Australia withdraws J&J pelvic mesh

Johnson & Johnson withdraws pelvic mesh device from Australian market

Regulator says the mid-urethral vaginal sling, subject of a class action, is no longer being imported

Melissa Davey @MelissaLDavey

Mon 22 Jan 2018 23.14 EST

• Pharmaceutical giant Johnson & Johnson has withdrawn from the Australian market its supply of the vaginal mesh device that is the subject of a class action before the federal court.

On Tuesday a spokeswoman for Australia’s medical devices regulator, the Therapeutic Goods Administration, confirmed to Guardian Australia that the mid-urethral vaginal sling devices, used to treat stress urinary incontinence in women, were no longer being imported.

The devices are produced by the Johnson & Johnson company Ethicon and no longer appear on the Australian Therapeutic Goods Register, which is a list of products that can be lawfully supplied in Australia. The TGA has not responded to questions about whether the removal of the products from the register also means that products already on hospital shelves cannot be used by surgeons.

The TGA asked all manufacturers of transvaginal sling and mesh devices to update the “instructions for use” on transvaginal mesh and tape products before 17 January to include information about possible adverse events such as severe chronic pain, groin pain and bladder perforation.

According to the TGA, Johnson & Johnson did not meet this deadline and withdrew the supply of their mid-urethral sling devices to enable them to consider their options. A list of pharmaceutical companies that have met the new requirements has been made public.

The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson, told Guardian Australia he had written to all members to alert them to the development. It was his understanding that Johnson & Johnson slings already on hospital shelves could still be used but new supplies could not be imported.

Robson said he did not have “exact figures”, but the Johnson & Johnson devices were probably the most widely used by surgeons to treat incontinence.

“What I have heard is once the stock on the shelf is gone that’s it, and many hospitals, if not most, are looking at other options including other brands of urethral tape, which are still available,” Robson said.

“The feedback is some places are exploring transition arrangements so women can be offered other similar products. What I also wrote to our members yesterday was that it is clear mid-urethral tapes are the most appropriate response to incontinence which has not responded to other clinical treatment. We recirculated a Cochrane review that shows that mid-urethral tapes are the most appropriate treatment when used appropriately, and are very safe.

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“In fact, I think it’s regrettable it won’t be available for a while, but there are other similar products.”

The Johnson & Johnson/Ethicon implant became the subject of a class action run by Shine Lawyers in 2017, with 700 Australian women alleging that faulty pelvic mesh implants caused them debilitating pain.

Similar class actions involving thousands of women are also under way in the UK and US. More than 100,000 transvaginal mesh lawsuits have been filed in the US, the largest number against Johnson & Johnson, the manufacturer of the most commonly used meshes. Shine Lawyers alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients.

A Senate inquiry has examined whether any financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants; the lack of data available on how many procedures were performed; and the type and incidence of health problems woman have experienced.

The class action is due to return to the federal court in Sydney on Monday.

Johnson & Johnson has been contacted for comment.

https://www.theguardian.com/society/2018/jan/23/johnson-johnson-withdraws-pelvic-vaginal-mesh-device-from-australian-market

Slow Justice: A Slap on the Wrist of J&J Corporate Perpetrators

In Second Bellwether Trial, NJ Jury Awards $15M in Ethicon Mesh Case

A Bergen County jury returned a $15 million verdict Thursday against Johnson & Johnson subsidiary Ethicon in a suit over alleged defects in its Prolift pelvic repair product.

By Charles Toutant | December 14, 2017 at 07:15 PM

Ethicon mesh

A Bergen County jury returned a $15 million verdict Thursday against Johnson & Johnson subsidiary Ethicon in a suit over alleged defects in its Prolift pelvic repair product.

The verdict, for $4 million in compensatory damages to plaintiff Elizabeth Hrymoc, $1 million in compensatory damages to her husband, Tadeusz Hrymoc, and $10 million in punitives, was awarded after a three-week trial before Superior Court Judge Rachelle Harz.

Johnson & Johnson has promised to appeal and says it stands by its pelvic mesh products.

Thursday’s verdict is the second in a bellwether pelvic mesh case in New Jersey. It follows another for $11 million that was awarded in 2014. That verdict was later upheld by the Appellate Division, and the Supreme Court declined to take up the case.

