J&J Accused of Criminal Behavior: Pelvic Surgical Mesh

Protest Targets J&J CEO on Day of Annual Shareholder Meeting

Women Allegedly Harmed by Pelvic Mesh Express Disappointment with J&J

ARTICLE | MAY 11, 2017 - 9:48PM | BY DAVE SCHATZ   FiDA highlight

MAM co-founder Lisa Mason is seen here during a rally on April 27 outside the State Theatre. Mesh Awareness Movement

NEW BRUNSWICK, NJ–Members of  the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement.

The group, a grassroots effort to bring awareness to the harmful effects of mesh on the human body, held a rally against J&J in New Brunswick on April 27, during its annual meeting of shareholders. 

MAM has a Facebook group that's grown from about 20 to 700 people in just a year-and-a-half, according to co-founder Tammy Jackson, who said others have contacted her but aren't keen on taking part in social media due to their attorneys' advice.

Jackson said a couple woman in the group were recently offered $189 by the pharma giant to settle their cases, but declined, while five others she knows personally accepted $4,000, and seven received $200,000, in the past six to seven months.

“It’s hard to get people so badly injured to travel across the country and stand all day,” said Jackson, a 50-year-old resident of Kentucky, and former nurse, adding she also brought chairs to the rally for some of the women.

Yet during the hour-plus meeting of shareholders inside the State Theatre, where audio was streamed live on the internet, the women held a protest outside the theatre and say they feel their voices were heard.

Their chants included:

• “No more mesh…”
• “Stop the harm, No more profits.”
• “You are not going to be able to hide from us.”
• “Profit over lives.”

Jackson has had 17 mesh removal and reconstruction surgeries over the past four years, she said.

“Trying to remove mesh out of your pelvic is like removing rebar out of concrete," said Jackson. "Your bladder is angry."

J&J says "we are nothing more than a 'cost of doing business.' We say, we are a hundred thousand severely and permanently injured people who could just as easily be your wife, mother or sister," continues MAM’s statement.

"It doesn’t matter to [J&J] that they’ll have to spend, for example, $2.5 Billion in Litigation, Verdicts, Penalties and fines because they’ve already made $25.1 Billion,” added the statement.

Jackson’s 10-year-old daughter was interviewed for a documentary about patient safety while in the Garden State with her mother and father for the rally.

She told the producers, “I would say quit making mesh and help my mommy,” according to Jackson, who said many MAM members were also interviewed for the film. 

“Where's the media?” wondered one MAM member during the rally. “They need to tape this -- we should flood the TV stations.”

One journalist, Jane Akre, operates the Mesh Medical Device News Desk (MMDND), and was present for J&J's annual meeting of shareholders on the morning of April 27. 

She thought the presentation to J&J's stock holders was "rehearsed" and highlighted "the health of J&J's stock," as Alex Gorsky, J&J's chief executive officer, repeated the words "sustainable" or "people come first." 

Yet across the street, she writes, via an "orderly, heart-felt display," some 30 women and their families rallied.

But their signs indicated they didn't feel like they came first: “The Johnson & Johnson Credo: ‘Research must be carried on, innovative programs developed and mistakes paid for.' Pay the mesh injured for your mistake!”

“Mr. Alex Gorsky” was targeted by another sign that continued, “The highest form of ignorance is when you reject that which you know nothing about.”

A sign urged Gorsky to “Talk to the mesh injured,” while the message on another read: “#SerialKiller CEO. It’s time for you to go!”

"Each [woman] represents at least 10,000 [pelvic] mesh implanted women who can’t make it to a mesh rally, because they are too sick or broke from fighting to regain their health! And that doesn’t even begin to include the one million hernia mesh implants a year!” wrote Akre.

"All use polypropylene! Some day in the not so distant future, we may come to recognize that this cheap plastic is not an ideal, bio-compatible material for an implant, I believe."

"The legal facts have shown that [J&J] knew these mesh devices were unsafe, but they quickly put them on the market anyway... bypassing proper FDA approval, failing to conduct thorough testing and withholding serious risks and warnings,” continues MAM’s statement.

"Little did I know that [during the shareholders meeting], a Philadelphia jury was delivering the third verdict for a plaintiff in another mesh trial – $20 million, which included $17.5 million in punitive damages!"

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

Akre wondered whether J&J might now be considering a "multi-billion dollar global settlement" and whether "fighting mesh-injured women in court" is worth it. 

The pharma giant is facing $34.5 million in punitive damages, plus other amounts awarded by juries in three separate mesh trials in Philadelphia state court, according to reports.

Akre noted that after half a decade of writing reports for MMDND, media coverage of mesh issues is gaining  some traction.

"Internationally, the media is less afraid to report of Pharmaceutical Giants," she writes citing front page stories in Scotland, Australia, New Zealand and the UK, for instance.

