Preview Newsletter
Ethicon Media Monitoring 5/01/2017
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J&J to Pay $20 Million in Vaginal-Mesh Case as Other Trials Loom
Apr 28, 2017 | Bloomberg
By Jef Feeley
Johnson & Johnson was ordered to pay $20 million to a New Jersey woman who blames the company’s vaginal-mesh inserts for leaving her in constant pain as the company prepares for a new wave of trials over the medical devices. -
Philadelphia jury awards $20M to Cinnaminson woman in pelvic-mesh trial
Apr 28, 2017 | Philly.com
By Chris Mondics
A Philadelphia Common Pleas Court jury has awarded $20 million to a Cinnaminson woman who charged that a vaginal-mesh product made by Johnson & Johnson failed to work as advertised, caused her chronic pain, and necessitated multiple corrective surgeries. -
Jury Hands Down $20 Million Verdict Against Johnson & Johnson Over Woman’s Vaginal Mesh Implant Injuries
Apr 28, 2017 | CBS Philly
A jury ruled that Johnson & Johnson needs to shell out millions for a New Jersey woman who suffered serious injuries after being implanted with a vaginal mesh device. -
Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case
Apr 28, 2017 | FOX 29 News Philadelphia
April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device. -
J&J Hit With $20M Pelvic Mesh Verdict In Philly
Apr 28, 2017 | Law 360
By Dan Packel
A Pennsylvania state jury hit Johnson & Johnson on Friday with a $20 million verdict over injuries suffered by a New Jersey woman after receiving a vaginal mesh implant, the third consecutive eight-figure award against Johnson & Johnson in the pelvic mesh mass tort program in Philadelphia County court. -
J&J Hit With $20M Verdict in Third Pelvic Mesh Trial
Apr 28, 2017 | The Legal Intelligencer
By Zack Needles
A 12-member Philadelphia jury handed up a $20 million verdict—including $17.5 million in punitive damages—against Johnson & Johnson subsidiary Ethicon in the third pelvic mesh case to go to trial in the city. -
*New** J&J Hit With $20 M Verdict in 3rd Philadelphia Pelvic Mesh Trial
Apr 28, 2017 | Mesh Medical Device Newsdesk
In the last 15 months J&J and its Ethicon medical device division has accrued $34.5 million in punitive damages over its transvaginal meshes. -
Vaginal mesh implant victim to be paid $20mn by Johnson & Johnson, PA jury orders
Apr 29, 2017 | RT
A state court jury has ordered Johnson & Johnson to pay $20 million verdict to a New Jersey woman who suffered injuries from an implanted vaginal mesh device. The company is currently being sued. -
Caz Chisholm recognised for campaign supporting women pelvic mesh victims
May 1, 2017 | Newcastle Herald
By Joanne McCarthy
A WOMAN who launched a campaign to support women victims of pelvic mesh and hold Australian health regulators to account has won two awards for consumer health advocacy. -
Mesh Implant ‘Guinea Pig’ Suing NHS Tayside For £100,000
May 1, 2017 | Evening Telegraph
By Will Lyon
The first woman to have a mesh implant fitted at Ninewells Hospital has launched a £100,000 compensation case against NHS Tayside. -
May Flowers and Mesh Friendships
Apr 30, 2017 | Mesh Medical Device Newsdesk
By Jane akre
Hello to everyone. I hope this May finds you in a hopeful mood and regaining your health. If not, I certainly hope you can connect with the mesh community that seems to be springing up all over the Internet! -
Women Suing Over Vaginal Mesh Complications Say Doctors Didn’t Inform Them Of Risks
Apr 28, 2017 | Verily
By Katie Faley
Many women are taking a stand against a controversial health issue that is causing some serious damage. Though many doctors have claimed that vaginal mesh devices are harmless and easy procedures, women who have had the surgery are experiencing side effects that are anything but harmless. -
Thousands of women sue Bayer over medical issues using Bayer's Essure
Apr 28, 2017 | Modern Healthcare
By Elizabeth Whitman
.... its Ethicon division stopped selling mesh urinary implants, over which women had filed thousands of lawsuits against the company alleging harm. The following year, a jury ordered J&J to pay $3.35 million to a woman because the company did not adequately warn her doctor about the implant's potential risks.
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J&J to Pay $20 Million in Vaginal-Mesh Case as Other Trials Loom
Apr 28, 2017 | Bloomberg
By Jef Feeley
Philadelphia jury found mesh device had defective design
Verdict includes $17.5 million in punishment damages
Johnson & Johnson was ordered to pay $20 million to a New Jersey woman who blames the company’s vaginal-mesh inserts for leaving her in constant pain as the company prepares for a new wave of trials over the medical devices.
A state-court jury in Philadelphia concluded Friday that J&J’s TVT-Secur mesh, designed to treat incontinence in women, was defectively designed and caused Margaret Engleman’s injuries. The panel awarded her $2.5 million and then hit J&J and its Ethicon unit with $17.5 million in punitive damages.
The verdict is the first against J&J over the vaginal-mesh devices in more than a year. The world’s largest maker of health-care products hasn’t faced any trials while it sought to negotiate settlements in some of the more than 54,000 lawsuits pending over the inserts. The company faces three more trials in Philadelphia in the next two months.
Kristen Wallace, an Ethicon spokeswoman, said the company will appeal the jury’s findings that the devices were defective and that the company failed to provide adequate warnings about the risks.‘Properly Designed’
“We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems,” Wallace said in an emailed statement.
J&J, based in New Brunswick, New Jersey, has lost at least five jury awards totaling more than $35 million over the mesh inserts since 2014. It has settled other cases, including one for as much as $5 million. The company has won several cases, including a 2015 lawsuit in Texas over its Prosima inserts. J&J is appealing some of the plaintiff’s wins.
Carl Tobias, who teaches product liability law at the University of Richmond in Virginia, said J&J should consider a comprehensive settlement to all the cases.
“It would be silly to continue taking these cases to trial when they are losing,” he said in an interview. “There’s no sense in continuing to shell out for the defense costs and suffer the reputation damage that comes with each win by the plaintiffs.”
For more on the lawsuits, click here.
Almost five years ago, J&J voluntarily pulled four lines of mesh inserts, including the TVT-Secur device, off the market after facing a wave of litigation. Ethicon is the J&J unit that sells the mesh.