Hrymoc, 71, who suffered vaginal pain after surgery to implant the product in 2008, is unable to have sexual intercourse or undergo a pelvic exam as a result of her injuries, said plaintiffs lawyer Adam Slater of Mazie Slater Katz & Freeman in Roseland.

The jury found that the Prolift pelvic repair system was defectively designed and failed to contain adequate warnings, and that the TVT-O system for treatment of stress urinary incontinence failed to contain adequate warnings. The punitive damages were awarded based on a finding that the Prolift design and warnings demonstrated willful and wanton disregard for the health and safety of the plaintiff. The jury, including one attorney and numerous others with master’s degrees, was “very sophisticated,” Slater said.

The resolution of the Hrymoc case means that “every single important legal ruling has been made, so trying these cases going forward is going to be very streamlined,” according to Slater. Those legal issues include what evidence is admissible on particular issues, and what jury charges are allowed, he said.

“Those orders now apply in every case. It’s going to be much easier and much more efficient. That’s very, very significant,” said Slater.

Also of note is that punitive damages have been awarded in both New Jersey Prolift suits, which requires a finding, by an enhanced, clear-and-convincing evidence standard, that the defendant showed a wanton disregard for the plaintiffs’ safety and health, Slater said.

Johnson & Johnson spokeswoman Mindy Tinsley said in a statement in response to Thursday’s verdict: “Ethicon intends to appeal this verdict, as we believe the evidence showed that the company appropriately informed surgeons of the pertinent complications and that the products were properly designed and studied.”

About 2,000 pelvic mesh suits against Ethicon are still pending in Bergen County, and in 2018 the court is likely to begin trying those cases two or three at a time, according to Slater.

About 150 pelvic mesh cases against Bard are also pending in New Jersey, he said.

In September, a Philadelphia jury returned a $57.1 million verdict against Ethicon in Ebaugh v. Ethicon. That verdict was composed of $7.1 million in compensatory damages and $50 million in punitive damages.

Tinsley’s statement continued: ”All surgeries to treat pelvic organ prolapse and stress urinary incontinence have risks, including Prolift and TVT-O, and Ethicon is always concerned when a patient experiences surgical complications. The majority of surgeons around the world continue to agree that midurethral slings like TVT-O are a suitable first line surgical option to treat stress urinary incontinence. Many surgeons also continue to support the use of pelvic mesh to treat prolapse as an important treatment option for women because the vast majority of women experience improvement in their symptoms and quality of life. Ethicon stands by, and will continue to defend, our pelvic mesh products in litigation.”

Slater was joined at trial by his firm’s David Mazie, David Freeman, Cheryll Calderon, Karen Kelsen and David Estes.

Ethicon’s lawyers included William Gage of Butler Snow in Ridgeland, Mississippi; Judith Wahrenberger of Ruprecht Hart Weeks Ricciardulli in Westfield; Kelly Crawford of Riker Danzig Scherer Hyland & Perretti in Morristown; and Philip Combs of Thomas Combs & Spann in Charleston, West Virginia.

Surgical Mesh: Harm-for-Profit Crimes Against Women

Mesh Lawsuits

$57.1 Million Verdict Against Johnson and Johnson

$57.1 million was awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.

$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal both cases to a higher court.

Transvaginal mesh bellwether trials and settlements are updated as follows:

MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 38,956 Total Closed: 7718  Past verdicts and settlements include:

• Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
• Edwards v. Ethicon, Inc., et al., 2:12-cv-09972-  Dismissed
• Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
• Carolyn Lewis v. Ethicon, et al. Defense Judgment
• Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
• Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed

MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,127  Total Closed: 17,248

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation–  Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs.  Total Cases: 15,491  Total Closed: 10,452  Past verdicts and settlements include:

• Wise, et al. v. C. R. Bard, Inc. – Settled
• Donna Cisson v. Bard, Inc.  – $2 Million Verdict
• Wanda Queen v. Bard, Inc. 2:11-cv-00012  – Settled
• Carolyn Jones v. Bard, Inc. 2:11-cv-00114 – Settled

MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Settlements in process with no trials scheduled. Total Cases: 25,029   Total Closed: 15,101   Past verdicts include:

• Jeanie Blankenship – $4.25 million +  $1 million punitive damages
• Chris Wilson – $3.75 million +  $1 million punitive damages
• Carol Campbell – $3.25 million + $1 million  punitive damages
• Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
• Juana Betancourt – $6.5 + million
• Mania Nunez – $6.7 + million; and
• Margarita Dotres – $6.7 + million;
• Amal Eghnayem – $6.7 + million

MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al.  Total Cases: 629 Total Closed: 123

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled and the judge is conducting settlement conferences. Total Cases: 2610 Total Closed: 2397

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125

Transvaginal Mesh Verdicts 

A chronology of the verdicts, settlements, manufacturers, products, and jurisdictions follows:

1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA
2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  – TX
6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX
10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV
15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
18. 2/15: Settled – Wise v. Bard in the MDL
19. 3/15: Settled  – Bellew v. Ethicon (Prolift) in the MDL;
20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima –  TX
24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) –  PA
26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT)  – PA
28. 4/17:  $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
29. 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
30. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA

TVM Verdicts and Trials

On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant. 

This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction. 

On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th,  2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.  

As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements.  Boston Scientific, Coloplast, AMS and Bard have begun offering settlements. 

A  California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed  because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice.

Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market. 

Bard Bellwether Case Settles Before Trial

Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount.  On February 12, 2015,  Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”

$26.7 Million and $18.5 Million Verdicts Against Boston Scientific 

$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded  $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include: 

1. Amal Eghnayem – $6.7 + million;
2. Margarita Dotres – $6.7 + million;
3. Mania Nunez – $6.7 + million; and
4. Juana Betancourt – $6.5 + million

The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include: 

1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages;
2. Chris Wilson – $3.75 million +  $1 million punitive damages;
3. Carol Campbell – $3.25 million + $1 million  punitive damages;
4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages

Transvaginal Mesh Adverse Events

Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:

• erosion through the vaginal tissue
• mesh contraction
• mesh extrusion
• inflammation
• fistula
• infection and abscess
• pain
• blood loss
• chronic and acute nerve damage
• pudendal nerve damage
• pelvic floor damage
• scar tissue
• chronic pelvic pain
• urinary problems and/or incontinence
• recurrence of prolapse
• bowel, bladder, and blood vessel perforation
• dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications. 

In July 1, 2012, Bard stopped selling the Avaulta Mesh in the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers 

Ethicon

• Secure
• Prolift
• Prolift +M
• Gynemesh/Gynemesh PS
• Prosima
• TVT
• TVT-Obturator (TVT-O)
• TVT-SECUR (TVT-S)
• TVT-Exact
• TVT-Abbrevo

C. R. Bard

• Align
• Avaulta Plus™ BioSynthetic Support System
• Avaulta Solo™ Synthetic Support System
• Faslata® Allograft
• Pelvicol® Tissue
• PelviSoft® Biomesh
• Pelvitex™ Polypropylene Mesh
• PelviLace
• InnerLace
• Uretex

American Medical Systems 

• SPARC®
• Mini-Arc
• Apogee
• Elevate
• Monarc
• In-Fast
• BioArc

Boston Scientific

• Obtryx® Curved Single
• Obtryx® Mesh Sling
• Obtryx Transobturator Mid-Urethral Sling System
• Prefyx Mid U™ Mesh Sling System
• Prefyx PPS™ System
• Uphold Vaginal Support System
• Pinnacle Pelvic Floor Repair Kit
• Advantage Transvaginal Mid-Urethral Sling System
• Advantage Fit System
• Solyx SIS System

Coloplast

• T-Sling-Universal Polypropylene Sling
• Aris-Transobturator Sling System
• Supris-Suprapubic Sling System
• Novasilk-Synthetic Flat Mesh
• Suspend-Tutoplast Processed Fascia Lata
• Exair-Prolapse Repair System
• Axis-Tutoplast Processed Dermis
• Restorelle
• Smartmesh
• Omnisure
• Minitape

Cook 

• Surgisis

http://www.carolynstclair.com/trucking-accidents/practice-areas/transvaginal-mesh/

AMS (American Medical Systems,now Endo and J&J (Johnson & Johnson/JNJ) HARM Women FOR PROFIT in AU

Australian Medical Association president confirms AMA WA(Western Australia)’s role in pelvic mesh scandal

• Joanne McCarthy  AUGUST 22 2017 - 12:11PM

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The Australian Medical Association acted as exclusive distributor of an Australian-invented pelvic mesh device for women that helped spark a global pelvic mesh scandal after it was sold and registered for use in America in 2001.