Though Akre provided coverage of the April 27 MAM rally, she said very few reporters were there.

“It was a powerful day," said one woman who took part in the event.

"J&J had a line of buses on the other side of the street to block the view of the rally. [The company] rented those buses with money they earned from harming us,” she added, saying that she felt like J&J owned New Brunswick.

J&J did not respond to a request for comment. 

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

BREAKING NEWS! MDND reports $100M verdict

Jury Awards Plaintiff $100 Million in Boston Scientific Pelvic Mesh Trial

May 28th, 2015 | By Jane Akre (FiDA highlight)

$100 million in damages.

That is the amount a Delaware jury today awarded to mesh injured woman Deborah Barba. The amount includes $25 million in compensatory and $75 million in punitive damages, established to send a message to the company.

The 51-year-old from Newark, Delaware, sued manufacturer Boston Scientific for her permanent and serious injuries caused by the company’s Advantage Fit and Pinnacle transvaginal meshes.  She was implanted in 2009 and has suffered significant complications and endured two surgeries that did not fully remove the devices.

“While we are extremely pleased with this verdict and the relief we hope it will bring to the Barbas for Deborah’s unspeakable suffering, we also hope Boston Scientific and other mesh manufacturers take note of this verdict and resolve all pending cases swiftly. Deborah’s case will hopefully bring more awareness of mesh issues,s however, no woman and her loved ones should have to endure the stress of going to trial and baring their souls publicly to achieve justice,” said Barba’s attorney Fidelma Fitzpatrick of the Motley Rice law firm.

The jury found Boston Scientific was negligent in its design and manufacture of the Pinnacle and Advantage Fit devices and that the warnings were insufficient to unsuspecting doctors and their patients.

“I am thankful for the jury’s verdict and hope my story can help other women who are suffering from mesh complications to receive the resolution they deserve,” said Deborah Barba. “While difficult to share, I hope my case demonstrates to all mesh manufacturers the dangers of their products and the justice they owe victims.”

The case is Deborah Barba v. Boston Scientific Corporation, Superior Court of the State of Delaware in and for New Castle County, C.A. No. N11C-08-050 MMJ.

http://meshmedicaldevicenewsdesk.com/jury-awards-plaintiff-100-million-in-boston-scientific-pelvic-mesh-trial#comment-519041
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Boston Scientific Told to Pay $100 Million Over Mesh

Jeff Feeley, May 28, 2015  (FiDA highlight)

Boston Scientific Corp. must pay $100 million to a Delaware woman who blamed the company’s vaginal-mesh inserts for leaving her in constant pain and unable to have sex, in the first verdict after the company agreed to begin settling cases over the devices, and the biggest yet.

A state-court jury in Delaware found Thursday that Boston Scientific’s Pinnacle and Advantage Fit inserts, built to buttress sagging organs and treat incontinence in women, were defectively designed and company executives hid the flaws from Deborah Barba.

The 51-year-old former bank teller contends the inserts eroded once they were implanted, leaving her with a scarred vagina and a host of medical problems. The verdict is the largest so far against Boston Scientific over its vaginal-mesh inserts. It eclipsed a $73 million award last year to a Texas woman who blamed the company’s Obtryx sling for her injuries.

The jury also found Boston Scientific engaged in fraud by failing to alert doctors to the devices’ faulty design. It awarded $25 million in compensatory damages and hit the company with a $75 million punitive-damages award.

The vaginal-mesh verdict is also the first since Marlborough, Massachusetts-based Boston Scientific agreed last month to pay $119 million to resolve about 3,000 lawsuits over the devices in the first settlements of claims the inserts damaged women’s organs and made sexual intercourse painful.

Appeal Planned

Kelly Leadem, a Boston Scientific spokeswoman, said the company disputes the conclusion that the inserts were flawed and caused Barba’s injuries.

“We disagree with the jury’s finding and intend to appeal based on the strength of our evidence,” she said in an e-mail.

The verdict is surprising because it came in Delaware, the most corporate-friendly state in the nation, Erik Gordon, a professor at the University of Michigan’s business and law schools who teaches classes on how drugs and medical devices are developed and regulated, said by e-mail.

“Corporation-friendly Delaware juries rarely award punitive damages,” Gordon said. “A good portion of Delaware’s economy is driven by its business of domiciling most of the country’s largest corporations.”

Delaware, the corporate home to more than half of the U.S.’s publicly traded companies and 63 percent of Fortune 500 firms, had more than 1 million legal entities incorporated in the 900,000-resident state by 2012, officials said.

‘Loudly, Clearly’

“The jury spoke loudly and clearly that Boston Scientific’s defective devices injured Mrs. Barba and many other women and they should step and take responsibility for causing that harm,” said Fred Thompson, one of her lawyers.

