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ethicon 10/6
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AMS Pelvic Mesh Lawsuits Settled and Dismissed by the Hundreds
Jun 9, 2016 | Mesh Medical Device News Desk
Six hundred pelvic mesh lawsuits dismissed in one work week. Unlike the snail pace of federal pelvic mesh litigation,Mesh News Desk has learned that over the last work week, 673 product liability lawsuits concerning pelvic mesh made by American Medical Systems (AMS) have been settled and dismissed. -
Ethicon Physiomesh Flexible Composite Mesh
Jun 9, 2016 | Australian Government Department of Health
Hazard alert - higher rate of recurrence/reoperation9 June 2016 Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, is issuing a hazard alert for Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Johnson & Johnson Medical is also recalling all unused stock of these devices (all product codes and all lots). -
Gynaecologists voice concern over surgical mesh in women causing harm
Jun 10, 2016 | One News Now
By Lorelei Mason
There's concern doctors may have leapt in too quickly to use surgical mesh on women patients without waiting for proof it was safe. That's the claim from some of the country's leading gynaecologists in the wake of a Health Select Committee report suggesting changes to reduce the harm caused to hundreds of patients through mesh use. -
Doubly Traumatized: Pelvic Mesh & the Sexual Abuse Survivor
Jun 9, 2016 | Pelvic Mesh Owners Guide
Two things happened this past week that make it imperative to write about the connection between two traumas: sexual abuse and pelvic mesh injury.
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Online Sources
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AMS Pelvic Mesh Lawsuits Settled and Dismissed by the Hundreds
Jun 9, 2016 | Mesh Medical Device News Desk
Six hundred pelvic mesh lawsuits dismissed in one work week.
Unlike the snail pace of federal pelvic mesh litigation,Mesh News Desk has learned that over the last work week, 673 product liability lawsuits concerning pelvic mesh made by American Medical Systems (AMS) have been settled and dismissed.
According to the language in the dismissal notices, the cases have been resolved or settled for an unknown amount, though women reporting to Mesh News Desksay their settlements range from $9,000 to approximately $200,000.
After legal fees of approximately 33.3% to 40% are subtracted, along with any loans, hospital, doctor bills, the settlement amount is reduced by about half.
Judge Joseph Goodwin
Hundreds of cases have been dismissed byJudge Joseph Goodwin, overseeing multidistrict litigation (MDL) in Charleston, WV or by joint motion filed by plaintiff and defendant law firms.
“..they have compromised and settled all claims between them in these actions, including all counterclaims, cross-claims and third party claims.”
In some of the lawsuits, AMS is the only defendant in the listed actions. See # Doc 2359, June 2, 2016, dismissing 42 cases. Dismissing a case with prejudice means it cannot be refiled in the future.
In other cases where the woman received more than one pelvic mesh, the AMS claim will be removed from its docket but the action will remain active on the docket for Boston Scientific, Ethicon (Johnson & Johnson), or C.R. Bard, the other major mesh manufacturers.
See Doc # 2358, June 2, 2016, transferring cases overseen by Clark, Love and Hutson to Boston Scientific.
Since the first of May, there have been more than 50 other Petitions to dismiss, which presumably contain hundreds of other AMS lawsuits that have settled.
As of today, AMS is still listed as having 20,199 active cases on the docket in the MDL. The company never had a bellwether trial to test legal theories before settlement talks began.
Judge Goodwin encouraged other mesh makers to follow the lead of AMS settlements, but so far, none have done so.
AMS urology products was purchased in April 2011 by Endo International PLC, with headquarters in Dublin, Ireland. Timing was everything.
The purchase occurred on the eve of a tsunami of pelvic mesh lawsuits. So many so thatmultidistrict litigation (MDL) to consolidate cases was formed in January 2012 and has swelled to 93,000 lawsuits filed against seven manufacturers, AMS among them.
AMS/ENDO SETTLEMENTS TO DATE
Monarc by AMS for SUI
In April 2014, AMS/Endo agreed to an $830 million settlement fund to resolve about 20,000 claims. One year earlier, AMS/Endoannounced a $54.5 million settlement to resolve pelvic mesh lawsuits.
In September 2014, AMS/Endo announced a master settlement of $1.6 billion to resolve the lawsuits facing AMS.
At the time it was reported that Endo put AMS on the auction block. Valued at $2 billion, Endo purchased AMS’s urology products for $2.9 billion in 2011. See the story here.
In March 2015, Endo International announced it sold the urology division to Boston Scientific for up to $1.65 billion. The women’s health division was renamed as Astora Women’s Health device unit and put on the market but there were no buyers.
Astora Women’s Health was closed by Endo in March due to litigation costs. The Wall Street Journal reported on the closure here.
Astora Women’s Health announced as of March 31 it had suspended all commercial activity and is no longer making or distributing any women’s health products.POP mesh, Elevate by AMS
AMS made the Apogee and Perigee Systems,ElevateTM Anterior and Posterior Pelvic Floor Repair System and IntePro Y sling to treat pelvic organ prolapse. The MiniArc, RetroArc, Monarc, In-Fast, BioArc and SPARC slings all treat stress urinary incontinence.
