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Ethicon Media Monitoring 01/16/2017
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Nobody knows the true scale of the pelvic mesh scandal - but new figures show it could be as high as almost 40 per cent
Jan 15, 2017 | Wisbech Standard
By Kath Sansom
The true scale of the risk of surgical mesh to treat women’s incontinence and prolapse remains a mystery amid findings from America that say up to almost 40 per cent of women suffer injuries from the hooked instruments used to implant it. -
Caldera Transvaginal Mesh Update: Individuals Treated Unfairly for No Reason Grounded in Rationality or Fairness
Jan 14, 2017 | Mesh Medical Device Newsdesk
This writer, implanted with Caldera Medical’s transvaginal mesh, is one of 4,000 facing litigation against Caldera which has yet to offer a rational settlement, she says in this Op-Ed. She wishes to remain anonymous because she is involved in litigation.
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Jan 15, 2017 | Wisbech Standard
By Kath Sansom
The true scale of the risk of surgical mesh to treat women’s incontinence and prolapse remains a mystery amid findings from America that say up to almost 40 per cent of women suffer injuries from the hooked instruments used to implant it.
In America, health watchdog body the FDA, has announced that the trocars - hooks which a surgeon uses to push mesh implants through the pelvic cavity - cause a raft of injuries leading to them being reclassified as higher risk devices.
The figures may shock patients waiting to have surgery in the UK who are told risks are as low as one to three per cent in figures published by UK watchdog body the MHRA.
Hospital episode statistics suggest TVT mesh tape complications in England are one in 11 women (8.56 per cent risk) - but that figure is woefully low as it is grossly under reported by patients, surgeons and manufacturers.
A Canadian study says pelvic mesh risk is 15 per cent.
Sling the Mesh campaigner Kath Sansom said: “The grim reality is that nobody has a clue of the true scale of risk because no country has a National Register to track women throughout the lifetime of their mesh implant.
“What we see as campaigners globally is that women’s physical and mental health is being seriously compromised forever in what is sold as a simple 20 minute fix for an embarrassing problem.
“None of us were warned of the devastating risks which include nerve damage, chronic leg, groin or pelvic pain, losing a sex life and urinary tract infections.”
Scottish Mesh Survivors campaigner Elaine Holmes said: “In the last nine months, US health watchdog FDA has issued two final orders to reclassify pelvic mesh for organ prolapse to high risk Class III and heightened the risk category for surgical instrumentation.
“In addition, they issued a safety alert for urogynecologic surgical mesh implants by Boston Scientific, notifying American women of the potential for counterfeit raw material.
“The UK health watchdog MHRA chose not to issue these notifications and safety alert to inform and protect UK women - why?”
The FDA says instruments used to place pelvic mesh have been upgraded from Class I low risk to Class II higher risk which require greater controls.
In a ruling published this month FDA figures reveal
• Up to 39.1 per cent of women suffer nerve injuries from instruments used during prolapse repairs.
• Up to 29.4 per cent of women suffer vascular injury and bleeding during insertion of a TVT mesh sling.
• Up to 23.8 per cent of women suffer organ perforation and injury from TVT insertion.
• Up to 5.3 per cent of women suffer nerve damage and pain from TVT insertion.
Prof Tom Joyce, professor of orthopaedic engineering at Newcastle University said there is an on-going crisis with medical implants because they are approved too easily and their performance not properly monitored.
He said: “A key issue is the ‘precautionary principle’. If there is a chance of harm then its use is stopped while the potential problem is investigated.
“We see this approach in cars and aircraft with thousands of vehicles brought back to be checked and planes grounded while investigations are undertaken.
“The same precautionary approach does not appear to happen when there are concerns with medical implants.
“This should change. When major concerns exist, implantation of specific medical devices should stop and evidence be gathered and assessed so that an informed decision on benefits and risks can be made.
“Patient safety has to be prioritised.”
London-based surgeon Sohier Elneil said she is inundated by women asking for help and believes there are grounds for the procedure to be banned.
She said: “I used to see one or two a month who wanted the mesh taken out and now it’s more like five a week.
“There was a huge uptake of this therapy well before we had all the evidence and the research into it so until we have that, which is now being done in retrospect, I think it’s very difficult to keep on using them.
“For some patients, this surgery is of benefit but for some women it is a personal tragedy.”
Canadian surgeon Robert Bendavid said: “The industry has been crafty in imparting the idea that it is a simple operation and sure enough it is, but the complications are monumental, especially when alternative pure tissue repairs are available.”
A spokesman for the MHRA said: “Between January 2016 and December 2016, MHRA received 171 adverse incident reports relating to gynaecological mesh to treat incontinence.