The U.S. Food and Drug Administration ordered Boston Scientific, Johnson & Johnson and more than 30 other vaginal-implant makers in 2012 to study rates of organ damage and complications linked to the devices after the companies faced a wave of lawsuits over them.

Women such as Barba allege that inserts produced by Boston Scientific and other companies are made of substandard materials and shrink once they are implanted, causing organ damage and persistent pain. J&J moved in June 2012 to pull four lines of inserts off the market.

Many of the more than 70,000 mesh-insert cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Others have been filed in state courts in Delaware, New Jersey, Missouri, Texas and California.

Goodwin has been pushing manufacturers to consider settling the cases before they face billions in jury awards.

Settlement Talks

Boston Scientific, C.R. Bard Inc. and other makers of vaginal inserts had talks two years ago about creating a global settlement of cases over the devices, according to people familiar with the discussions. J&J, which refused to participate in 2013 settlement talks, has now begun to settle some cases.

While Boston Scientific and Bard couldn’t agree on an overarching settlement program, both companies have begun to settle some individual suits and some lawyers’ inventories of cases.

Boston Scientific agreed to pay the $119 million to resolve nearly 3,000 cases collected by a group of plaintiffs’ lawyers led by Houston litigator David Matthews in April. The settlement provided an average payout of about $40,000 per case.

The Delaware case is Barba v. Boston Scientific Corp., CA No. 11C-08-050-MMJ, Superior Court of Delaware (Wilmington).

http://www.bloomberg.com/news/articles/2015-05-28/boston-scientific-ordered-to-pay-100-million-over-vaginal-mesh

Giant J&J quietly moves/'streamlines' annual meeting.

Johnson & Johnson Quietly Switches Venues, Shortens 2015 Shareholders Meeting

Brunswick-Based Pharmaceutical Company: "We Have Adjusted the Format of This Meeting to Better Align With Current Industry Practices"

ARTICLE | APRIL 14, 2015 - 11:30AM | BY DAVE SCHATZ

NEW BRUNSWICK, NJ–For the first time since April 26, 1989, Johnson & Johnson's annual shareholders meeting will be held at the historic State Theatre in New Brunswick.

After frequent protests at previous shareholder meetings, the consumer products giant has quietly moved the big meeting, coming up on April 23 at 10 a.m., from its usual location, the Hyatt Regency Hotel, and has significantly shortened the meeting to one hour.

Previous meetings included a free lunch and gift bag for all in attendance, but that won't be the case this year.

“We are pleased to be hosting the 2015 Annual Meeting at The State Theatre of New Jersey. Johnson & Johnson is a long-time supporter of this wonderful space, and it has hosted our Annual Shareholders Meeting in the past,” said a J&J spokeswoman.

J&J said they've adjusted the format of the upcoming meeting “to better align with current industry practices.” It will be webcast live, and also available for replay following the meeting. 

But the running time of the meeting is scheduled for only one-hour, while 2014's ran for at least an hour and one-half. According to J&J it will include the formal completion of items of business for the year, a brief update from Chairman/CEO Alex Gorsky, and an open question and answer session.

“The agenda for the meeting remains essentially unchanged, but the business highlights presentation has been streamlined,” J&J told NB Today.

“We conducted a benchmarking study of our peer companies to understand best practices for these meetings and have adjusted our program to align with those standards.”

A group of five individuals who were injured by one of J&J's products flew to NJ at their own cost and visited the Hub City to protest the mesh implants and request an internal investigation over the shredding of papers, at last year’s annual shareholders meeting.

The group held a news conference on the public sidewalk where many shareholders saw the demonstration.

Last year, police constructed a fire and set off an explosion after the meeting was over.

“It was exploded after everything was over, like they didn't need it anymore,” said journalist Jane Akre, who gathered the group for the trip to New Brunswick. She added that she thought setting up the explosion was “overreaction.”

“You have to believe they were surprised by our visit last year,” Akre told NB Today.

“They brought in the state troopers and angry German Shepherds and even had an explosion designed to designate as a diversion if necessary.”

J&J will report financial ratios in today's First Quarter Earnings Call, which will also be available as a Webcast. Its shares fell 1.5 percent to $100.55 yesterday.

“Investors and other interested parties may access the live audio webcast of the [annual shareholders] meeting by visiting the Company's website at www.jnj.com and clicking on the webcast icon,” reads a release.

http://newbrunswicktoday.com/article/johnson-johnson-quietly-switches-venues-shortens-2015-shareholder-meeting

About the Author

Dave Schatz

Reporter

Dave Schatz covers mostly business, but also enjoys sports reporting.

You can contact him at dschatz@newbrunswicktoday.com or @dave_schatz on Twitter.