The decision to stop selling the inserts came six months after regulators ordered J&J and more than 20 other makers of such devices, designed to treat incontinence and shore up weakened pelvic muscles, to conduct further studies about their health risks.
Engleman said the TVT-Secur mesh eroded once it was placed in her body in 2007, forcing her to undergo multiple surgeries to try and remove the mesh. The insert caused her “sharp stabbing pain” and exacerbated her bladder problems, according to court filings.
“I’m happy I could be a voice for other women,” Engleman said Friday in an emailed statement. “It’s been a nightmare.”
The case is Engleman v. Ethicon, No., 05385, Philadelphia County Court of Common Pleas.
https://www.bloomberg.com/news/articles/2017-04-28/j-j-is-ordered-to-pay-20-million-over-defective-vaginal-mesh
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Philadelphia jury awards $20M to Cinnaminson woman in pelvic-mesh trial
Apr 28, 2017 | Philly.com
By Chris Mondics
A Philadelphia Common Pleas Court jury has awarded $20 million to a Cinnaminson woman who charged that a vaginal-mesh product made by Johnson & Johnson failed to work as advertised, caused her chronic pain, and necessitated multiple corrective surgeries.
The award Friday — which included $17.5 million in punitive damages — followed a three-week trial in which the victim’s lawyers argued not only that the mesh was defective, but that Johnson & Johnson and its subsidiary Ethicon had concealed the risks of the product even as they were marketing it.
Peggy Engleman, 56, was implanted with the device in 2007 to relieve urinary incontinence. But within a month of surgery, the mesh failed and Engleman’s problems returned. Her lawyers said she began to experience pain and discomfort when the mesh started to erode inside her body.
Although she has had multiple surgeries as a result, her physicians have been unable to remove all of the shards of mesh that remain in her abdomen, a common complaint about the device.
“I am happy I could be a voice for other women,” Engleman said. “It’s been a nightmare, and I feel justice was truly served today.”
In a statement late Friday, Ethicon said, "We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems. Therefore, we are disappointed with today’s verdict and feel we have strong grounds for appeal."
The mesh product used to treat Engleman was launched in September 2006, but by then J&J had already had multiple complaints about it.
Pelvic-mesh implants came into wide use a decade ago for treatment of a condition in which the bladder and other abdominal organs, weakened by childbirth, sag over time, causing incontinence and other problems. Mesh implants, however, appear to cause problems of their own, degrading over time so that pieces of the original implant break off inside the body and pierce organs internally.
Johnson & Johnson faces tens of thousands of additional lawsuits in courts around the country, filed by women who allege that they were harmed by the company’s vaginal-mesh devices.
“The jury spoke, and they sent a message that J&J and Ethicon need to take responsibility,” said attorney Chris Gomez of Philadelphia-based Kline & Specter, one of the law firms representing Engleman.
Two earlier pelvic-mesh verdicts in Philadelphia against Johnson & Johnson, in 2015 and 2016, resulted in awards of $12.5 million and $13.5 million.
http://www.philly.com/philly/business/law/Jury-awards-20-million-to-woman-in-pelvic-mesh-trial.html
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Apr 28, 2017 | CBS Philly
PHILADELPHIA (CBS) — A jury ruled that Johnson & Johnson needs to shell out millions for a New Jersey woman who suffered serious injuries after being implanted with a vaginal mesh device.
The jury awarded 56-year-old Peggy Engleman $20 million — $2.5 million in compensatory and $17.5 in punitive damages – after her attorneys claimed during a three-week trial in Common Pleas Court that the TVT-Secur medical device was not only defective, but that Johnson & Johnson and its Ethicon subsidiary failed to warn of its risks.
Engleman had the device implanted in her in 2007 in an effort to relieve stress urinary incontinence. However, the implant failed and her condition returned. Attorneys argued that Engleman also began experiencing pain and discomfort when the polypropylene mesh from the implant eroded inside of her. Doctors were unable to remove all the remaining mesh despite three surgeries.
Engleman says she now suffers from chronic vaginal pain and pelvic floor spasms, and has also developed a permanent urinary dysfunction.
“I’m happy I could be a voice for other women,” Engleman said in a statement. “It’s been a nightmare, and I feel justice was truly served today.”
This is the third consecutive eight-figure award against Johnson & Johnson in a mesh case in a Philadelphia courtroom. An Indiana woman received a $12.5 million in a 2015 verdict, and in 2016, a Toms River, New Jersey, woman was awarded $13.5 million.
http://philadelphia.cbslocal.com/2017/04/28/johnson-johnson-jury-verdict/
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Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case
Apr 28, 2017 | FOX 29 News Philadelphia
On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.
The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.
The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.
Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.
She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.
As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.
“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."
The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.
"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.
“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”
Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”
The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.
The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.
http://www.fox29.com/news/local-news/251407273-story
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J&J Hit With $20M Pelvic Mesh Verdict In Philly
Apr 28, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (April 28, 2017, 3:03 PM EDT) -- A Pennsylvania state jury hit Johnson & Johnson on Friday with a $20 million verdict over injuries suffered by a New Jersey woman after receiving a vaginal mesh implant, the third consecutive eight-figure award against Johnson & Johnson in the pelvic mesh mass tort program in Philadelphia County court.
Peggy Engleman was awarded $2.5 million in compensatory damages and $17.5 million in punitive damages after a three-week trial. Engleman claimed that a TVT-Secur medical device manufactured by J&J subsidiary Ethicon was defective and that the companies had failed to warn of its risks. TVT stands for trans-vaginal tape.
Engleman, who filed her lawsuit in 2013, had the device implanted in 2007 to relieve stress urinary incontinence, a condition that caused leakage when she coughed or exercised. But she says the TVT-Secur failed within a month and her condition returned. The mesh then began eroding within her body, and doctors were unable to remove it all even after three more surgeries, she claimed.
The 56-year-old New Jersey resident said she now has chronic vaginal pain, pelvic floor spasms and permanent urinary dysfunction.
“I'm happy I could be a voice for other women,” Engleman said in a statement. “It's been a nightmare, and I feel justice was truly served today."
The TVT-Secur product was launched in September 2006, but Engleman’s attorneys said J&J had received numerous reports of high failure rates from countries all over the world.
