Preview Newsletter
Ethicon Media Monitoring 9/8/2017
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J&J hit with $57 mln verdict in latest pelvic mesh trial
Sep 8, 2017 | Reuters
By Tina Bellon
A Pennsylvania jury on Thursday found Johnson & Johnson subsidiary Ethicon liable for the injuries of a woman who had been implanted with two of the company’s pelvic mesh devices, awarding her $57 million, the highest in a pelvic mesh case to date. -
J&J Slammed With $57M Verdict In Philly Mesh Case
Sep 7, 2017 | Law 360
By Matt Fair
A Philadelphia jury on Thursday awarded $57.1 million in damages to a woman who accused a Johnson & Johnson unit of manufacturing a defective pelvic mesh implant that scarred her urethra and left her incontinent. -
Jury Hits J&J With Record $57.1M Verdict in Pelvic Mesh Case
Sep 7, 2017 | The Legal Intelligencer
By Max Mitchell
A Philadelphia jury has handed up a $57.1 million verdict against Johnson & Johnson subsidiary Ethicon after a trial over allegations that its transvaginal mesh product was defective. -
J&J’s Ethicon hit with $57m verdict in pelvic mesh case
Sep 7, 2017 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $57.1 million verdict in a pelvic mesh case out of Pennsylvania, according to a report from The Inquirer. -
J&J unit ordered to pay $57.1M to Pa. woman in pelvic mesh suit
Sep 7, 2017 | The Philadelphia Inquirer
By Sam Wood
A Philadelphia jury on Thursday ordered a subsidiary of Johnson & Johnson to pay $57.1 million in damages to a Pennsylvania woman who was left chronically incontinent and in constant pain after receiving defective pelvic mesh implants. -
*Breaking** Sixth Verdict Awards Mesh-Injured Plaintiff $57 Million in Philadelphia Trial
Sep 7, 2017 | Mesh Medical Device Newsdesk
A Philadelphia jury today delivered a $57 million verdict in the case of mesh-injured Ella Ebaugh, deciding that Johnson & Johnson’s subsidiary, Ethicon, is liable for the Pennsylvania woman’s damaged urethra, the result of two pelvic mesh implants made by the healthcare giant. -
Manchester woman awarded $57 million in vaginal mesh lawsuit
Sep 7, 2017 | York Dispatch
By David Weissman
A 51-year-old Manchester woman was awarded more than $57 million for injuries she suffered from vaginal mesh devices. -
York County woman to receive $57.1M after implants 'eroded'
Sep 7, 2017 | York Daily Record/Sunday News
By Sydney Musser
A York County woman will be receiving $57.1 million in damages after she was left chronically incontinent and in constant pain after faulty pelvic mesh implants eroded into her urethra, according to a report by The Inquirer. -
Here Are The Most Heartbreaking Letters To An Inquiry On Mesh Implants
Sep 8, 2017 | BuzzFeed News
By Gina Rushton
"This is, I believe, one of the greatest medical scandals and abuses of mothers in Australia's history," senator Derryn Hinch said before an ongoing Senate inquiry into transvaginal mesh implants.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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J&J hit with $57 mln verdict in latest pelvic mesh trial
Sep 8, 2017 | Reuters
By Tina Bellon
A Pennsylvania jury on Thursday found Johnson & Johnson subsidiary Ethicon liable for the injuries of a woman who had been implanted with two of the company’s pelvic mesh devices, awarding her $57 million, the highest in a pelvic mesh case to date.
The jury in the Philadelphia Court of Common Pleas found Ethicon defectively designed the devices and failed to warn plaintiff Ella Ebaugh of the risks associated with the mesh implants. The verdict includes $7.1 million in compensatory and $50 million in punitive damages.
To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2f8RZr7
https://www.reuters.com/article/ethicon-lawsuit/jj-hit-with-57-mln-verdict-in-latest-pelvic-mesh-trial-idUSL2N1LO2EL
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J&J Slammed With $57M Verdict In Philly Mesh Case
Sep 7, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (September 7, 2017, 2:48 PM EDT) -- A Philadelphia jury on Thursday awarded $57.1 million in damages to a woman who accused a Johnson & Johnson unit of manufacturing a defective pelvic mesh implant that scarred her urethra and left her incontinent.
The award, which included $50 million in punitive damages, easily eclipses verdicts won by plaintiffs in four prior cases tried in the Philadelphia County Court of Common Pleas as part of a mass tort program over allegedly defective pelvic mesh implants sold by Ethicon Inc.
