety of the study was monitored throughout. Written informed consent was obtained from all patients.”
Dr. Petros is the inventor of the TFS and was director of TFS Manufacturing at the time of the alleged ethics violation.
At the time, he and Dr. Richard Reid were being monitored by the NSW (New South Wales) Medical Council after it had received complaints from women injured allegedly by pelvic mesh surgery.
TFS was taken off the market in November 2014 because of a lack of evidence on its safety and efficacy.
The 24-month study included women who experienced grade two to four prolapse.
Here are the archives- coverage from Newcastle Herald.
Reporter McCarthy is recognized as the persistent journalist who uncovered wrongdoings of the Catholic and Anglican churches concerning child sexual abuse.
Her reporting is credited with the creation of the Royal Commission into Institutional Responses to Child Sexual Abuse.
She has since moved onto transvaginal mesh and the harm it has caused.
Mesh News Desk has written about Dr. Petros application to re-invent the TFS as a treatment for sagging breasts. See the story here. #
http://www.meshmedicaldevicenewsdesk.com/au-investigation-questions-ethics-behind-mesh-study/
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