UK Parliament Hearing About Implant Device FAILURE

Woman who lives in constant pain calls for op to be banned 

Deborah, left, with Owen Smith and Sling the Mesh - Kath Sansom 

Published: 09:34 Friday 04 August 2017  FiDA highlight

A woman who lives her life in excruciating pain after a medical operation four years ago, joined other women at Parliament last month in a campaign to get the surgical procedure banned in the UK. The Sling the Mesh Campaign is calling for an operation using pelvic mesh implants to be banned after thousands of women suffered serious health complications. Deborah Wood, of Bexhill, underwent an operation in 2013 but after experiencing numerous negative side-effects, including extensive bleeding and extremely painful sexual intercourse, she began the process of having the mesh removed. She said: “I have had five operations to remove the tape and I still have a small amount of tape and arms left in. I don’t think I can go through anymore operations. “For the past four years, I have been in chronic pain 24/7. I have nerve damage in my legs – the pain in my legs is constant, they feel like someone is driving red hot glass into my legs. I get a lot of pain in my vagina and my pubic bone. I don’t have any sensation in my bladder so I can’t tell when it is full or empty, I have to use catheters. “I am now left permanently disabled. I cannot walk very far, I need to use crutches, a wheelchair and mobility scooter. I have just been diagnosed with PTSD and I am now on antidepressants. “Before all of this happened I was at university getting a degree in photography and had a photography studio. I had to give that all up. “I am 49 years old and the thought I have to live the rest of my life in pain scares me.” Deborah travelled to London on July 18 with other members of the Sling the Mesh Campaign to meet with Labour MP Owen Smith, who has set up an All Party Parliamentary Group into mesh surgery. The mesh patch or vaginal tape, also known as TVT, TVTO and TOT, are used to treat incontinence and prolapse, often caused by childbirth. Politicians called for mesh operations to be suspended in Scotland in June 2014 and in May 2017, Scottish health secretary Shona Robison called for an independent expert to review a mesh safety report. The English mesh review was due out at the end of July 2017. Deborah added: “The TVT/TOT must stop in the UK. We need to get the public aware to prevent more horrific injuries. This mesh has ruined my life.” Visit https://slingthemesh.wordpress.com/ for details.

Read more at: http://www.bexhillobserver.net/news/health/woman-who-lives-in-constant-pain-calls-for-op-to-be-banned-1-8087506

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

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

Joanne McCarthy

4 Jul 2017, 12:04 p.m  FiDA highlight

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Ms Manion was visibly upset through some of the evidence.

The hearing continues.

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

Jury Verdict: Johnson and Johnson to pay for 'malice' toward patient.

UPDATE 2-Johnson & Johnson ordered to pay $5.7M in California mesh trial

Thu Mar 5, 2015 4:04pm EST

By Jessica Dye

(Reuters) - A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.

The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.

The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.

Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.

Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.

Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."

Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.

Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.

Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.

The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123. (Reporting by Jessica Dye in New York; editing by Chris Reese, Alexia Garamfalvi and Lisa Von Ahn)

http://www.reuters.com/article/2015/03/05/johnson-johnson-mesh-verdict-idUSL1N0W728U20150305

Plaintiff awarded $1.2M by Texas jury for defective surgical mesh product

Jurysays Johnson & Johnson must pay $1.2M over defective vaginal-mesh implant

By Bloomberg News

 April 04, 2014 at 11:38 AM

Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.

Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.

J&J, based in New Brunswick, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.

The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.

Appeal Planned

J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.

“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.

J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.

“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.

NJ Verdict

Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.

Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.

In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was def


Updated April 24, 2014

WOMAN WITH SURGICAL MESH STILL SUFFERING, YEARS AFTER SURGERY  (Video)  

FiDA Highlights

by JANET ST. JAMES

WFAA TV  Dallas, TX

Posted on April 24, 2014 at 10:37 PM

Updated yesterday at 10:43 PM

DALLAS — It's not just walking that's painful for 64-year-old Linda Batiste. Life, in general, is a physical struggle.

"I have pelvic pain," she said through tears. "It actually does feel like a scouring pad in your body. You can feel in your women parts, what it is. It's there."

The condition that brought Batiste to tears is embarrassing for her discuss. That feeling comes from a product left inside her body to fix urinary incontinence.

More than 20-million women in the United States suffer from urinary incontinence and/or pelvic prolapse. In thousands of cases — including Batiste's — doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.

But what Batiste got from her 2011 procedure was not relief.

"I have never been pain-free since then,” she said.

Surgical mesh is a synthetic material manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse, and hernia operations.

Attorney Tim Goss, a parner at the Dallas law firm Freese & Goss, represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon. It was the first mesh cast to go before a Texas jury.

"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes, and it has particle loss,” he said. “And all of those problems cause other problems — like scarring, chronic pain, for example."

The American Urogynecologic Society says mesh is "safe, effective, and has improved the quality of life for millions..."

Three years ago, Hal Samples described the side-effects of his mesh hernia surgery as "torture."

"It can be a bend-over pain, where it will be a sharp stab," he said.

Samples was forced to travel out of state for surgery to remove the mesh. The procedure was not a complete success, and Samples continues to have some pain, even now.

The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices."

In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare" and that mesh "may expose patients to greater risk" than traditional procedures.