The jury on Thursday unanimously backed claims from plaintiff Ella Ebaugh that a pair of negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.
Kila Baldwin, an attorney with Kline & Specter PC representing Ebaugh, said she hoped the verdict sent a message to Ethicon.
“Hopefully they recognize that their conduct was reckless,” she told Law360. “I hope this sends a clear message that they did something wrong with these products and that they really think, going forward, about what they do.”
Ebaugh’s case, which kicked off in early August, focused on two Ethicon mesh products — the TVT- Secur, which is no longer on the market, and the company’s “standard” TVT product, which is still being sold.
Ebaugh was implanted with a so-called TVT-Secur mesh device in May 2007 to treat symptoms of stress urinary incontinence and ultimately received a second TVT implant in the summer after her condition did not improve.
After reporting to her doctor three years later that she was having sudden urges to urinate and significant pelvic pain, it was discovered that the mesh had eroded into her urethra.
A series of surgical interventions followed that included one operation in which Baldwin said her client was cut open from “hip to hip” in an effort to remove as much of the mesh as possible. Despite the operations, scarring from the mesh implants had essentially propped open her urethra and left her all but incontinent, Baldwin told jurors during closing arguments on Tuesday.
Ethicon came into the Ebaugh case with a losing record after four out of five juries in prior trials in Philadelphia County sided with plaintiffs to the tune of nearly $50 million in total damages.
A jury in the fifth case decided in June that while the TVT-Secur had been defectively designed, it was not the cause of an Ohio woman’s injuries. A judge, however, agreed a month later that the verdict was inconsistent and ordered a new trial on damages.
Until Thursday, the largest verdict the company had faced in a mesh case in Philadelphia had been a $20 million award handed down in April. That award included $17.5 million in punitive damages.
Ethicon spokeswoman Kristen Wallace said in a statement on Thursday that the company "empathized" with individuals suffering from urinary stress incontinence and stood behind the safety and efficacy of its products.
"We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems," she said.
She added that the company planned to appeal.
Ebaugh is represented by Kila Baldwin of Kline & Specter PC.
Ethicon is represented by W. Curt Webb and Kat Gallagher of Beck Redden LLP.
The case is Ella Ebaugh et al. v. Ethicon Inc. et al., case number 130700866, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Dan Packel. Editing by Christine Chun.https://www.law360.com/articles/961734/j-j-slammed-with-57m-verdict-in-philly-mesh-case
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Jury Hits J&J With Record $57.1M Verdict in Pelvic Mesh Case
Sep 7, 2017 | The Legal Intelligencer
By Max Mitchell
A Philadelphia jury has handed up a $57.1 million verdict against Johnson & Johnson subsidiary Ethicon after a trial over allegations that its transvaginal mesh product was defective.
The jury award, handed up Thursday in Ebaugh v. Ethicon, was composed of $7.1 million in compensatory damages and $50 million in punitive damages.
According to a review of The Legal's archives, the verdict is a record award for the pelvic mesh program in Philadelphia, which has seen several multimillion-dollar verdicts since the first pelvic-mesh-related case was tried in late 2015. The verdict is more than twice the second-largest award out of the program, a $20 million verdict a jury handed up in May.
The case was tried by Kline & Specter attorneys Kila Baldwin, Tracie Palmer and Elia Robertson.
"I am pleased the jury recognized the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly," Baldwin said in a statement.
A spokeswoman for Ethicon said the company plans to appeal.
"We believe the evidence showed Ethicon's TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff's continuing medical problems," Kristen Wallace said in an emailed statement.
Kat Gallagher of Beck Redden tried the case for Ethicon.
The trial lasted about a month, and the jury deliberated for more about two days, according to Baldwin.
Philadelphia Court of Common Pleas Judge Michael Erdos presided over the trial.
More than 100 cases are pending in Philadelphia's pelvic mesh mass tort program. J&J, however, has recently stepped up efforts to have those cases removed from Philadelphia based on a U.S. Supreme Court ruling from June that some have described as "game-changing" for mass tort programs.
That Supreme Court's decision, which came in the case Bristol-Myers Squibb v. Superior Court of California, made clear that out-of-state plaintiffs can't sue companies in states where the defendants aren't considered to be "at home," or haven't conducted business directly linked to the claimed injury.
That ruling is not likely to factor into Ebaugh, as plaintiff Ella Ebaugh is a Pennsylvania resident, according to court papers.