The AMA's marketing of the Intravaginal Sling (IVS) Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse, despite women's reports of complications in Western Australian public hospital trials from as early as 1989, was "a long way from our proudest hour", said current AMA president Dr Michael Gannon.

Australian Medical Association national president Dr Michael Gannon confirmed the AMA promoted and distributed a pelvic mesh device for women that helped spark a global pelvic mesh scandal. 

"It is unfortunately the case that many women have been injured by these kinds of operations. To call this a tragedy is not overstating it at all," he said, after confirming a wholly-owned subsidiary of the AMA's Western Australian branch promoted and exclusively distributed the IVS device.

It was a controversial decision that "I'm sure they now regret", and which some Perth gynaecologists continued to be unhappy about more than 15 years later, he said.

• 
  

"I can only answer that in good faith the AMA WA thought it was a good product. History will not judge that decision kindly. It already has not judged that decision kindly," Dr Gannon said.

His comments come only months after the Royal Australian and New Zealand College of Obstetricians and Gynaecologists conceded there was "very little robust information" of the long term safety of some prolapse mesh devices, despite estimates more than 30,000 Australian women received them.

The IVS Tunneller's sale to Tyco Health and registration in America in April, 2001 was used by pharmaceutical giants, including Johnson & Johnson, to register their own prolapse devices by arguing they were "substantially the same" as IVS and subsequent devices, without producing independent evidence of safety. They were then cleared for use in Australia.

More than 700 Australian women alleging serious and permanent injuries after pelvic mesh surgery for incontinence and prolapse are suing Johnson & Johnson in a Federal Court case in Sydney.

An Australian Medical Association document describing the IVS Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse in women.

Another 300 Australian women are registered for a second class action against American Medical Systems (AMS), which developed pelvic mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, after AMS argued it was "substantially the same" as the Australian-invented IVS Tunneller.

Dr Gannon, a Western Australian obstetrician and gynaecologist, said he was aware of "hundreds of operations" by Perth specialists trying to "remedy the damage" caused by mesh devices including the IVS.

Australian Pelvic Mesh Support Group members fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia. 

"I have been personally involved in the care of women who have suffered greatly from bladder dysfunction, bowel dysfunction and sexual dysfunction because of some of these devices," he said.

It was a "regulatory failure that so many individual women were damaged".

"The TGA (Therapeutic Goods Administration) takes great care when it looks at new medicines entering the market, but I don't think they are resourced to take the same care with devices. We would like to see them use the same blowtorch on devices as applies to medicines," he said.

Perth woman Jeanette McKinnon, who said she "wanted to vomit" several weeks ago when a specialist confirmed she was implanted with at least two mesh devices at the Bentley public hospital in 2004 and 2005, allegedly without her knowledge or consent, was outraged when told of the AMA's involvement.

"I'm absolutely horrified. I'm so angry I'm shaking. That this has been allowed to go on, and the AMA's been involved. How dare they? We're human beings," Mrs McKinnon said.

The IVS Tunneller device was developed during experiments on 13 large dogs in 1987 by inventor Dr Peter Petros and other Royal Perth Hospital doctors.

A WA East Metropolitan Health Service spokesperson confirmed Royal Perth Hospital approved a research study in 1989 into the IVS device and procedure. It was granted standard clinical practice status by the hospital's ethics committee in 1993.

A Medical Journal of Australia report in July, 1994 acknowledged many doctors were critical of the procedure.

In February 2001, only two months before the IVS Tunneller was cleared for use in America as an incontinence and prolapse device, the Royal Australasian College of Surgeons found there was "no peer-reviewed, good quality evidence available to determine the safety and efficacy of the IVS procedure to treat women's incontinence". There was no assessment of its use to treat prolapse.

In a paper in 2003 called "Intravaginal Sling Distress", three Australian specialists, including Newcastle gynaecologist Alan Hewson and Brisbane gynaecologist Chris Maher, reported "disconcerting complications" in women after IVS surgery, including infections, pain syndromes and "symptoms debilitating to the patient's and partner's quality of life".

"Until further data on the safety and efficacy of the IVS procedures is available they cannot be recommended," they concluded.

A 2010 Melbourne Mercy Hospital for Women review of 10 years of pelvic mesh surgery found the IVS device had significantly higher rates of pain, mesh erosion and infection complication rates than eight other devices reviewed.