Since it took Apogee off the market, AMS no longer has to conduct FDA mandated three years of post approval monitoring on those models of pelvic mesh products.
http://www.meshmedicaldevicenewsdesk.com/ams-pelvic-mesh-lawsuits-dismissed-hundreds/
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Ethicon Physiomesh Flexible Composite Mesh
Jun 9, 2016 | Australian Government Department of Health
Hazard alert - higher rate of recurrence/reoperation9 June 2016Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, is issuing a hazard alert for Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Johnson & Johnson Medical is also recalling all unused stock of these devices (all product codes and all lots).
Ethicon Physiomesh Flexible Composite Mesh is an implanted medical device that can be used in laparoscopicoperations to repair ventral hernias and other fascial issues requiring a reinforcing or bridging material.
Analysis of unpublished data from two large independent overseas hernia registries (Germany and Denmark) has shown that laparoscopic ventral hernia repair using Ethicon Physiomesh Flexible Composite Mesh has a higher rate of recurrence/reoperation compared to the average rates of other similar products among patients in these registries.
The factors causing this increased rate cannot be fully determined at this time, but are believed to be multifactorial.
Based on this, a decision has been made to withdraw the device from the global market and provide what information is available to health professionals to assist in the management of affected patients.
Please note that this issue only affects Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). It does not affect Ethicon Physiomesh Open Flexible Composite Mesh or other hernia or urogynaecological mesh products.Information for consumers
If you have had laparoscopic surgery to treat a ventral hernia using a mesh and you experience any signs or symptoms of recurrence of the hernia, talk to your health professional. They may refer you to your surgeon or to the hospital where the surgery was undertaken.
If you have any other questions or concerns about this issue, talk to your health professional.Information for all health professionals
If you are treating a patient who has had laparoscopic surgery to treat a ventral hernia using a mesh, be aware of this issue.If the patient is experiencing any signs or symptoms of recurrence of the hernia, or if they have any questions or concerns about this issue, refer them to their surgeon or the hospital where the surgery was undertaken.Information for hospitals and surgeons
Hospitals should inspect their stock and quarantine any unused Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Contact Johnson & Johnson Medical on 1800 252 191 (option 1) to arrange the return of any recalled devices.
Management of the patient remains at the discretion of the treating health professional and should be based on the individual circumstances of the patient.If you have any questions or concerns about this issue, contact Johnson & Johnson Medical on 02 9815 3661.Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
https://www.tga.gov.au/alert/ethicon-physiomesh-flexible-composite-mesh
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Gynaecologists voice concern over surgical mesh in women causing harm
Jun 10, 2016 | One News Now
By Lorelei Mason
There's concern doctors may have leapt in too quickly to use surgical mesh on women patients without waiting for proof it was safe.
That's the claim from some of the country's leading gynaecologists in the wake of a Health Select Committee report suggesting changes to reduce the harm caused to hundreds of patients through mesh use.
Transvaginal mesh has been in use worldwide since 2001, largely to surgically treat common prolapse and stress urinary incontinence issues in women.
But 27 clinical studies worldwide now show one in 12 patients go on to suffer complications, including having the mesh erode into other organs causing chronic pain.
An FDA alert in 2011 saw eight types of transvaginal mesh banned and there are now multiple international class action cases underway against mesh manufacturers.
ACC figures released to ONE News show over 500 patients have had claims accepted for mesh injury in the past decade with more than $10 million paid out for treatment and compensation.
Wellington gynaecological surgeon Dr Hanifa Koya has treated dozens of women in recent years, attempting to surgically remove embedded transvaginal mesh.
She says 50 of her patients have endured up to 10 procedures each to try and have it all removed.
"These people live in chronic pain thereafter and I never expected I would be dealing with people in so much agony," she says.
Greymouth grandmother Jeanne McEwan is one such patient.
She has been in constant chronic pain since having transvaginal mesh used to treat her prolapse problem in 2003.
"I havn't felt the same since it first went in and felt very sick and tired almost immediately," she says.
Ms McEwan, who is facing her seventh operation next month, says her Christchurch surgeon at the time reassured her the mesh was safe.
"I just feel like I was a total guinea pig," she says.
Auckland University Professor of Gynaecology Cynthia Farquhar says she now feels doctors worldwide raced to use transvaginal mesh back when it was new, before waiting for enough proof it was safe.
"There's no doubt in my mind we embraced it too quickly without waiting to see what the clinical trials were showing," she says.
The first international clinical trial results suggesting harm only started appearing from 2003 onwards.Both Professor Farquhar and Dr Koya support recommendations just released from the Health Select Committee to more carefully monitor surgical mesh use in New Zealand.
The recommendations came after two Auckland patients, Carmel Berry and Charlotte Korte, took a petition to parliament seeking an inquiry into all mesh, including mesh used for non-gynaecological procedures such as hernia repair.
The recommendations include having the government investigate setting up a national mesh registry to track mesh use and complication rates and also consider expanding Medsafe's role in assessing the quality and safety of all new medical devices.