According to Ebaugh's pretrial memo, she is in her 50s and was diagnosed with urinary incontinence in 2005. In 2007, she had TVT-Secur mesh installed, but, after she reported that it did not provide any relief, a second device was implanted about two months later. According to the memo, over the following few years, that device eroded through her urethra on three occasions, requiring three revision surgeries between 2011 and 2016.
http://www.thelegalintelligencer.com/id=1202797481939/Jury-Hits-JJ-With-Record-571M-Verdict-in-Pelvic-Mesh-Case?mcode=1202617075166&curindex=1
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J&J’s Ethicon hit with $57m verdict in pelvic mesh case
Sep 7, 2017 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $57.1 million verdict in a pelvic mesh case out of Pennsylvania, according to a report from The Inquirer.
A jury in Philadelphia ordered the subsidiary to pay the damages to a woman who was left chronically incontinent and with chronic pain after being implanted with a defective pelvic mesh implant, according to the report.
The plaintiff, Ella Ebaugh, received 2 Ethicon mesh implants which later eroded into her urethra, according to The Inquirer, and required 3 surgeries to remove the meshes.
The damages awarded are greater than those won by plaintiffs in 4 previously tried cases in Philadelphia as part of a mass tort program for trials related to the implants.
Previous victories included a $12.5 million award in December 2015, a $13.5 million award last February, a $20 million award this April and another $2.1 million to a Pennsylvania woman in June, according to the paper.
Ethicon told The Inquirer that it plans to appeal the verdict.
“We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems,” Ethicon spokesperson Kristen Wallace told The Inquirer.
http://www.massdevice.com/jjs-ethicon-hit-57m-verdict-pelvic-mesh-case/
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J&J unit ordered to pay $57.1M to Pa. woman in pelvic mesh suit
Sep 7, 2017 | The Philadelphia Inquirer
By Sam Wood
A Philadelphia jury on Thursday ordered a subsidiary of Johnson & Johnson to pay $57.1 million in damages to a Pennsylvania woman who was left chronically incontinent and in constant pain after receiving defective pelvic mesh implants.
Ella Ebaugh, 51, of York County, received two implants of the Ethicon devices, which later eroded into her urethra, said her attorney, Kila Baldwin of Kline & Specter. Surgeons operated three times to remove the devices.
The Common Pleas Court verdict is the fifth, and largest yet, awarded in a pelvic mesh suit, Baldwin said, It included $50 million in punitive damages. In December 2015, an Indiana woman was awarded $12.5 million; in February 2016, a New Jersey woman received a $13.5 million award; in April 2017, a Cinnaminson woman was awarded $20 million; and in June, a Pennsylvania woman received $2.1 million.
A spokeswoman for Ethicon said the company would appeal the verdict.
“We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems,” said Kristen Wallace.
Thousands of women are believed to have been implanted with the devices, said Baldwin, who tried the case with Tracie Palmer and Elia Robertson, also of Kline & Specter.
Evidence introduced during the trial asserted J&J intentionally manipulated the literature regarding problems with the products and withheld information about complications and injuries from doctors, Baldwin said.
“I am pleased the jury recognized the reckless conduct of Johnson & Johnson,” Baldwin said, “and I hope the company takes notice of this verdict and the other verdicts in Philadelphia and amends its practices accordingly so as not to hurt other women.”
http://www.philly.com/philly/business/jj-unit-ordered-to-pay-57-1m-to-pa-woman-in-pelvic-mesh-suit-20170907.html
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*Breaking** Sixth Verdict Awards Mesh-Injured Plaintiff $57 Million in Philadelphia Trial
Sep 7, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 6, 2017 ~ A Philadelphia jury today delivered a $57 million verdict in the case of mesh-injured Ella Ebaugh, deciding that Johnson & Johnson’s subsidiary, Ethicon, is liable for the Pennsylvania woman’s damaged urethra, the result of two pelvic mesh implants made by the healthcare giant.
The case no 130700866, began July 31 before a dozen jurors, all African-American, half men, half women and all middle aged.
In her closing Tuesday, Kline Specter attorney Kila Baldwin told the jurors to send a strong message to J&J by granting large punitive damages to plaintiff Ebaugh. This jury award includes $50 million in punitive damages and $7 million in compensatory damages.
The jurors were asked whether TVT or TVT-S were defective in design. They said “Yes.” Jurors also found the company’s conduct was negligent.
A J&J spokeswoman said the company will appeal the verdict.