"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country — our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," lead plaintiff’s counsel Benjamin Anderson of Cleveland-based Anderson Law Offices said in a statement.
Two previous trials in Philadelphia argued by Shanin Specter of Kline & Specter PC have already resulted in a pair of damage awards against Ethicon totaling some $26 million. A 2015 case produced a $12.5 million verdict for an Indiana woman and a 2016 case led to a $13.5 million for a New Jersey woman.
The pelvic mesh mass tort program still has 183 cases pending, with the next one is scheduled to go to trial on May 8.
"We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition," said Ethicon spokeswoman Kristen Wallace. "We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems. Therefore, we are disappointed with today’s verdict and feel we have strong grounds for appeal."
Engleman is represented by Benjamin Anderson of the Anderson Law Offices, Daniel J. Thornburgh of Aylstock Witkin Kreis & Overholtz PLLC and Chris Gomez of Kline & Specter PC.
J&J is represented by Kenneth A. Murphy, Melissa A. Merk and Andrew P. Reeve of Drinker Biddle & Reath LLP, Nils Burton Snell of Butler Snow LLP, Julie A. Callsen and Rita A. Maimbourg of Tucker Ellis LLP and James M. Campbell of Campbell Campbell Edwards & Conroy PC.
The case is Engleman v. Gynecare et al, case number 140305384, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
--Editing by Brian Baresch.
Update: This article has been updated with more details about the case and a response from Ethicon.https://www.law360.com/articles/918592/breaking-j-j-hit-with-20m-pelvic-mesh-verdict-in-philly
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J&J Hit With $20M Verdict in Third Pelvic Mesh Trial
Apr 28, 2017 | The Legal Intelligencer
By Zack Needles
A 12-member Philadelphia jury handed up a $20 million verdict—including $17.5 million in punitive damages—against Johnson & Johnson subsidiary Ethicon in the third pelvic mesh case to go to trial in the city.
It was also the third multimillion-dollar plaintiff's verdict from Philadelphia's pelvic-mesh mass tort program and the latest in a line of megaverdicts against Johnson & Johnson and its subsidiaries across the country over a variety of products.
The verdict in Ethicon v. Engleman, which also included $2.5 million in compensatory damages, was awarded April 28 in the Philadelphia Court of Common Pleas to a New Jersey woman who alleged she suffered life-altering injuries when the mesh eroded inside of her.
Plaintiff Margaret "Peggy" Engleman, of Cinnaminson, New Jersey, alleged in court papers that she had Ethicon's TVT-Secur mesh implanted to help with her stress urinary incontinence, but her doctor discovered erosions in the material just two months later.
Engleman said in her pretrial memorandum that the eroding mesh began causing her pain and she was eventually forced to undergo three separate surgeries, under anesthesia, to remove the material. However, portions of the mesh remain in her body and she has developed chronic pain and urinary dysfunction, according to the memorandum.
Engleman alleged in court papers that TVT-Secur was "defective in design, warnings and instructions" and that Johnson & Johnson released the product to the public despite knowing that there was a significant risk that the mesh would erode inside patients.
Ethicon argued in its own pretrial memorandum that Engleman offered no evidence that the company "failed to warn of risks not within the common knowledge of pelvic floor surgeons."
"Under New Jersey law, a manufacturer has no duty to warn of risks that are within the common knowledge of physicians," the company said in its memorandum.
But Engleman's attorney, Benjamin Anderson of Anderson Law Offices in Cleveland, said he thought the jury turned in his client's favor when a former consultant for Johnson & Johnson learned for the first time, while being cross-examined, about an internal study circulated within the company warning of the dangers of pelvic mesh.
The jury ultimately agreed with the plaintiffs that TVT-Secur mesh was defective in design and that Ethicon failed to adequately warn of its risks.
According to Anderson, the jury unanimously found that the statute of limitations had not expired; 11 of 12 jurors found the mesh was defectively designed while 10 of 12 found that the design defect caused Engleman's injuries; the failure-to-warn verdict was unanimous, as was the failure-to-warn causation finding; 11 of 12 jurors agreed to the $2.5 million compensatory damages award; 10 of 12 agreed that punitive damages should be awarded and 11 of 12 agreed that to the amount of those damages.
"Their punitive damages award is a reflection, we believe, of how despicable this conduct was, how offensive this was," Anderson said.
An Ethicon spokeswoman said in a statement, “We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems. Therefore, we are disappointed with today’s verdict and feel we have strong grounds for appeal.”
The verdict in Engleman came just over 14 months after a Philadelphia jury unanimously handed up an award of $3.5 million in compensatory damages and $10 million in punitive damages in Carlino v. Ethicon.
Before that, in December 2015, a jury handed up a $12.5 million award to a woman making similar claims about an Ethicon-made pelvic mesh device.
http://www.thelegalintelligencer.com/id=1202784879435/JJ-Hit-With-20M-Verdict-in-Third-Pelvic-Mesh-Trial?mcode=0&curindex=0&curpage=2
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*New** J&J Hit With $20 M Verdict in 3rd Philadelphia Pelvic Mesh Trial
Apr 28, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, April 28, 2017 ~ In the last 15 months J&J and its Ethicon medical device division has accrued $34.5 million in punitive damages over its transvaginal meshes.Another 200 cases await trial in this Philadelphia courtroom and hundreds are poised in a Bergen, New Jersey court ready for trial.
**This story has been updated Saturday*
The three-week transvaginal mesh trial of Engleman v. Ethicon (140305384) concluded in a Philadelphia court Friday afternoon with a $20 verdict for Ms. Peggy Engleman, 56 of Cinnaminson, PA.
The jury awarded $2.5 million in compensatory damages for the complications she suffered from the TVT-Secur transvaginal tape used to treat incontinence after being implanted in 2007.
Jurors also hit Ethicon with $17.5 million in punitive damages, the highest amount of punitive damages awarded so far among the transvaginal mesh cases heard in this court.
Jurors decided TVT-Secur was defectively designed and the instructions were inadequate and the device maker failed to warn the doctors and patients about its potential dangers.
The TVT-Secur (TVT-S) is a polypropylene mesh “hammock” that cradles the urethra to treat incontinence. It is tethered in place with two arms that extend up through the buttocks.