Surgical Mesh Harmed Patients call on Attorney General: Dangerous Product

Injured Women Call on WashingtonAttorney General to Investigate

Posted: Monday, June 9, 2014 12:33 pm

Injured Women Call on Washington Attorney General to Investigate

Johnson & Johnson:

Washington Women Cite Injuries and Public Health Care Costs in Letter to AG Ferguson

Olympia, WA – Washington women who have been seriously injured by pelvic mesh implants asked Washington Attorney General Bob Ferguson to investigate Johnson & Johnson for its dangerous pelvic mesh implants, citing their personal health problems and costs incurred by Washington taxpayers.

“We ask that Attorney General Ferguson investigate Johnson & Johnson and its CEO Alex Gorsky for selling dangerous products to women throughout the state of Washington. The damage this product has caused already has cost taxpayers too much money through Medicaid and other state public health systems,” stated Jane Akre, who has been organizing survivors of pelvic mesh implants for more than five years.

“Across Washington, women are being hurt by Johnson & Johnson’s dangerous products, and the company’s top executive, CEO Alex Gorsky, needs to be held accountable for the women he has hurt,” added Akre. “Pelvic mesh implants are perhaps the most dangerous product to women’s health on the market today. Gorsky should immediately take this dangerous pelvic mesh product off the market.”

More than 70,000 separate lawsuits have been filed against manufacturers of pelvic mesh implants. Local survivors in Washington signed onto today’s request for an investigation.

"Johnson & Johnson should be investigated because too many have suffered too long, and they need to bring a stop to it,” stated survivor Danyelle Robinson of Washington. “Something has to be done to assure there are substantial penalties."

See the letter to Attorney General Ferguson directly below.

# # #

June 9, 2014

By Facsimile: 206-587-5636

The Honorable Bob Ferguson

Attorney General

Washington State Office of the Attorney General

1125 Washington Street SE

PO Box 40100

Olympia, WA 98504-0100

Dear Attorney General Ferguson,

As survivors of pelvic mesh implants and Washington taxpayers, we request that your office immediately begin investigating whether Johnson and Johnson should be held liable for expenses incurred by the state as a result of dangerous and defective pelvic implants.

Johnson and Johnson is the largest producer of pelvic mesh implants in the world. This product is creating a health crisis among women across the state of Washington, which in turn is resulting in significant costs to the states' public health systems.

Specifically, we ask for you to investigate Johnson and Johnson and its Chairman Alex Gorsky for possible violation of section 19.86.20 of the Revised Code of Washington for deceptive and fraudulent business for their knowledge of the danger of the mesh implants and the public health systems’ costs to the taxpayers of Washington.

This request follows the recent revelation by a West Virginia court that Johnson and Johnson destroyed numerous documents relevant to lawsuits filed against the company by thousands of women across the United States who have been seriously injured by the company’s pelvic mesh implants.[1]

It is critical that the Washington State Office of the Attorney General pursue this matter to recoup the state taxpayer dollars Medicaid and other public health systems have been and will be forced to spend to treat women who have been injured. Action by the state attorney general will also demonstrate that a major U.S. corporation should not destroy evidence in judicial proceedings. The destruction of this evidence undermines the ability of Washington women who have been hurt by Johnson & Johnson to receive justice.

Background

In the last few years, medical device manufacturers including Johnson & Johnson have come under fire for marketing dangerous medical devices, drugs and other consumer products, often without receiving proper regulatory approval. Many of these companies, including Johnson & Johnson, have paid billions of dollars in fines in litigation and settlement costs and made repeated pledges of reform, yet continue to display an indifferent attitude toward the harm they have caused as well as a willingness to evade the law.

Currently, Johnson & Johnson faces thousands of product liability lawsuits relating to the company’s pelvic mesh implants, marketed most commonly as treatment for pelvic organ prolapse and stress urinary incontinence. There are estimated to be hundreds of thousands of women that have been – and continue to be - implanted with these dangerous products. Women have suffered severe pain and injuries due to ineffective and dangerous implants.

Investigations into the pelvic mesh products produced by several companies, including Johnson & Johnson, date back to before October 20, 2008, when the FDA first issued a Public Health Notification.[2]

Beginning in March 2005, Johnson & Johnson sold one of its most popular devices, the Gynecare Prolift, without alerting the Food and Drug Administration for three years. When the FDA was made aware of the Prolift device, the agency informed Johnson & Johnson that the device required government approval.[3] In May 2008, the Prolift was cleared for sale under the 510(k) process under the claim of “substantial equivalence” to devices already on the market. It had never been rigorously tested nor demonstrated effective in clinical trials.[4]

Further indicating Johnson & Johnson knew how harmful pelvic mesh implants were but nevertheless continued marketing the defective product to unsuspecting women, the company destroyed thousands of documents regarding the implants. Although top company executives initially denied it, a magistrate judge found that Ethicon, a wholly owned subsidiary of Johnson & Johnson that manufactured the implants, destroyed documents pertaining to their effectiveness and safety as far back as 2007.[5] Alex Gorsky, the current Chairman and CEO of Johnson & Johnson, was named head of Ethicon in 2008, before most of the documents were destroyed, and has continued to oversee it in his climb through the company’s ranks.[6]

Apparent Violation of Law

Johnson and Johnson and its CEO Alex Gorsky may be in violation of section 19.86.20 of the Revised Code of Washington for unfair or deceptive business practices concerning both his corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction.