The Inquirer reports a J&J statement:
“We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems,” said Kristen Wallace.Ebaugh, 51, claimed she suffered permanent, life-altering damage from two mesh implants made by Ethicon. Both the TVT (Tension-free tape) and TVT-SECUR mesh are used to treat incontinence. Her urethra was “mangled” from the TVT-SECUR, which eroded into her urethra.
This is the sixth trial against J&J and its pelvic mesh products to be held in the Philadelphia Court of Common Pleas. All five previous product liability trials had found the pelvic meshes made were defective in their design. The TVT-SECUR has been found defectively design in two previous trials in this venue.
Kila Baldwin tells Mesh News Desk one juror told the law firm that the documents about the TVT-SECUR were indefensible.
Baldwin says “Their claims from the Key Opinion Leaders (KOL) that they wouldn’t support the product, J&J knew it was defective and they said to “jazz” and “spin the data.” KOL leader Vincent Lucente showed different rates of success that were inconsistent.”
Philly.com reports:
“I am pleased the jury recognized the reckless conduct of Johnson & Johnson,” Baldwin said, “and I hope the company takes notice of this verdict and the other verdicts in Philadelphia and amends its practices accordingly so as not to hurt other women.”All but one of the previous trials in this court delivered compensatory and punitive damages. So far in this Philadelphia court all seven meshes on trial have been found defective in design.
J&J and Ethicon has been ordered to pay mesh-injured women in this court a total of $105 million.
There are more than 100 other product liability trials waiting to be heard in the Philadelphia Court of Common Pleas. Additionally there are 104,000 product liability trials naming seven mesh makers waiting for trial consolidated in federal court in West Virginia, and several thousand cases waiting to be heard in Bergen Co., New Jersey as well as various defective product cases filed around the country.
According to the recent J&J SEC report, the mesh manufacturer has 55,000 pending defective product cases filed against it, more than any other maker. ##
LEARN MORE:
Past Pelvic Mesh Cases in Philadelphia Court of Common Pleas
$2.16 million – Sharon Beltz, Prolift mesh, no punitive damages
https://www.meshmedicaldevicenewsdesk.com/beltz-case-jj-jury/$12.5 million – Patricia Hammons including $7 million in punitive damages over Prolift mesh. Defective design,https://www.meshmedicaldevicenewsdesk.com/philadelphia-prolift-mesh-case-yields-12-5-million-verdict-for-plaintiff/
$13.5 million – Sharon Carlino including $10 million in punitive damages, TVT mesh
https://www.meshmedicaldevicenewsdesk.com/just-in-carlino-pelvic-mesh-found-defective-awards-13-5-million-against-jj/$20 million – Peggy Engleman, includes $17.5 million in punitive damages. TVT-SECUR
https://www.meshmedicaldevicenewsdesk.com/14521-2/$0 – Kimberly Adkins, TVT-SECUR, defective design but did not cause her complications
https://www.meshmedicaldevicenewsdesk.com/jj-wins-first-pelvic-mesh-trial-philadelphia/$57-million – Ella Ebaugh, includes $50 million in punitive damages and defective design TVT and TVT-SECUR and negligent conduct
Mesh News Desk, August 23, 2017 ~ “Show Me The Money”
https://www.meshmedicaldevicenewsdesk.com/inside-ebaugh-v-ethicon-pelvic-mesh-trial/Mesh News Desk, August 29, 2017, Defense Opens Case – Just because she had a bad outcome doesn’t mean the mesh is defective
https://www.meshmedicaldevicenewsdesk.com/ebaugh-trial-continues-jj-defends-tvt-secur/Mesh News Desk, September 1, 2017 ~ Tricks to the TVT-SECUR
https://www.meshmedicaldevicenewsdesk.com/doctors-weigh-tvt-secur-ebaugh-pelvic-mesh-trial-philadelphiaMesh Medical Device News Desk, September 5, 2017 ~ Medical Expert- No Problem with TVT-S
https://www.meshmedicaldevicenewsdesk.com/jj-medical-expert-no-problems-tvt-secur/https://www.meshmedicaldevicenewsdesk.com/breaking-sixth-verdict-awards-mesh-injured-plaintiff-57-million-philadelphia-trial/
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Manchester woman awarded $57 million in vaginal mesh lawsuit
Sep 7, 2017 | York Dispatch
By David Weissman
A 51-year-old Manchester woman was awarded more than $57 million for injuries she suffered from vaginal mesh devices.
The devices, created and marketed by Johnson and Johnson subsidiary Ethicon Inc., were implanted into Ella Ebaugh in 2007 to treat her stress urinary incontinence, according to her attorney, Kila Baldwin.