Medsafe says its own investigations have concluded that surgical mesh is safe when used in accordance with the manufacturer's instructions by an appropriately-trained surgeon. It notes mesh remains approved by medical device regulators globally.
But Dr Koya believes transvaginal mesh for women patients should be banned.
"I do not use these products and it is my belief that all transvaginal meshes should be taken away," she says.
Professor Farquhar says it still has its uses in some patients.
"There is a place for it, probably not as a first line treatment but for women who are having second or third operations for prolapse," she says.
All agree, the risks must be fully communicated to all patients before surgery so women can make an informed decision.
https://www.tvnz.co.nz/one-news/new-zealand/gynaecologists-voice-concern-over-surgical-mesh-in-women-causing-harm
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Doubly Traumatized: Pelvic Mesh & the Sexual Abuse Survivor
Jun 9, 2016 | Pelvic Mesh Owners Guide
Two things happened this past week that make it imperative to write about the connection between two traumas: sexual abuse and pelvic mesh injury.
First, Melynda, a dually-traumatized woman wrote a tearful story of her trip to get atransvaginal ultrasound:
I arrive at my scheduled time, make my way to radiology and wait for someone to take me back to the room. My pain is an 8-9 at this point and I am starting to shake because, goddammintalltohell, I am so exhausted of having strangers fiddling with my lady parts, I can’t even sit down and relax. (Remember also I am a survivor of child sexual abuse/incest and rape when I was 17 and have had all the wretched trauma of mesh, too).
In walks this older gentleman in scrubs and says, “Are you here for an ultrasound?”
I was so confused. Why is there an old man telling me he is going to be doing my transvaginal ultrasound!!!!??????
I started crying right then and there. “No, no, no, no, NO. I can’t do this with you. I am so sorry, I need a woman tech.”
He tells me it’s him or I will be forced to reschedule. I lose it. I tell him I need some time to calm myself down and then I go lock myself in the bathroom and sit there for 15 minutes while I sob uncontrollably and struggle to breath.
Before this mesh disaster, I wasn’t like this. I could have pelvic exams with no problem. I have been to years of counseling to help me overcome the abuse/incest and rape and I count myself as a survivor of both of those things. But these mesh injuries and the resulting treatments I have to endure. That is what left me sobbing in the hospital bathroom, shaking so hard I couldn’t even hold my phone.Two days later, Buzzfeed published a document written to an arrogant rapist.The letter set off a maelstrom of outrage. The valiant victim described those hellacious moments when she slowly came to the realization she’d be brutally raped:
I … went to pull down my underwear, and felt nothing. I still remember the feeling of my hands touching my skin and grabbing nothing. I looked down and there was nothing. The thin piece of fabric, the only thing between my vagina and anything else, was missing and everything inside me was silenced. I still don’t have words for that feeling. In order to keep breathing, I thought maybe the policemen used scissors to cut them off for evidence.
Freedom is for women, too.
The physical and psychic numbness, immeasurable pain, wanting to shed her own body, and begging for time to process her trauma; while her attacker and the judge continue to intensify his horrific attack by turning the spotlight of blame onto her instead of him. Her words set off a campaign to remove the judge and, at the same time, further ignite the opprobrium of pelvic mesh-injured women who suffer so many of the same symptoms. A pelvic mesh-related injury feels like a rape in the aftermath. For all intents and purposes, it is rape, sometimes with genital mutilation.
For sexual assault victims, mesh pain takes them right back into a post traumatic state. Pelvic mesh victims are offered little redress while the device makers are permitted to increase sales, rush new versions to market, and continue to profit unfettered.You took away my worth, my privacy, my energy, my time, my safety, my intimacy, my confidence, my own voice…
How many pelvic mesh victims have uttered these same words? And these:
I am no stranger to suffering. You made me a victim. … For a while, I believed that that was all I was. I had to force myself to … relearn that this is not all that I am. … I am a human being who has been irreversibly hurt, my life was put on hold …
My independence, natural joy, gentleness, and steady lifestyle I had been enjoying became distorted beyond recognition. I became closed off, angry, self deprecating, tired, irritable, empty. The isolation at times was unbearable. You cannot give me back the life I had before that night either. While you worry about your shattered reputation, I …hold … spoons to my eyes to lessen the swelling so that I can see.
I … excuse myself to cry in stairwells. I can tell you all the best places … to cry where no one can hear you. The pain became so bad that I had to explain private details to my boss to let her know why I was leaving. I needed time because continuing day-to-day was not possible. I used my savings … I did not return to work full time … My life was put on hold for over a year, my structure had collapsed.
There are times I did not want to be touched. I have to relearn that I am not fragile, I am capable, I am wholesome, not just livid and weak.If you would like to join a small support group for people with both mesh injuries and a history of sexual abuse/assault, join here. ,–LINK UPDATED
Post Traumatic Stress Syndrome is common to both injuries and healing involves stages. No two women are ever alike and no healing patterns are identical. In hopes for your continued, safe, comforted, and thorough healing, here is a list of the stages:
I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at
http://pelvicmeshownersguide.com/2016/06/doubly-traumatized-pelvic-mesh-the-sexual-abuse-survivor/
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