Since then, women across the country have formed organizations and online support groups trying to get mesh removed from the market.

Linda Batiste won a $1.2 million judgment against the maker of her mesh, Ethicon.

"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product,” said Goss, who represents 9,000 mesh cases.

Goss said the lawsuits have the potential to become the largest mass-tort in history — bigger than the Phen-Fen diet drug mess.

A statement from Ethicon spokesman Matthew Johnson called the Dallas verdict mixed:

"A jury in the 95th Judicial District Court of Dallas County, Texas, returned a mixed verdict today in a product liability trial concerning Ethicon’s TVT-O pelvic mesh, which is used as a minimally invasive treatment for women suffering from stress urinary incontinence (SUI).

"The jury found Ethicon properly informed of the known risks associated with TVT-O. The jury also found that the product was defectively designed. The jury awarded $1,200,000 in compensatory damages. The jury declined to award punitive damages.

“We believe the evidence showed Ethicon’s TVT-O pelvic mesh was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal.

“We empathize with all women suffering from SUI, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events,” Johnson continued. “TVT-O has been deemed safe and effective by regulators and practitioners alike, and it continues to be an important option for treating physicians to offer to women suffering from SUI.”

In the meantime, Linda Batiste has had several surgeries to try to remove the mesh, which is embedded in her tissue. Her original problem of incontinence is back.

"And it's compounded the pain that I normally would have had,” she said. “I never wish for any other woman to feel this way or to have it happen to them."

E-mail jstjames@wfaa.com

Texas woman first in bellwether surgical mesh trial.

Read the ruling here.
NewJersey.com ruling article here.


http://www.charlestondailymail.com/policebrfs/201402120147

Wednesday February 12, 2014

Trial against pelvic mesh manufacturers ongoing

by Andrea Lannom

Daily Mail Staff

CHARLESTON, W.Va. -- A Johnson & Johnson president of North American businesses was the latest to testify in one of several cases against the manufacturers of pelvic mesh.

Trial began Monday in the case brought by women who say the mesh used to treat stress urinary incontinence led to pain and permanent injury because of its defective design.

Carolyn Lewis, Kenneth Lewis, Augistina Brown-Singletary, Andre Singletary-Smith, Karin Harrison, Robert Harrison, Patricia Headrick, Darrell Headrick, Katie Uszler, Nick Uszler, Kelly Young and Kenneth Young originally filed the lawsuit in July 2012 in the Northern District of Texas.

Lewis received surgery in 2009, where doctors implanted the TVT, or transvaginal tape. The lawsuit alleges because of the defective design of the product, Lewis experienced pain when she emptied her bladder and during sex.

Defendants in the case are Johnson & Johnson, Ethicon Inc., Ethicon Women's Health and Urology, Gynecare and American Medical Systems Inc. This is the first case against Ethicon.

Attorneys for the companies said the plaintiffs never complained about problems from the mesh until after they filed the lawsuit and said the product was not defective.

U.S. District Judge Joseph Goodwin is overseeing the consolidation of more than 26,000 similar cases alleging injury from plastic mesh devices used to treat bladder and other organ weaknesses.

Laura Angelini, who has served in several marketing positions at Johnson & Johnson and Ethicon, appeared in a pre-recorded video deposition.

In her video testimony, Angelini agreed with the attorney, saying a Swedish company and the inventor of the TVT signed an agreement that later led to the company being the exclusive supplier of the tape. She said the inventor was a 20 percent shareholder in the company.

Angelini said the TVT initially was launched in Europe and was launched in the U.S. in late 1998. She agreed the type of mesh was used in hernia repair.

In Monday's opening statements, Lewis' attorney, Thomas Cartmell, alleged Ethicon used mesh to treat hernias but problems caused by the heavy nature of the product and small pores required surgeries to remove it.

Cartmell said a Swedish inventor later contacted Ethicon saying he used the old mesh to treat stress urinary incontinence and experienced no complications.

In her video testimony, Angelini said the Swedish company and the inventor signed an agreement where his company would be the exclusive supplier of the TVT.

Under the agreement, Agenlini agreed Johnson & Johnson would pay $400,000 to the company if it received acceptable clinical trial results.

In her opening statements, Christy Jones, an attorney representing the mesh manufacturers, said there were several studies on the transvaginal tape, not just those conducted by the inventor.

She said those studies have shown the tape is effective to treat stress urinary incontinence and said it was deemed the gold standard to treat this condition.

In the video, the attorney read off the agreement, saying Johnson & Johnson would pay $20 million for the TVT and a second installment of $2 million. If 140,000 units of TVT were sold, then Johnson & Johnson would pay another $2 million to the seller.

Angelini agreed that if all payments were made, that would total more than $24 million for the TVT device.

The video also showed an email from Angelini in response to her colleagues in the U.S. The attorney asked if she wrote they should spin it to more of a safety aspect than the complications and asked if she had influenced the title of a medical presentation.

Angelini responded that she provided her perspective to provide a more balanced position to show the safety data they had.

Goodwin dismissed the jury early Wednesday and told them to come back at 9 a.m. today. According to the court calendar, the trial is scheduled to last through Feb. 25.

Contact writer Andrea Lannom at Andrea.Lan...@dailymailwv.com or 304-348-5148. Follow her at www.twitter.com/AndreaLannom.