Baldwin said the devices, called TVT and TVT-Secur, were effective in treating that minor condition, but years later, the mesh later eroded into Ebaugh's urethra, which required three separate surgeries to remove.
Ebaugh's injuries included extensive scarring to her urethra, intrinsic sphincter deficiency, chronic urinary tract infections, chronic pelvic pain and dyspareunia, or chronic pain during sex, according to the lawsuit, filed in the Philadelphia Court of Common Pleas.
The lawsuit claimed that Johnson and Johnson intentionally manipulated available information regarding issues with the devices and withheld information about issues and injuries from doctors.
The device was approved by the U.S. Food and Drug Administration but didn't go through the FDA's Premarket Approval process, Baldwin said.
Under current federal law, companies are immune from lawsuits related to devices that make it through that process.
The verdict, handed down Thursday, Sept. 7, is the fifth successful lawsuit filed in Philadelphia related to these devices, according to Baldwin, and Ebaugh's award is the largest of those five.
The award included $7.1 million in compensatory and $50 million punitive damages. Though Ebaugh has been unable to return to work due to her injuries, Baldwin said they did not seek economic damages.
Prior to her injuries, Ebaugh was a clerical worker at a Friendly's distribution center, Baldwin added.
More than 100 lawsuits against Johnson and Johnson related to its mesh devices are still pending in Philadelphia courts, according to Baldwin.
Ethicon spokeswoman Kristen Wallace wrote in an email that the company plans on appealing the court's verdict.
"We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems," Wallace wrote in a statement.
“We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition," she continued. "There are various treatment choices for women with this condition seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment."
Ebaugh was not immediately available for comment.
— Reach David Weissman at dweissman@yorkdispatch.com.
http://www.yorkdispatch.com/story/news/local/2017/09/07/manchester-woman-awarded-57-million-vaginal-mesh-lawsuit/643463001/
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York County woman to receive $57.1M after implants 'eroded'
Sep 7, 2017 | York Daily Record/Sunday News
By Sydney Musser
A York County woman will be receiving $57.1 million in damages after she was left chronically incontinent and in constant pain after faulty pelvic mesh implants eroded into her urethra, according to a report by The Inquirer.
A Philadelphia jury ordered a subsidiary of Johnson & Johnson to award Ella Ebaugh, 51, on Thursday, according to the report. Ebaugh received two implants of the Ethicon devices, which later required surgeons to operate on three times to remove the devices.
Thousands of women are believed to have been implanted with the devices, said Ebaugh's attorney, Kila Baldwin of Kline & Specter. The Common Pleas Court verdict is the fifth and largest awarded in a pelvic mesh suit, and included $50 million in punitive damages, she added.
A spokeswoman for Ethicon said that the company would appeal the verdict, the report states.
http://www.ydr.com/story/news/2017/09/07/york-county-woman-receive-57-1-m-after-implants-eroded/643975001/
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Here Are The Most Heartbreaking Letters To An Inquiry On Mesh Implants
Sep 8, 2017 | BuzzFeed News
By Gina Rushton
"This is, I believe, one of the greatest medical scandals and abuses of mothers in Australia's history," senator Derryn Hinch said before an ongoing Senate inquiry into transvaginal mesh implants.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
Queensland associate professor of urogynaecology Christopher Maher has estimated more than 200,000 mesh implant surgeries have been performed in Australia to date.
The inquiry, which reports in November, was set up to find out exactly how many women have had transvaginal mesh implants and, of those, who had experienced adverse side effects.
More than 100 women have written to the inquiry. Their stories share much in common.
Every submission claims there was no informed consent or awareness of the possible complications. And every submission details a complication after the mesh was inserted.
These include: chronic and constant vaginal pain, visceral pain with bowel movements; dyspareunia (pain during sex); vaginal bleeding; inability to sit for more than an hour at a time; the granulation of vaginal tissue; pain through the glutes; inflammatory reactions; "offensive discharge"; incontinence; leg weakness; and haemorrhages.
Dozens of women described "erosions" — when the product enters surrounding tissue, protrudes out of a body structure or tissue and into surrounding organs causing holes or even haemorrhaging.
One woman had more than 12 operations to treat erosions and attempt to remove parts of her implant which were threatening to puncture surrounding organs.
Not one woman claims she knew the device, which is polypropylene and non-absorbable, acted as a permanent implant.
There are few surgeons in Australia trained to even partially remove the implants.
In May, patients told BuzzFeed News they had flown to the United States at huge financial cost to attempt surgery to remove their implants.