TVT-S was cleared for market in 2006 without any clinical trials through the U.S. Food and Drug Administration’s 510(k) clearance process.
It was removed from the market voluntarily by J&J in mid-2012 along with three other problematic pelvic meshes. The company said it was for financial reasons. See MND story here.
Engleman v. Ethicon began April 10 before Judge Ann Butchart of the Philadelphia Court of Common Pleas. It was the first transvaginal mesh trial in this court in 14 months.
Ms. Engleman was represented by Christopher Gomez of Kline Specter, Ben Anderson of Anderson Law and Bryan Aylstock of Aylstock Witkin Kreiz and Overholtz.
Representing Johnson & Johnson/ Ethicon was Jim Campbell, Rita Maimbourg and Burt Snell of Butler Snow.
This is the third in a series of Johnson & Johnson losses in the Philadelphia Court of Common Pleas.
In the previous cases, Hammons and Carlino, heard in the same court in December 2015 and February 2016, delivered a $12.5 million verdict and $13.5 million to the plaintiffs, respectively, which included $17 million in punitive damages.
With today’s verdict, J&J is facing $34.5 million in punitive damages from three transvaginal mesh trials recently heard in this court.
Testimony for the plaintiff included Dr. Bruce Rosenzweig, who told jurors that polypropylene mesh will degrade, fray and lose particles. It can cause chronic foreign body reactions, fibotic ridging, mesh contracture/shrinkage and loss of pore size with tension.
Dr. Rosenzweig, a urogynecologist from Rush University in Chicago, has been an expert in a number of previous transvaginal mesh trials.
No information was included in this case about the role the Food and Drug Administration plays in clearing transvaginal mesh for market through the fast-track 510(k) approval process.
The Philadelphia Court has nearly 200 transvaginal mesh cases waiting to heard primarily naming defendants Johnson & Johnson and Boston Scientific.
There are 102,000 product liability lawsuits consolidated in federal court in Charleston, West Virginia naming six defendant mesh makers, J&J and Boston Scientific among them.
DETAILS ABOUT THE TRIAL
Ben Anderson tells Mesh News Desk that the jury was made up of four men and eight women of varying ages. There were two Caucasians, an Asian and the rest were African-American.
After experiencing incontinence, Ms. Engleman received the TVT-S in 2007 but within one month she reportedly had a return of her condition. She also began experiencing pain and discomfort when her mesh device eroded into her vagina.
Doctors were unable to remove the TVT-S during the three surgeries she endured.
Today, she still has urinary dysfunction, pelvic floor spasms and vaginal pain.CBS News (here) quoted Engleman as saying, “I’m happy I could be a voice for other women, It’s been a nightmare, and I feel justice was truly served today.” *New** J&J Hit With $20 M Verdict in 3rd Philadelphia Pelvic Mesh Trial
Mesh Medical Device News Desk, April 28, 2017 ~ In the last 15 months J&J and its Ethicon medical device division has accrued $34.5 million in punitive damages over its transvaginal meshes.
Another 200 cases await trial in this Philadelphia courtroom and hundreds are poised in a Bergen, New Jersey court ready for trial.**This story has been updated Saturday*
The three-week transvaginal mesh trial of Engleman v. Ethicon (140305384) concluded in a Philadelphia court Friday afternoon with a $20 verdict for Ms. Peggy Engleman, 56 of Cinnaminson, PA.
The jury awarded $2.5 million in compensatory damages for the complications she suffered from the TVT-Secur transvaginal tape used to treat incontinence after being implanted in 2007.
Jurors also hit Ethicon with $17.5 million in punitive damages, the highest amount of punitive damages awarded so far among the transvaginal mesh cases heard in this court.
Philadelphia Court of Common Pleas
Jurors decided TVT-Secur was defectively designed and the instructions were inadequate and the device maker failed to warn the doctors and patients about its potential dangers.
The TVT-Secur (TVT-S) is a polypropylene mesh “hammock” that cradles the urethra to treat incontinence. It is tethered in place with two arms that extend up through the buttocks.
TVT-S was cleared for market in 2006 without any clinical trials through the U.S. Food and Drug Administration’s 510(k) clearance process.
It was removed from the market voluntarily by J&J in mid-2012 along with three other problematic pelvic meshes. The company said it was for financial reasons. See MND story here.
Engleman v. Ethicon began April 10 before Judge Ann Butchart of the Philadelphia Court of Common Pleas. It was the first transvaginal mesh trial in this court in 14 months.
Chris Gomez, Kline Specter
Ms. Engleman was represented by Christopher Gomez of Kline Specter, Ben Anderson of Anderson Law and Bryan Aylstock of Aylstock Witkin Kreiz and Overholtz.
Representing Johnson & Johnson/ Ethicon was Jim Campbell, Rita Maimbourg and Burt Snell of Butler Snow.
This is the third in a series of Johnson & Johnson losses in the Philadelphia Court of Common Pleas.
In the previous cases, Hammons and Carlino, heard in the same court in December 2015 and February 2016, delivered a $12.5 million verdict and $13.5 million to the plaintiffs, respectively, which included $17 million in punitive damages.
With today’s verdict, J&J is facing $34.5 million in punitive damages from three transvaginal mesh trials recently heard in this court.
Bruce Rosemzweog. MD, Expert for Plaintiff
Testimony for the plaintiff included Dr. Bruce Rosenzweig, who told jurors that polypropylene mesh will degrade, fray and lose particles. It can cause chronic foreign body reactions, fibotic ridging, mesh contracture/shrinkage and loss of pore size with tension.
Dr. Rosenzweig, a urogynecologist from Rush University in Chicago, has been an expert in a number of previous transvaginal mesh trials.
No information was included in this case about the role the Food and Drug Administration plays in clearing transvaginal mesh for market through the fast-track 510(k) approval process.
The Philadelphia Court has nearly 200 transvaginal mesh cases waiting to heard primarily naming defendants Johnson & Johnson and Boston Scientific.
There are 102,000 product liability lawsuits consolidated in federal court in Charleston, West Virginia naming six defendant mesh makers, J&J and Boston Scientific among them.
DETAILS ABOUT THE TRIAL
Ben Anderson tells Mesh News Desk that the jury was made up of four men and eight women of varying ages. There were two Caucasians, an Asian and the rest were African-American.