Dr Petros did not respond to Newcastle Herald questions.

In a paper in 2012 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".

In a submission to a Senate inquiry into pelvic mesh devices, which will hold its second public hearing in Perth on Friday, Dr Petros referenced his 1990 paper produced after trialling the Intravaginal Sling procedure on "13 female mongrel dogs", in association with Royal Perth Hospital and the University of Western Australia.

-  Newcastle Herald

http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html

Australian Inquiry: Pelvic Mesh Causes Catastrophic Harm

A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries

Joanne McCarthy

4 Aug 2017, 5:30 a.m.

Determined: Women pelvic mesh victims leave the Federal Court in Sydney as a six-month class action against pelvic mesh manufacturer Johnson & Johnson takes place. A Senate inquiry is considering how mesh was cleared for use in Australia.

AUSTRALIA’S peak health care commission has told a Senate inquiry that up to 3000 Australian women have been left with injuries ranging from very serious to catastrophic after pelvic mesh surgery that is no longer recommended as a front line treatment.

The Australian Commission on Safety and Quality in Health Care was highly critical of specialist training, information to women about pelvic mesh risks, the treatment of women after serious mesh complications and the failure of doctors to respond when they sought help.

“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue,” commission chief executive, Adjunct Professor Debora Picone told the inquiry during a public hearing in Melbourne.

Commission clinical director Dr Robert Herkes said 40 women interviewed during consultations in four Australian cities had complications that were “undoubtedly overwhelming those women’s lives”.

“The bulk of the women were separated or divorced. Only one woman held down a job. For those women the complications were catastrophic,” Dr Herkes said.

Many of the women did not know they had been implanted with mesh devices until they searched for explanations for complications including chronic infections, disabling pain, erosion of the mesh into other organs and an inability to have sex.

“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue.

- Associate Professor Debora Picone

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“We’ve been extremely concerned by the issues raised by the women we’ve talked with about the informed consent process, and particularly the informed consent process in relation to mesh surgery to treat prolapse,” Professor Picone said.

“In fact some of the conversations we’ve had with women, informed consent has really been absent. There’s no question about that in our minds.”

She described “so-called patient information leaflets” about pelvic mesh surgery as “hopelessly inadequate”, and said the commission felt very strongly that “major steps” needed to be taken on credentialing of doctors who implant mesh devices.

The Senate inquiry into pelvic mesh was called after Australian Pelvic Mesh Support Group founder Caz Chisholm and other members spoke with Victorian Senator Derryn Hinch. He campaigned for an inquiry into “one of the greatest scandals against women in Australian history”.

It is hearing evidence from women who received mesh implants through the vagina for prolapse treatment – now not recommended as a front line treatment after complication rates of at least 10 per cent – and mesh for incontinence, with lower complication rates and recognised evidence of safety and efficacy.

At the first hearing day two doctors who gave evidence conceded they should have declared they were to appear as expert witnesses for Johnson & Johnson in the company’s defence of a class action brought by more than 700 women after mesh surgery for incontinence and prolapse treatment.

Dr Anna Rosamilia told the inquiry she “should have disclosed” that she would be giving evidence for the company after appearing as a representative of Monash Health at the inquiry.

“I wasn’t aware that I needed to,” she said.

Dr Peter Dwyer, who will also give evidence for Johnson & Johnson, told the inquiry most of these companies have got strict ethical protocols that they stick to, before conceding he was an expert witness for the company.

Dr Dwyer told the inquiry that specialist training on mesh surgery was “falling between the gaps a bit”.

“If they’re placed in the wrong place… I mean, patients have died from these devices. They’ve got to be placed correctly,” he said.

Mesh manufacturers, which have been training doctors, should not be left to train them, he said.

Medical colleges had been “very happy to pass this on to special interest groups to manage these problems”, he said.

In response to a question from Mr Hinch about mesh company representatives being present in operating theatres while women are being implanted with mesh devices via the vagina, Dr Dwyer said “on occasion the rep does come into the operating theatre”.

“It’s not unusual for them to come into theatre at times. As long as they’re not directing the operation or interfering in other ways,” Dr Dwyer said.

The inquiry will hold another public hearing in Perth on August 25.
http://www.theherald.com.au/story/4832324/peak-health-body-scathing-on-mesh-history/