Any discomfort borne of the initial urinary incontinence — which in some cases was as minor as some leakage when running down hills — pales in comparison to the daily, debilitating and finance-draining reality of life the women who wrote to the inquiry say they experience after an implant.
Most of the submissions detail devastating mental health challenges women have faced having to negotiate newfound pain and ongoing sexual, urinary and bowel dysfunction; the toll this has taken on their finances; the forgone holidays and relationships; the inability to play with their kids; a complete loss of a sex life and for some, divorce.
Just weeks after her transvaginal mesh device was inserted in 2009, this woman was having sex with her husband when he screamed.
"His penis had been cut," she wrote in her submission to the inquiry, explaining that the device had eroded through to her vagina.
"The second time the mesh came down into the vagina wall I was in great pain and bleeding and the third time they removed the mesh and put in a mesh sling.
"I have extreme nerve pain in the vagina and it is now impossible for me to have intercourse with my husband anymore."
The New South Wales women said she had been offered various remedies by doctors over the past seven years including physiotherapy, painkillers and anti-depressants.
"Who is answerable for this medical disgrace?" she asked.
"My life is never going to be how it should be."
In 2009, a 62-year-old former registered nurse had a mesh inserted and sutured to treat uterovaginal prolapse.
Her muscles spasmed for years after the operation, she said — “it felt like the front of me was being pulled to the back.”
Her mental health deteriorated.
“My GP wrote a mental health care plan so that I can deal with my anger about the dodgy surgery, not being able to nurse and the effect on my sex life.”
The pain was so unbearable she planned her own suicide.
“I had decided 20 to 30 years of severe pain was more than I could bear," she wrote. "I had started to collect the medications I thought I would need and had decided on the beach I would go to for my last swim.”
She had three operations to remove the mesh and the third was successful in removing enough that she decided not to “carry out her plan” to kill herself.
“I still have chronic pain but at a level that I can have a reasonable life. I am fortunate that I only need paracetamol every day and ibuprofen when I overstep what my mesh allows me to do.”
“My children have grown up with a mother who has spent so much of her time in bed, and my intimate relationship with my husband no longer exists,” a 58-year-old Victorian woman wrote in her submission.
Since the insertion of a transvaginal mesh implant for a bladder and vaginal prolapse in 2000, the woman has spent thousands of dollars for 12 subsequent surgeries including the last one which cost her $8,000, she wrote.
“I’ve had severe abdominal pain, erosion of the mesh through the vaginal wall twice … ongoing pain, bladder problems, bowel problems, vaginal problems.
“It has been over 16 years and I was 38-years old at the time of my initial surgery.
“I have been told by doctors that what has happened to me has been 'a disaster', 'a bloody mess' and 'should never have happened'.
“This is my life now and I can only imagine what life would have been like had I never had the mesh sling put into my body.”
“May they rot in hell!” one 65-year-old woman ended her submission addressed to the “pretty disgusting human beings” who manufactured and sold transvaginal mesh implants.
In 2008 she had a transvaginal mesh implant for a bladder prolapse and was left in “excruciating pain”.
“It incapacitated me at a critical time as mother of three young children and as a wife.
“There are many things I can no longer do … lost opportunities, horrendous medical expenses, bouts of depression, chronic pain and discomfort and continuous bladder prolapse issues.”
The adverse side effects she said she suffered included bladder dysfunction, nerve pain, mesh erosion, inability to exercise without pain or discomfort, a “ruined sex life” and “an almost failed marriage”.
She had three surgeries to remove the mesh over the next two years.
“They should have told me that class actions were already starting in the United States before I allowed them to put this rubbish in my system.”
A now 60-year-old Western Australian woman said she was told a mesh implant “was the only option other than a hysterectomy” to treat her uterus prolapse.
Since the surgery she has ongoing urinary tract infections, back pain, pelvic spasms, faecal and urinary urgency and painful sexual intercourse
Her relationship at the time fell apart “due to the anguish, stress and the inability [for her to participate in] sexual relationships” and her following relationship ended for the same reasons.
She said she wasn’t told of any risks or complications associated with the device.
Three surgeons have told her that they can’t remove the mesh as it is “entwined with the tissue”.
“I feel I no longer can have a sexual relationship, which has left me feeling depressed and alone.”
One 61-year-old NSW woman had a mesh implant inserted for a vaginal prolapse at the same time as her hysterectomy was performed in 2006. Just 11 months later she had to have another operation to “correct the prolapse”, yet the device continued to erode.