After experiencing incontinence, Ms. Engleman received the TVT-S in 2007 but within one month she reportedly had a return of her condition. She also began experiencing pain and discomfort when her mesh device eroded into her vagina.
Doctors were unable to remove the TVT-S during the three surgeries she endured.
Today, she still has urinary dysfunction, pelvic floor spasms and vaginal pain.CBS News (here) quoted Engleman as saying, “I’m happy I could be a voice for other women, It’s been a nightmare, and I feel justice was truly served today.”
Testimony at trial revealed TVT-Secur was tested on live sheep and dead sheep, cadavers and 31 women for five weeks before it was rushed to market.
Trying to improve on TVT (tension-free tape) the TVT-S is considered a mini-tape since it is shorter than a typical incontinence device. Anderson says it was completely different because it came with fleece tips like velcro that had never been used before and arrowhead introducers. The polypropylene mesh material is heavy weight and small pore.
Ethicon’s own documents were the most powerful. It said “Our cardinal sin was to rush to market without sufficient clinical data.”
Ms. Engleman’s ob-gyn and urogynecologist both blamed her injuries on the TVT-S. TVT-S and three other
70% FAILURE RATE
Some of the most damaging testimony came from the Ethicon consultant Dr. Haab who wrote in an article “Promises Made-Promises Broken” (here) that the failure rate of TVT-S was 70%.
Dr. Haab was a consultant for Gynecare, the women’s health division of Johnson & Johnson.
In that study almost 40% of the women participating suffered serious adverse events with the device. Ethicon/ J&J never published the study.
When J&J preceptor Brian Flynn was asked if J&J ever shared the data, he said No.
Anderson asked, “Was it important?” “Yes.”
The report said the TVT-Secur cannot be recommended for a first-line treatment.”
Anderson asked Flynn, “Did they share this with you?” “No.” Was it important? “Yes.”
Anderson tells MND that Flynn appeared shocked. Sitting on the stand before the jury was a watershed movement when he first learned about the existence of this document.
Anderson pointed to an empty chair during his closing arguments pointing out that the company, though only 100 miles away, failed to put a single representative on the stand to defend their product. He pointed to the empty chair during the closing.
“When the jury saw the amount of information on serious health risks to women that existed before it was ever launched, they decided there was clear and convincing evidence that Ethicon and Johnson & Johnson maliciously and with wanton disregard for women put this device on the market, that they put profits before people and they deserved to be punished,” said Anderson.
http://www.meshmedicaldevicenewsdesk.com/14521-2/
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Vaginal mesh implant victim to be paid $20mn by Johnson & Johnson, PA jury orders
Apr 29, 2017 | RT
A state court jury has ordered Johnson & Johnson to pay $20 million verdict to a New Jersey woman who suffered injuries from an implanted vaginal mesh device. The company is currently being sued.
On Friday, a Philadelphia Common Pleas Court jury awarded $2.5 million in compensatory damages and $17.5 million in punitive damages to Peggy Engleman, 56, after lawyers argued that not only was the TVT-Secur mesh defective, but Johnson & Johnson and its Ethicon subsidiary concealed the risks that they were aware of during the marketing of the product.
“I’m happy I could be a voice for other women,” Engleman said in a statement. “It’s been a nightmare, and I feel justice was truly served today.”
Engleman had the TVT-Secur medical device implanted in 2007 to relieve stress urinary incontinence. However, the device failed within a month and her condition returned. Attorneys argued that Engleman began experiencing pain when the polypropylene mesh from the implant eroded inside her.
Engleman claims she now suffers from chronic pain and spasms and has developed a permanent urinary dysfunction. Engleman also said the device caused “sharp stabbing pain” and bladder problems. She underwent three surgeries to remove the mesh, but doctors were unable to remove the device that still remains in her abdomen.
Benjamin Anderson, the lead counsel to Engleman, said the company put “profits before safety” when they ignored numerous complaints and reports of high failure rates from all over the world.
“The jury spoke, and they sent a message that J&J and Ethicon need to take responsibility,” Chris Gomez an attorney from one of the law firms representing Engleman, said, according to the Philadelphia Inquirer.
Kristen Wallace, a spokesperson for Ethicon, the unit that sells the device denied that the product or the company were at fault.
“We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems,” Wallace said, according to an emailed statement obtained by Bloomberg.
Johnson & Johnson is facing three more trials in Philadelphia over the next two months. The company lost two earlier cases involving defective pelvic mesh devices in Philadelphia resulting in awards of $12.5 million and $13.5 million.
https://www.rt.com/usa/386534-johnson-philadelphia-mesh-verdict/
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Caz Chisholm recognised for campaign supporting women pelvic mesh victims
May 1, 2017 | Newcastle Herald
By Joanne McCarthy
A WOMAN who launched a campaign to support women victims of pelvic mesh and hold Australian health regulators to account has won two awards for consumer health advocacy.
Australian Pelvic Mesh Support Group founder Caz Chisholm received the Western Australian Health Consumers Council health consumers award and the Rosemary Caithness Award for outstanding service to health consumers after a campaign, supported by the Newcastle Herald, for a Senate inquiry into pelvic mesh.
Ms Chisholm’s group jumped from 39 members in early 2015 to more than 600 by Thursday when she received the awards, only days before International Mesh Awareness Day on Monday, May 1. The day was initiated by mesh support groups in countries including Australia, America, New Zealand, Great Britain and European countries including the Netherlands. In America alone more than 125,000 women have initiated legal action against mesh manufacturers after they were implanted with transvaginal mesh (surgery through the vagina rather than the abdomen) after post-childbirth complications.
An American woman on Friday was awarded $20 million compensation for complications after mesh surgery in 2007 using a Johnson & Johnson transvaginal mesh. In Australia 450 women have joined a class action against Johnson & Johnson, another 350 women have joined a class action against a second American device manufacturer, and more than 1000 women in total have complained of serious injuries after mesh surgery.
Ms Chisholm said she was “thrilled and honored to receive these awards as this represents the acknowledgement of all women suffering from the devastating effects of mesh”.
“What we seek first and foremost is recognition of our pain and suffering because most of us have been ignored by doctors, and when we do present with complications we are told they are caused by anything other than mesh,” Ms Chisholm said.