The Washington State Office of the Attorney General has the authority to conduct a comprehensive and thorough investigation into whether Johnson & Johnson, in the course of advertising, soliciting, selling, promoting and distributing pelvic mesh implants, has engaged in a course of trade or commerce that constitutes unfair or deceptive acts or practices, and is therefore unlawful under the Washington consumer protection laws by misrepresenting the safety of pelvic mesh implants.

The fact that Johnson & Johnson has offices and conducts business throughout Washington only adds to the importance of your office pursuing this matter.

Johnson & Johnson also may have violated Washington Case Law pertaining to destroying physical evidence in an official proceeding.[7] In Pier 67, Inc. v. King County, the Court held “where relevant evidence which would properly be a part of a case is within the control of a party whose interests it would naturally be to produce it and he fails to do so, without satisfactory explanation, the only inference which the finder of fact may draw is that such evidence would be unfavorable to him.”[8] Culpability turns on whether the party acted in bad faith or whether there is an innocent explanation for the destruction.[9]

After initial denials by top executives, it is now clear that Johnson & Johnson destroyed thousands of documents related to Ethicon’s development and marketing of pelvic mesh implants.[10]

Johnson & Johnson is one of the world’s largest corporations whose products are used not only by women but also children and men. This investigation is urgently needed as the lives and safety of so many women in Washington and across the United States depend on it.

Please do not hesitate to contact us if we can provide any further information. Thank you for your consideration.

Sincerely,

Patricia Buchanan – Seattle, WA

Danyelle Robinson – Spokane, WA

Mary Wakefield – Colbert, WA

Elizabeth Weber – Spokane, WA

Surgical mesh and medical destitution: a medical device failure.

A tangled web: Lakewood woman creates a nonprofit towarn others about medical mesh

1

26 May 2014

by Brittany Nunn

Photo by Hal Samples

Lakewood neighbor Aaron Horton just wants her mom back.

It’s the little things — like going out for sushi, window-shopping, getting facials or manicures, and chatting about art — that Horton misses the most.

“I miss my mom,” Horton says. “I miss being able to pick up the phone and say, ‘Hey, I just saw this purse and it made me think about you,’ or ‘I just saw this movie; let me tell you about it.’ ”

Although Horton’s mom is still alive, in many ways Horton has been forced to prematurely grieve the loss of the mother she once had.

Horton’s mom, who asked that we not reveal her identity, is in a constant state of excruciating pain — at times worse than anything she experienced during childbirth — due to an injury caused by a medical device called trans-vaginal mesh.

The pain wasn’t always so extreme.

Originally, Horton’s mother suffered from urinary incontinence (the loss of bladder control) and pelvic organ prolapse (a condition in which the bladder and the bowels slip out through the vaginal canal). To fix the problem, doctors used trans-vaginal mesh, which essentially is a small hammock made of plastic mesh, to hold her organs in place.

She was told the operation would be minimally invasive, but she knew something was wrong as soon as she woke up from the surgery. Her surgeon told her she simply needed time to heal.

The pain was localized at first, occurring only in her pelvic region, but it was unrelenting. For months, doctors dismissed the pain. Eventually it began to spread to every part of her body — sometimes it was sharp, sometimes it was dull, sometimes it was throbbing, and sometimes it was all three. She talked with more doctors, but no one could give her any answers. She tried physical therapy and nerve blocks, but nothing helped.

“My mom was really sick, and she wasn’t getting better,” Horton says.

“Once I realized how sick she was, I got online to see if there were other people, and I realized there’s this whole community of women who have been injured by this medical device.”

Horton wrote what she calls “a hearticle” about her experience of watching her mom suffer and not being able to help, and it was published on journalist Jane Akre’s website, Mesh Medical Device News Desk, in July 2013. Horton received an outpouring of support in the comments section.

“They had all gone through the same thing and had the same questions,” she explains. “I thought I was going to get some help, and then it just kind of confirmed that there was no help available.”

It spurred Horton to dig deeper, to find some answers for her mom, as well as for the many other suffering women.

She discovered that doctors have used medical mesh in more than 1.5 million women to fix organ prolapse, urinary incontinence or hernia, and they continue to implant it in some 70,000 to 90,000 women every year.