“I suffered severe lower abdominal pain and a very unpleasant discharge which forced me to wear sanitary pads both day and night for eight years due to the odour,” she wrote.
“I have not had any sexual activity for over eight years … as it was too embarrassing to explain and as the mesh continued to erode, it was exposed and rough so I avoided intimate situations at all costs."
She had an operation to remove part of the mesh.
“I no longer have the discharge but I still live in fear that the remaining mesh may over time erode and as it is located so close to my bowel and other internal organs they may perforate and be life threatening.”
In one of the most recent submissions, a woman who had a mesh inserted into her vagina for a prolapsed bladder in 2007 says she has since had 12 procedures to correct subsequent complications.
The woman said she spent months on morphine for the pain from the initial insertion and had multiple surgeries to deal with parts of the device which had protruded through the vagina and bowel.
She was dismissed from her job for being “unreliable”, which she wrote was because she had to take so much time off for appointments, surgery and recovery time.
“After 10 years of constant pain and 12 procedures and visits to [a doctor] for check-ups and operations, my life has been quite miserable,” she wrote.
“Not to mention that my husband has had to have time off work to look after me and our quality of life has been severely diminished.
“I feel that this mesh was not tested enough.”
“The doctor did not tell me about any side effects or complications,” one woman wrote in her submission.
“I was advised it would be day surgery and I was in hospital for two weeks.”
The complications — sleep disturbance, bowel dysfunction, urinary incontinence and pain — have left her feeling like the only thing she wants to do is to “crawl back into bed” in the decade since her 2007 operation.
“I have been unable to be intimate with my partner of 40 years since the operation and this has put an enormous strain on our relationship.”
The health problems had led to “mood swings” that caused her to snap at her family.
“My quality of life is low, I had plans to travel to Ireland and see where my ancestors lived but that dream has been taken away from me.”
A 62-year-old South Australian woman said she had a mesh device inserted in 2010 for a prolapse and incontinence issue and has since had four operations to remove it.
“My life turned to hell [and I suffered] daily pain and discomfort,” she wrote.
The one thing she wished women were told before receiving a transvaginal mesh implant?
“Don’t use this product, ever.”One woman had a transvaginal mesh implant in 2008 and has spent almost a decade treating paraesthesia (pins and needles), piriformis muscle pain, groin pain, sciatic pain and foot pain.
“[My surgeon] didn’t inform me that the mesh could not be removed by himself or any Australian surgeon if I developed any complications,” she wrote.
“He failed to tell me that complications such as foreign body response, pudendal nerve entrapment syndrome, painful sex, nerve pain, faecal incontinence, bladder incontinence or mesh erosion would be likely after surgery and would impair my life forever. I have had all [of these] complications.”
She “felt isolated and alone”.
“My husband said it was like I was flatlining,” she wrote.
"I didn't care if I lived or died."
Her favourite activities — “road trips, reading and knitting” — were no longer possible because she can’t sit for too long without pain.
“I increased my alcohol consumption and put on 15 kilos due to depression and then was diagnosed with fatty liver disease.”
One woman wrote a submission on behalf of her mother who she said had suffered vaginal bleeding, “constant urinary tract infections”, “chronic groin, hip and leg pain”, gluteal tears and bursitis (inflammation of the fluid-filled pads — bursae — that act as cushions at the joints).
“I have lost count of the number of times I witnessed my mother cry out in pain from leg spasms and cramps,” she wrote.
“I believe that my mother’s legal rights and ethical rights of informed consent, fidelity and do no harm were dismissed and ignored by the medical company that produced her device, the surgeon who implanted the device and the Therapeutic Goods Association [sic] who approved this device for the Australian market.”
A single mother from Western Australia was fitted in 2007 with an implant, since removed from Australia's market by the Therapeutic Goods Administration, for a vaginal prolapse.
“I have suffered with chronic pelvic and rectal pain, reoccurring prolapse, loss of sex life, clinical depression due to emotional trauma for numerous surgeries and pain, chronic fatigue, nerve pain, fibromyalgia, constant sweating just to mention a few long term side effects,” she wrote.
The 54-year-old said she was never provided with any information about long-term health issues or possible side-effects.
This woman described herself as a "fairly active" wife and mother-of-four before she had a mesh tape implanted in 2010.
"I was told at the time that this was the gold standard in treating stress urinary incontinence and that it was a day procedure, very safe and came with only minor risks associated with all surgeries," she wrote.
What started as a "dull ache" turned into a pain so severe that she "could barely sit" by 2016 when a surgeon operated to remove part of the mesh.