“These figures include a range of recognised complications related to this type of surgical procedure and do not necessarily indicate a fault with any particular device and because there is no time limit on reporting, trends need to be interpreted using other data.
“Reported incidents may not necessarily represent individual patients as an individual could experience adverse incidents at different times which result in separate reports.
“Additionally, an adverse incident report could contain a number of complications being experienced by a single patient.
“Patient safety is our highest priority and we continue to monitor this issue.
“MHRA encourages anyone who suspects they have had a complication after having a mesh device implanted, to discuss with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.”
http://www.wisbechstandard.co.uk/news/nobody_knows_the_true_scale_of_the_pelvic_mesh_scandal_but_new_figures_show_it_could_be_as_high_as_almost_40_per_cent_1_4849954
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Jan 14, 2017 | Mesh Medical Device Newsdesk
This writer, implanted with Caldera Medical’s transvaginal mesh, is one of 4,000 facing litigation against Caldera which has yet to offer a rational settlement, she says in this Op-Ed. She wishes to remain anonymous because she is involved in litigation.
This opinion does not necessarily reflect the opinions of Mesh News Desk.
Stop it! MDLs make up nearly half of the federal civil docket. It is a serious failure of our individual rights.
Every woman harmed by Caldera Medical, Inc. transvaginal mesh implants have separate causations; some had no informed consent, some never knew of the implant placement, and were given different information from surgeons and hospitals and their staffs. Causation lies in the manufacturers, surgeon, staff and physicians, and facility whom purchased and marketed these devices, implanted these devices and brought to market these devices with multiple manufacturers. Each woman has a unique version of how she was harmed.
Your tier systems you agreed upon, they are not fair or rational.The problem is that the plaintiff lawyers making many of the decisions in an MDL (usually adorned with the regal title of “the plaintiff steering committee”) do not represent all the plaintiffs.
Stop it. It is an ugly problem and if MDL attorneys have not been told by a client who sues you and wins; it is legal malpractice. Mass Tort attorneys have hurt us. We may never recover. You have reared your ugly heads to steal from us as Americans the most sacred of trusts:
he right to trial by jury.
Our right to protect our bodies from the medical battery.
The right to have our marriages protected; these transvaginal mesh devices destroy our bodies, our marriages, our professions on a scale never before seen in America.
Individuals get treated as an aggregate, and some make out better than others for no reason grounded in rationality or fairness and others left with nothing. MDL plaintiff lawyers steer more dollars toward their cases than others; take the gentlemen’s agreement in the Caldera Medical Inc. class action and the deliberate unwillingness to litigate our cause and obtain our damages from American Medical Systems whose novel surgical tools are part of the Caldera Medical, Inc kits.
The MDL statute was developed as a judge-centric model – its framers intended that judges would wrestle control of cases from the litigants and guide the litigation to a conclusion that would relieve the federal courts of potentially crushing caseloads.
Well, MDLs fail. They fail us all. We do not care about case loads. We want fairness! We want our trials in our communities. We want our jury of 12 to hear about all the parties involved who destroyed us. We want fairness!
What’s the solution? As an injured woman, I point with favor to the judge in the World Trade Center Disaster Site Litigation who expressed the view that a proposed settlement was not enough. That judge, according to the authors, based his authority to reject the settlement on a quasi-class action theory created by Judge Weinstein the Zyprexa MDL.
The WTC judge acted as an “information intermediary.” Once he put it out there that the settlement was, by his lights, unfair, it was not possible to cram the settlement down the throats of plaintiffs.
I hope MDL attorneys do read this site and take pause as to the harm we are suffering because we as individual Americans are not being treated fairly. In the 21st century with life science policies and biomedicine, the strong interest is in settling cases, not fairness. WE WANT FAIRNESS!The system must now be subordinate to the rights of the individual American who suffers life altering harm through the implantation of surgical mesh.
PLEASE do not approve settlements that are unfair to plaintiffs. MDL litigation thrives on the concept “Settlement is good.” When you are harmed as we are in such a personal and intimate way, where most of us will never make love to our spouses again; we believe a jury verdict in our State courts is justice.
I am a Grandmother; I do not want to see American granddaughters and great-granddaughters be implanted.
Until surgeons, facilities and executives are found in State courts to be responsible for our harm along with the manufacturers we will not have been treated fairly.
Not All Settlements are Good. Some are neatly wrapped gentlemen’s agreements that leave our lives, our marriages, our health and our hope trampled on the floor of justice.
http://www.meshmedicaldevicenewsdesk.com/caldera-transvaginal-mesh-update-individuals-treated-unfairly-no-reason-grounded-rationality-fairness/
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