“Yet when women join the support group and they read about the same complications as others, they breathe a sign of relief and often cry because finally they have the recognition that they are not imagining their pain and they are not going crazy.
“They realise their pain is real and their pain is from mesh.”
Western Australian Health Consumers Council executive director Pip Brennan said Ms Chisholm’s double win of the two most prestigious consumer health awards recognised her tireless advocacy for mesh victims and outstanding work on giving them a voice.
“The use of mesh is now the subject of a federal Senate inquiry, which is taking submissions until May 31, and the inquiry’s title is ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. This highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications,” Ms Brennan said.
“Caz Chisholm has spent significant time and energy raising awareness for women about the issue and providing essential peer support. She was also directly responsible for ensuring that the Senate inquiry was successfully advocated by Senator Derryn Hinch.”
In 2016 Australia’s peak health regulator for medical devices, the Therapeutic Goods Administration, quietly placed on its website a list of at least 30 known complications following pelvic mesh surgery, after TGA executives met with Ms Chisholm and other support group members.
The complications include punctures of vessels, nerves, structures or organs including the bladder, urethra or bowel; foreign body response including erosion of mesh into the vagina, bladder or bowel; chronic infections; acute or chronic pain; pain during intercourse; temporary or permanent inability to void via the lower urinary tract; bleeding; chronic pain in the groin, thigh, leg or abdomen; atypical vaginal discharge; exposed mesh may cause pain to the patient’s partner during intercourse and abscess.
http://www.theherald.com.au/story/4630376/mesh-campaigner-wins-awards/
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Mesh Implant ‘Guinea Pig’ Suing NHS Tayside For £100,000
May 1, 2017 | Evening Telegraph
By Will Lyon
The first woman to have a mesh implant fitted at Ninewells Hospital has launched a £100,000 compensation case against NHS Tayside.
Yvonne Cleary, 57, was in her forties when she underwent controversial treatment to treat a mild case of pelvic organ prolapse.
But following the operation at Ninewells, she was left in constant pain and now she has joined more than 800 women around the country suing the NHS and manufacturers of the implants.
Yvonne’s mesh became infected and she was brought back into hospital to have it removed, but by then it had become embedded in her body.
The Ardler grandmother said she can’t believe it has taken so long for the legal process to begin.
The retired factory worker said: “At the time I had the operation there was no warning or anything about the products they were using.
“But now I think this legal action has been made easier after loads of Americans won cases — I think some of them received about £1.4 million.
“My solicitors reckon I’ll get about £100,000 if it’s successful.
“It’s terrible it has taken this long and they reckon it’s going to be another year to two years for this to settle. I was the first person in the city to have the implant. I was Dundee’s guinea pig for this treatment and they have no idea the pain I’ve been through.
“I wish this could have happened earlier but solicitors weren’t interested when I told them about this years ago.
“If something had been done then, so many other women out there could have avoided what I’ve been through.”
Yvonne says she still feels the effects of what happened to her, more than a decade later.
She said: “I’m stressed out. My life has been a recurring nightmare ever since the implant was fitted. It ruined my life.
“I lost my partner, I lost my home and now I’m at the foodbanks because the government has taken my Employment and Support Allowance away.
“They say I’m now fit to work but I’m not. The people down there don’t see me on my bad days.
“I’m still in pain and I’m angry. It feels like my body wants to shut down.”
An NHS Tayside spokeswoman said it would be inappropriate to comment as it is a legal matter.
https://www.eveningtelegraph.co.uk/fp/mesh-implant-guinea-pig-suing-nhs-tayside-100000/
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May Flowers and Mesh Friendships
Apr 30, 2017 | Mesh Medical Device Newsdesk
By Jane akre
Mesh Medical Device News Desk, May 1, 2017 ~ Hello to everyone. I hope this May finds you in a hopeful mood and regaining your health.
If not, I certainly hope you can connect with the mesh community that seems to be springing up all over the Internet!
Please reach out to others who may need a helping hand, a reference or just a shoulder to cry on.
I just returned from the Johnson & Johnson annual shareholder’s meeting, where many campaigners took to the street outside the State Theater to let shareholders and CEO Alex Gorsky know their true profit is only known when they acknowledge the harm that’s been done.
A very rehearsed presentation ensued electing the 10 members of the Board of Directors amid a rally about the health of the J&J stock. I was struck by the words “sustainable” and “people come first” as part of the company’s credo, repeated by the CEO. How did that square with the people across the street?
About 30 women and their families protested J&J in an orderly, heart-felt, display, complete with signs and chanting. These are the women who could make it here, I thought. Each one represents at least 10,000 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!
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. Especially a permanent implant.
Mesh Medical Device News Desk has been reporting on the issues for five years now and the calls are only growing. So are the cases. There are now 102,000 product liability cases filed in one West Virginia court, consolidated in multidistrict litigation. Another 10,000 are filed around the country.
Also increasing is the media coverage. Internationally, the media is less afraid to report of Pharmaceutical Giants, so we see front page stories in Scotland, Australia, New Zealand and the UK.
Here in the U.S. a flashing screen inside the meeting of all of the J&J products, from Benadryl, Aveeno, Neutrogena, Imodium, Roc, Baby products, the list goes on and on. Someone sitting nearby said no wonder we don’t hear about the problems in this country.
If you have been injured by mesh, please visit these pages, Use the Search Bar to find out more about your manufacturer. Understand the issues, speak to your doctors and lawyers. And insist they speak to you!
If mesh has been suggested to you, ask if the doctor can do a non-mesh repair. Are you a candidate? A doctor without those skills might not be your first choice. Be an informed consumer, something you may have to do for yourself, since so many doctors remain in the dark about polypropylene mesh and its potential complications.
As I was leaving the shareholder’s meeting, a man standing next to Mr. Gorsky asked me if I had a question. Gorsky had just turned away and I didn’t get to speak to him. I noted this suited man’s name tag said Executive VP and General Counsel. Perfect, I thought.
My one question was since Mr. Gorsky had insisted the company was about sustainability, is the present situation of fighting mesh- injured women in court sustainable, since the company had lost so many cases so far? Might a multi-billion dollar global settlement be in the works?
He looked at me as though I had grown two heads, and suddenly turned his shoulder while muttering something about not discussing litigation. In a flash he was gone.
Little did I know that at that same hour, 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!