"Almost immediately I began experiencing severe pain in my vagina," she wrote.
"Some days it felt like a hot knife in my vagina and the pain also started to migrate to my bottom and my legs.
"This was attributed to the mesh eroding through the vaginal wall."
Her mesh was removed by a surgeon in Melbourne in March this year.
"While feeling better ... I am left with pudendal nerve damage, fibromyalgia, inability to sit or stand for any length of time, inability to be intimate or have sexual relations with my husband, inability to pursue an active lifestyle and the ability to attend sport practices, events, movies, dinners or parent/teacher conferences due to the pain in my vaginal and gluteal areas.
"I now spend most of my days lying on one side or the other as to avoid direct pressure on my vagina and my bottom."
One 72-year-old woman wrote that she had suffered for 14 years and "never recovered" after having a transvaginal mesh implant inserted to "repair a tear in the wall of the vagina".
"Pain is with you all the time, I have infections and discharge and I've had four erosions which put me in the hospital where the surgeon removed pieces of the mesh each time.
"I can feel the mesh when it moves it feels like a razor blade inside you ... the doctor said if I start haemorrhaging to go straight to a hospital.
"I hope I get rid of this mesh one day. I'd be a very happy healthy 72-year-old and have a normal life, what's left of it for me."
This 58-year-old Sydney registered nurse and medical clinic operator was “physically” active and loved gym sessions, weight lifting and running before she had an implant.
She had slight urinary leakage when she ran down steep hills during her exercise so her doctor suggested a mesh implant.
“Because of my profession and medical history as a registered nurse I researched the mesh and found them to be very controversial,” she wrote in her submission.
“My initial investigations were dismissed as the doctor described the operation to not involve any issues.”
She had a vaginal hysterectomy at the same time.
The pain after the operation was “excruciating” but she thought it was part of the recovery process.
Months later her gynaecologist suggested another operation to remove some of the mesh.
“I had no choice but to have the operation even though I do not have loss of income insurance.”
The symptoms continued and she was referred to a pain management doctor.
After visiting a number of specialists she had six hyaluronic acid injections to restore function in her damaged nerves but they have offered no relief.
She is now considering a trip to the United States for a removal of the mesh which would cost her an estimated $25,000.
Many other Australian women found their only option for removal in St. Louis, Missouri, with obstetrician-gynecologist Dionysios Veronikis, who is now training professor Thierry Vancaillie, who runs the Women's Health and Research Institute of Australia in Sydney, in mesh removal.
Veronikis said he has performed more than 1,000 mesh removal surgeries since 1994, and seen a rapid increase in patients over the past five years.
The woman also wrote: “The direct medical cost and chronic pain married with the indirect suffering of my business has compounded to the point, any kind of blissful retirement in my mid-to-late 60’s has most likely been robbed.
“This journey of chronic pain and discomfort has exhausted my ambitions of living a fruitful life after the death of my partner of 40 years.”
Women across the world have taken legal action against the manufacturers of implants.
In the United States, Johnson & Johnson has lost at least five jury awards totalling more than $35 million over the mesh inserts since 2014, and earlier this year the manufacturer was ordered to pay US$20 million to a New Jersey woman who blamed the company's TVT-Secur mesh for her chronic and unresolved pain.
An estimated 100,000 Australian women have been implanted with Johnson & Johnson mesh devices since 2000.
More than 700 Australian women are currently in court fighting Ethicon, a subsidiary of Johnson & Johnson, in a class action which claims vaginal medical devices left women "suffering painful and life-altering complications".
The lawyers representing the women have said there could be upwards of 8,000 Australians who have been implanted with one of the nine devices.
Johnson & Johnson said the company's pelvic mesh products had been developed in "close consultation with specialist surgeons" and were "backed by years of clinical research".
In its submission to the Senate inquiry, the company said the use of implantable mesh was supported by clinical research and was often the preferred option to treat pelvic conditions, including incontinence and pelvic organ prolapse.
Another 300 Australian women have registered with Shine Lawyers for a second class action against American Medical Systems over 10 of its different mesh implants. Shine said the group may eventually exceed 2,000 women.
If you need to talk to someone, you can call Lifeline Australia on 13 11 14 or Beyond Blue Australia on 1300 22 4636. Anxiety UK on 08444 775 774, or Hopeline America on 1-800-784-2433.
https://www.buzzfeed.com/ginarushton/here-are-the-most-heartbreaking-letters-to-mesh-inquiry?utm_term=.hsWg9kVAX#.bd5JjaVvQ
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