Most of the women are post-menopausal baby boomers who have had children.

Although many women are happy with the implant, thousands report suffering due to injury caused by the device.

Horton formed a nonprofit called The Mesh Warrior Foundation For the Injured, which she operates from her Lakewood home. She works full-time doing research, talking with doctors and surgeons, raising awareness about the mesh-related injuries, and advocating for the injured.

What Horton found during her research shocked her.

There are six manufacturers of the product, and the largest one is Johnson & Johnson, through the medical unit of its company, Ethicon.

Medical mesh is made of propylene plastic, and it was originally used for hernia repair. Then, in early 2000, manufacturers began creating other mesh products, which Horton says were never tested on live humans, only cadavers and dogs.

The U.S. Food and Drug Administration (FDA) approves the products through the 510(k) process, which “clears the device for commercial distribution” without having to go through the entire process, according to the FDA website.

Instead, manufacturers simply have to prove the new product is “at least as safe and effective” as a predicate device of substantial equivalence (SE) that has already been approved by the FDA.

As soon as the FDA rubber-stamps the device, manufacturers are free to start marketing it. Although there are other ways to fix medical issues such as incontinence or pelvic organ prolapse, most of the alternative methods are considered invasive, complicated and expensive. Mesh was marketed as simple and cheap, and the general public became the test subjects, Horton says.

The FDA in 2008 issued a Public Health Notification regarding “serious complications associated with trans-vaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

The notice states, “The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”

“My question was: How did this happen to 1.5 million women?” Horton asks. “All the safeguards we have in our society, and we’re supposed to have the best health care in the world and the best access to it.”

Dr. Michael Hibner, the director of the division of surgery and pelvic pain at St. Joseph’s Hospital and Medical Center in Phoenix, has been removing the mesh from women’s bodies for several years.

“I think it’s a very small percentage [of women] that have a serious reaction,” he says. “There are people who are happy with the mesh. The problem is that those who are unhappy with it are really, really unhappy with it.”

Most of the women Hibner sees have pain due to three things: pain from the mesh rubbing against or tugging at the nerves, nerve damage during implant or explant of the mesh and/or a foreign-body reaction to the mesh itself.

Hibner believes manufacturers are largely to blame for the mesh-related injuries.

Hibner says that if the procedure is done right, women shouldn’t have pain or discomfort. The problem, Hibner says, is that manufacturers are selling the device to doctors as a one-size-fits-all device, and it’s being touted as a simple, non-invasive procedure, so the doctors implanting the mesh haven’t been appropriately prepared or trained.

Dr. Greg Vigna, who spent 18 years in the medial industry but now practices law in catastrophic injury in California, is familiar with the trail of broken lives mesh-related injuries leaves behind.
As a doctor, Vigna worked with patients who suffered from pudendal neuralgia, which is chronic pain due to the pudendal nerve, which is located in the pelvis, being entrapped or compressed. Until a few years ago, this was very uncommon.

“This mesh device caused a problem that used to be very rare,” he says. “It’s not rare anymore because mesh has been used so many times.”

Most women do not have the time, resources or the physical wellness needed to go head-to-head with pharmaceutical companies, so they become “medically destitute,” Vigna says. They lose their jobs because they can’t work, they lose their husbands because they can’t have sex, and they lose their families because they’re in so much pain they can’t function normally.

“There’s failure in the medical community, there’s failure in the financial community, and there’s failure in the legal community,” Vigna insists.

At the time of publication there had been 56,999 mesh-related lawsuits filed, according to Vigna, but very few settlements have come down.

At the same time doctors like Hibner are taking the mesh out, hundreds more continue to put it in. Other doctors try to remove mesh, but very few know how to do it correctly, Vigna says.

“For years women were only getting part of the mesh taken out, and that wasn’t helping,” Vigna says. “In fact, that was just making things more complicated for future doctors.”

Most of the women Hibner sees have already had the device extracted but are still experiencing pain, usually because parts of the mesh are still inside the body, pulling at sensitive nerves. He says he believes removing the entire device, all at once, is best.

“I’ve seen women who have clearly gotten better after removing the mesh. But then, there are other ones who didn’t. So I think it depends on the patient. Some have had more injury to the nerves, and others have had less injury to the nerves, so it’s hard to tell.”

Horton and her family are crossing their fingers, hoping Horton’s mother is one of the lucky ones.

Horton’s mother had surgery to have her mesh removed in May, and her family is still waiting to find out if the surgery was successful in lessening or erasing her pain.

“But the truth is, each injury is different,” Horton says. “They don’t know what happens during the explant because it just depends on the woman’s body and the kind of injury.”

In the meantime, Horton continues to research and fill her blog with personal stories and interviews with doctors in hopes of reaching as many women as possible.

“There’s still so many more who don’t know,” Horton says. “That’s what keeps me awake at night.”