That meant among three trials in one Philadelphia courtroom, J&J was facing $34.5 million in punitive damages alone.
Can any company say those record losses represent sustainability?
Take care of yourself and take care of each other, and carry on!
Your editor,
Jane akre
http://www.meshmedicaldevicenewsdesk.com/may-flowers-mesh-friendships/
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Women Suing Over Vaginal Mesh Complications Say Doctors Didn’t Inform Them Of Risks
Apr 28, 2017 | Verily
By Katie Faley
Many women are taking a stand against a controversial health issue that is causing some serious damage. Though many doctors have claimed that vaginal mesh devices are harmless and easy procedures, women who have had the surgery are experiencing side effects that are anything but harmless. Vaginal mesh is a net-like implant often used to treat incontinence and prolapse, which are common results of pregnancy. After the results of the operation left some women permanently harmed and maimed, one woman set up a support page on Facebook called “Sling the Mesh.”
Karen Sansom realized that there are many women who are told that the vaginal mesh procedure is low-risk; now many are suing after experiencing harmful side effects they were never informed of. Sansom said that after her vaginal mesh procedure, she knew something was seriously wrong when she had intense foot and leg pain along with burning pains in the vaginal area. When she went to see her surgeon, he dismissed her concerns and told that it was probably due to a slipped disk. According to her article, Sansom writes, “The NHS and MHRA say the risk of complications with these operations is one to three percent but a report in the journal Nature by nine leading medics puts that risk at 15 percent.” She is now suing over the complications she says she was never informed of. Other women have experienced leg amputation, removal of bowels and bladder, and constant burning infections as a result of the operation.
As with other areas of women’s health where patients say doctors gloss over the risks, as Dr. John Littell has written for Verily on the topics of prescribed birth control and miscarriage prevention, this is a topic that needs urgent attention.
http://verilymag.com/2017/04/wywo-music-celebrity-news-feminine-health-grief
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Thousands of women sue Bayer over medical issues using Bayer's Essure
Apr 28, 2017 | Modern Healthcare
By Elizabeth Whitman
Drug and devicemakers must weigh the impact of litigation and public relations battle when allegations of patient harm arise
After giving birth to her third daughter in 2013, Rina Kellogg was done having children. She wanted to have her tubes tied, but her OB-GYN suggested she get a sterilization implant called Essure.
"She said it was the latest and greatest technology, and that it was like putting a stent in your heart," said Kellogg, a 36-year-old living in Spring, Texas. "I trusted her and I went ahead and did the procedure."
Essure consists of two sets of tiny coils-one of stainless steel, wound with polyethylene terephthalate polyester fibers, nestled in a larger nickel-titanium coil-that are implanted in a woman's fallopian tubes. Scar tissue is supposed to form around them, securing the coils and blocking the tubes so that eggs cannot be fertilized.
After the implantation in August 2014, Kellogg was in pain. But she assumed her body needed time to adjust. By Christmas, however, she was in agony with cramping and profuse bleeding. During a follow-up visit, Kellogg's doctor dismissed her symptoms as results of stopping hormonal birth control. She also told Kellogg, 33 at the time, that she was "getting older."
The bleeding lasted for more than a year. At 34, Kellogg had a hysterectomy to remove the device. Still, her medical problems persisted. Since 2013, she has been diagnosed with chronic fatigue, irritable bowel syndrome, fibromyalgia, insomnia and other medical issues-a far cry from when she worked 50-hour weeks as a special-education teacher, all while pregnant with her second child."I literally went from having no medical problems before this, to bleeding for about 424 days, to having a hysterectomy as a young mother with three kids," Kellogg said. "I'm still having issues, even though I got it out."
Kellogg is among a legion of women who are speaking up about severe medical problems they say were triggered by Essure. In recent years, thousands of women alleging harm from Essure have filed lawsuits against Bayer, the device's manufacturer.
Some experts and physicians predict that these efforts will drive Essure off the market, not necessarily because it's deemed unsafe, but because it will no longer be marketable. In the past, other device and drugmakers have done just that after lawsuits, settlements and Food and Drug Administration safety warnings—not formal recalls—made the products a bigger liability than they were worth. Until companies draw that line, patients still face risks.
"I'll be surprised if Essure is being sold 15 months from now," said Erik Gordon, a professor at the Ross School of Business at the University of Michigan. "If Bayer doesn't pull it, I think the FDA will."
Essure was developed in the 1990s by California-based company Conceptus, which Germany-based Bayer acquired in 2013. Between Nov. 4, 2002, when the FDA approved Essure, and Dec. 31, 2016, the FDA received 14,919 reports documenting device migration, organ perforation, severe pain and a slew of other adverse reactions.
In 2016, the FDA mandated a black box warning, the highest-level alert, for Essure. Patients and their advocates continue to call for it to be taken off the U.S. market, as Brazil did in February, when it suspended the importation, distribution and marketing of Essure.
Last year, impairment losses connected to Essure cost Bayer $413 million, according to the company's 2016 annual report. The company expects it will face even more lawsuits.
When asked whether it was considering pulling the device from the market, Bayer said it "stands behind Essure and its positive benefit-risk profile."
"The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-incisional procedure, are supported by more than a decade of science as well as real-world clinical experience," according to Bayer.
But if Bayer does stop marketing the device, it would not be unprecedented. Other companies have withdrawn medical devices from the market voluntarily in the past without the FDA issuing a recall.
In 2014, Johnson & Johnson pulled three types of power morcellators, which are used to extract fibroid tumors, after they were found to have a high risk of spreading cancer. Those devices constituted a small portion of its revenue.
The FDA did not ban or recall the morcellators, but it sent a safety advisory to doctors warning them not to use the devices for uterine fibroids. After that notice went out, J&J pulled them off the market.
"J&J could've kept selling it," Gordon said, referring to the morcellators.
In other cases, J&J stopped selling Pinnacle hip devices in 2013, the same year it paid $2.5 billion to compensate patients over a different product, ASR hip devices. In 2012, its Ethicon division stopped selling mesh urinary implants, over which women had filed thousands of lawsuits against the company alleging harm. The following year, a jury ordered J&J to pay $3.35 million to a woman because the company did not adequately warn her doctor about the implant's potential risks.