To learn more  about Aaron Horton and The Mesh Warrior, visit themeshwarrior.com

- See more at: http://lakewood.advocatemag.com/2014/05/26/medical-mesh-tangled-web/#sthash.m0XaEEZh.dpuf


Comment - FiDA  (retrieve this)
Thank you for this excellent article, Brittany Nunn and Lakewood/East Dallas Advocate!  My advocacy to demand safer and more effective implanted medical devices began 5 years ago when a family member began suffering with a failed implanted device.  What I learned chills me to the bone in the middle of a Dallas summer:  the system is rigged!  Medical device companies have so much clout that our FDA is a mere mirage and there is no "there" there.  Patients are not protected and even the judicial system has been altered to favor the industry and protect the profiteers from accountability.  The mounting patient harm signals "settlements" that do little to stop the carnage.  I blog at Failed Implant Device Alliance and attended FDA Patient Representative training (by invitation).

Implanted Surgical Mesh Survivors Fight Back at J&J Annual Shareholders Meeting

Survivors Of Johnson &Johnson (JNJ)Defective Pelvic Mesh Implants To Urge U.S. Senate To Launch Investigation

4/23/2014 2:00:19 PM

 NEW BRUNSWICK, NJ – On Wednesday, 11am EST, survivors living with chronic injuries resulting from defective Johnson & Johnson (J&J) pelvic mesh implants will field questions from members of the press about their intentions to have their voices heard during J&J’s Annual Shareholders Meeting which will take place at 10am EST at the Hyatt Regency, New Brunswick (2 Albany St., NJ 08901).

WHO: Survivors & Family Members: Gay Courter, Robert Fish McClenny, Linda Wilcox, Estelle Tasz, Teresa Sawyer Advocates: Levana Layendecker (CAN), Jane Akre

WHAT: Press Conference call with survivors living with chronic injuries stemming from J&J pelvic mesh implants and their advocates.

WHEN: Wednesday, April 23, 2014 at 11 am EST

DIAL-IN INFO: 866-952-7535; *Conference ID: MESH

The survivors will file a grievance Wednesday morning with Senator Kay Hagen, Chairwoman to the Subcommittee on Children and Families, calling on the Subcommittee to investigate J&J’s recent destruction of documentary evidence related to multi-district litigation filed by over 20,000 women severely injured by the corporations pelvic mesh devices. The call for a senate investigation comes on the heels of an announcement made by the DOJ that they are reviewing a similar request and it will be paired with a call made by the survivors that J&J’s board of directors conduct an internal investigation in the interim.

During the press call the survivors, accompanied by members of The Corporate Action Network (CAN) will detail their 48-hour plan of action, which will include:

• A visually arresting light projection protest action targeting J&J (scheduled for 8pm 4/23 [Corner of Church St & Neilson St, New Brunswick NJ 08901]).

• Explosive video content released on johnsonandjohnsonhurtswomen.com

• A press conference outside J&J’s AGM (scheduled for 8am, 4/24 outside the Hyatt Regency [2 Albany St, New Brunswick, NJ 08901]).

• Mesh survivors plan to speak inside the J&J AGM itself (scheduled for 10am, 4/24 inside the Hyatt Regency [2 Albany St, New Brunswick, NJ 08901]).

About Gay Courter

Gay Courter, 69, of Crystal River, Florida is a bestselling writer and documentary filmmaker. She had mesh implanted during a hysterectomy, in case of aging problem, but not needed at the time. Her mesh eroded causing pain, severe infection, and urinary problems. She had a removal but continues to have ongoing issues.

About Robert Fish McClenny

Robert Fish of McClenny, Florida watched his mother in pain after implantation of the Bard mesh sling and the Johnson & Johnson Prolift. His mother Wilma Darlene Fish, 68, was referred to pain management but ended her own life in October 2011 before she could make it to the clinic to receive narcotics. He does not want her life and suffering to be in vain and promises to help fight the implantation of surgical mesh without the properly testing.

About Linda Wilcox

Linda Wilcox, 67, of Bluffton, South Carolina had a Prolift mesh kit implanted in February 2011. Prior to her implant she had a full live and was involved in real estate investment research and the arts. Today she lives in chronic pain which leaves her unable to concentrate. She stays home most of the time. Ms. Wilcox has endured two partial removals and has more surgery ahead though she’s been told the damage is permanent.

About Estelle Tasz

Estelle Tasz, 37, is the mother of four daughters. When was 29 following the birth of her youngest she was implanted with Johnson and Johnson Prolift mesh kit to treat prolapse. In the 9 years since then she’s had 12 surgeries including a major 13-hour surgery to remove the mesh which had eroded into 3 organs and migrated up into her abdominal wall. She is facing her next surgery in May 2014 to remove additional mesh and reconstruct her pelvic floor. She’s been diagnosed with a rare autoimmune disease since her mesh implant which is attacking her heart.

About Teresa Sawyer

Teresa Sawyer, 45, had a Johnson & Johnson TVT mesh implanted during surgery to remove a cyst. She did not know the risks associated with the use of mesh as she was told by her doctor it was the “Gold Standard” and “completely safe.” Within 30 days the mesh started eroding in her body and she decided she wanted the plastic device removed. That has not proven to be as easy and Teresa has undergone mesh explants surgeries and suffers from bladder infections and severe pain. Because of her experience, she and her husband David began TVT-NO! a nonprofit organization that raises funds to help other women with mesh find medical solutions as well as outreach and education. When they asked one of the nurses how they learned about mesh, she said the pharmaceutical company rep.

About Levana Layendecker

Levana Layendecker has been a political activist and professional organizer for over fifteen years. She started out working as a campus organizer and canvass director for the State PIRG’s (Public Interest Research Groups) after finishing her undergrad degree and went on to become the Web Communications Director for the American Friends Service Committee while obtaining a Master’s degree in Governmental Administration from the Fel’s Institute of Government at the University of Pennsylvania. After receiving her degree, Ms. Layendecker worked on the health care reform campaign in Washington D.C. as the Director of Online Campaigns for Health Care for America Now, a grassroots coalition mobilizing millions to win a guarantee of quality, affordable health care. She most recently served as the Senior Strategist for MoveOn.org’s coordinated campaigns helping to support progressive candidates for Congress across the country.

About Jane Akre

Jane Akre has been a journalist for nearly 30 years working as a broadcaster, anchor, and reporter at stations all around the country as well as CNN. She has won numerous awards including the Society of Professional Journalists Award for Ethics as well as the Goldman Prize, North America 2001 for environmental reporting. Ms Akre began the website Mesh Medical Device News Desk (Mesh News Desk) in 2011 to investigate the many stories she was hearing

Read at BioSpace.com
http://johnsonandjohnsonhurtswomen.org DEMAND AN INVESTIGATION The Corporate Action Network is launching an unprecedented campaign to hold Johnson and Johnson and its top executives accountable for their pattern of reckless conduct that has seriously injured women across the United States who have been implanted with the corporation’s pelvic mesh products. We need corporations like Johnson and Johnson to stop putting profits over the health and safety of women. Read our letter to Senator Kay Hagan below and add your name to join our call to investigate! The Honorable Kay Hagan Chairwoman Subcommittee on Children and Families 521 Dirksen Senate Office Building Washington, DC  20510 Dear Senator Hagan, On behalf of women survivors in North Carolina and across the country, we respectfully request a US Senate investigation by your subcommittee into actions by Johnson and Johnson and its top executives for their pattern of reckless conduct that has seriously injured women across the United States who have been implanted with the corporation’s pelvic mesh products. Today there are 30,000 defective product lawsuits filed against J&J in the U.S. and a growing number worldwide, more than any of the five other major manufacturers. As many as 30 percent of women implanted are unable to work and function and are referred to pain management.  What the future holds for these women as the mesh continues to degrade inside their bodies is unknown as the company chose not to study the long-term effects. One recent plaintiff called her implant a “ticking time bomb.”   Last month we delivered a letter to the Department of Justice asking for a criminal investigation of Johnson and Johnson for destroying thousands of documents related to the development of pelvic mesh, a move that could undermine these women’s ability to receive justice.   The Department of Justice is currently reviewing our call to investigate, and we need your help.  Corporations like Johnson and Johnson must stop putting profits over the health and safety of women. Johnson & Johnson need to be held accountable as part of a larger war on women that stretches from Congress to the corporate boardroom.  These women don’t need evasive responses and blaming survivors by Johnson and Johnson’s executives; they need help, now. That Johnson and Johnson and its CEO Alex Gorsky continue to claim that the destruction of thousands of documents was “limited” is not only evasive – it is a slap in the face to the thousands of women injured by Johnson and Johnson who are seeking justice. And this is just the tip of the iceberg.  The Wall Street Journal recently reported conflicts of interest with Johnson and Johnson and a physician who sought to change the language of the treatment guidelines on pelvic mesh.   The WSJ discovered that Johnson and Johnson had paid the physician $800,000 in exchange for his influence over the regulatory process.   Johnson and Johnson’s destruction of evidence may also be violating a Deferred Prosecution Agreement with the Department of Justice. Such an investigation is urgent.  There are estimated to be hundreds of thousands of women who have been implanted – and continue to be implanted – with these dangerous products.   These women need your help to hold Johnson and Johnson and its top executives accountable.  Johnson and Johnson must stop putting profits over the health and safety of women   Sincerely, Jane Akre Spokeswoman Johnson and Johnson Hurts Women