Last October, St. Jude Medical recalled nearly 400,000 defibrillators, whose batteries could fail unexpectedly. The FDA recently warned that the company had nevertheless somehow allowed seven patients to be implanted with them, even after the recall. One stock analyst said that could serve as a PR "black eye" for Abbott, which acquired St. Jude in January, the Minneapolis Star Tribune reported.
Costly litigation, settlements and negative publicity are a few precipitating factors that can push a company over the tipping point to pull a device.
"For the company, it's more of a business decision," Gordon said. "At some point, your risk management people look at it and say it's just too financially risky to keep selling these things."
Bayer said it has sold 750,000 Essure devices since 2002, the majority of them in the U.S. It does not release annual sales figures, but the 750,000 figure hasn't changed for at least four years. In a 2013 filing to the Securities and Exchange Commission, Conceptus said it had distributed that same number of Essure devices.
Data from the ECRI Institute, a Philadelphia-based not-for-profit that researches patient safety issues, suggest that some providers are abandoning Essure. In 2014, 365 members of ECRI's PriceGuide service spent $8.34 million to purchase 4,836 Essure devices. In 2015, 299 members spent $5.79 million on 3,244 devices. The following year, the numbers fell further, with 180 members spending $1.98 million on 1,122 devices.
The data have a few important limitations. The majority of PriceGuide members are hospitals and surgical centers. The numbers do not necessarily include purchases by physicians. They also cover only a span of three years, and so it's not clear whether the decline is the continuation of sales trends prior to 2014 or whether it represents a change.
Still, physician feedback corroborates the diminished interest in Essure indicated by those declining sales, regardless of prior trends.
In February, Modern Healthcare polled OB-GYNs about Essure through Sermo, an online social network for doctors. Of the 387 OB-GYNs surveyed, 272 said they had implanted Essure devices in patients. Of those doctors, 175, or 64%, said that their Essure implants per year in the past five years had declined significantly; 42 doctors, or 15%, said the implants had declined a little.
"In the end, the doctors are the biggest gatekeepers," Gordon said. If patients tell physicians that they don't want a device or drug, then physicians, fearing malpractice suits, begin to abandon it, he explained. If sales fall, then the company loses its incentive to keep selling the device, especially if it's increasingly connected with lawsuits and negative attention.
In anonymous comments submitted with the Sermo poll, OB-GYNs in the U.S. offered a mix of opinions. "Essure provides a form of permanent sterilization that is particularly helpful for patients who are not good candidates for abdominal surgery," one said. "However, since reversible options . . . are equally effective, I will be monitoring the risk-benefit profile of Essure closely."
Another said that when the procedure goes well, Essure was "a great method of sterilization," but "when things don't go well (there) can be significant issues trying to remove the implants."
Several said they had stopped offering Essure or significantly scaled back due to side effects.
One OB-GYN weighed in on the "paranoia" around Essure, calling it "one of the worst issues I deal with" and saying it had caused the doctor to perform many more unnecessary laparoscopies.
Amanda Yunker, an assistant professor of obstetrics and gynecology at Vanderbilt University School of Medicine in Nashville, said she has seen "a steady increase" in the number of patients seeking removal in the past few years. She estimated she has removed 80 to 100 Essure devices, none of which she implanted.
Yunker's practice is centered around pelvic pain, and she has noticed that such pain is a common symptom after patients had Essure implanted. "You're never 100% sure, because pain is very subjective and it's multifactorial. There could be a lot of things that contribute to pelvic pain," Yunker said. Nevertheless, "the majority of them definitely had improvement in their pain when it (Essure) was removed," she said.
No medical device or drug is perfectly safe. The fundamental challenge with Essure is knowing which patients are apt to do well with it and which are prone to severe, even debilitating complications. The FDA's position is that those in the former category should have access to the device, even while those who fall in the latter are protected.
"The unfortunate thing is, we don't know where people fall prior to implanting the device," Yunker said.
Many studies focusing on Essure have compared aspects of the procedure, such as methods of pain management or follow-up testing. They have not sought to find relationships between a patient's medical profile prior to the procedure and her outcomes afterward.
According to a systematic review of Essure by researchers in Finland and published in the journal Fertility and Sterility in 2010, long-term data on Essure's safety and efficacy were still unavailable, and there were no randomized controlled studies of the device. The researchers also noted that most studies on Essure have been funded by Bayer.
The FDA has required Bayer to conduct a new study of Essure's benefits and risks that it hopes will shed light on the complications that afflict women who have Essure, compared to those who have tubal ligation.
Essure patients, especially women who are part of the Facebook group Essure Problems, and their advocates argue that the only way to prevent further harm is to remove the device from the market entirely.
But the FDA maintains that the device is safe for a majority of women and that pulling the device would deprive them of an important birth-control option. It also says that the required black box warning does enough to protect patients.
"After significant review and analysis of available information, we believe Essure is safe and effective for many women-but also that some women experience very serious and sometimes debilitating problems," said Deborah Kotz, an FDA spokeswoman.
Meanwhile, the more than 14,000 reports to the agency have "not changed the FDA's determination regarding the benefits and risks of Essure," Kotz said. Essure offers benefits despite these side effects, she added, noting that it is currently the only non-incisional form of permanent birth control.
Kotz said that the updated labeling "helps to ensure that patients are appropriately informed of the risks" from Essure. "Banning Essure would remove the device from the market for all patients-and would limit the options available to physicians and patients." Natalie Hansen, a 47-year-old living in Mooresville, N.C., and a former Essure patient, is skeptical of that approach.
Before she was implanted with Essure in 2011, Hansen recalled, her doctor dismissed her queries about the risk of an allergic reaction to nickel, which Hansen knew even then that she was sensitive to. And since then, she has made more than 70 doctor's visits and endured searing pain, depression, cysts, severe bloating, autoimmune symptoms and a host of other medical problems. Yet she considers herself lucky.
In early April, she had a hysterectomy, and with it, her pain and complications have disappeared-almost miraculously. Her sense of humor, dampened for years by the constant pain, has resurfaced. "Despite having organs taken out, I haven't felt this good in years," she said.
Hansen said that doctors today are fully aware of the risks of Essure, even after the black box warning the FDA issued in 2016. "Who's holding them accountable to make sure they're actually giving this information to patients?" she asked.http://www.modernhealthcare.com/article/20170429/MAGAZINE/170429836
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