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Ethicon Media Monitoring 9/15/2017
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Vaginal mesh expert: Lack of robust response in Wales
Sep 14, 2017 | BBC
By Kate Morgan
A leading clinician has criticised what he calls a lack of "robust" action in Wales over the use of vaginal mesh. -
Arkansas Woman Claims Other Mesh is Safer and More Effective than Physiomesh
Sep 14, 2017 | The Legal Examiner
By Roopal Luhana
An Ethicon Physiomesh lawsuit is pending in New Jersey state court. An Arkansas woman filed the case on August 3, 2017, in Middlesex County, claiming that after she was implanted with the mesh, she suffered from serious injuries. -
Surgical Mesh Manufacturer to Appeal Revival of Mesh Lawsuit
Sep 15, 2017 | Lawyers And Settlements
By Gordon Gibb
Philadelphia, PAA surgical mesh lawsuit plaintiff whose case fell to a defense verdict at trial, may nonetheless come away with something after the trial judge granted the plaintiff’s petition for damages.
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Vaginal mesh expert: Lack of robust response in Wales
Sep 14, 2017 | BBC
By Kate Morgan
A leading clinician has criticised what he calls a lack of "robust" action in Wales over the use of vaginal mesh.
Dr Wael Agur, who has advised the UK and Scottish governments, supports calls to ban mesh for vaginal prolapse.
Following reviews, Scotland and England now do not routinely recommend it for such surgery.
Wales' chief medical officer said it had "systems and structures" to get the same outcome without the same action.
Dr Agur said: "I've seen little from the Welsh Government. There does not seem to be continuing participation in the mesh groups.
"And there does not seem to be a robust view on the benefits and risk of these procedures - and that surprises me."
He said it was particularly surprising, given it was leading urologists and urogynaecologists in Wales who had conducted what he considered one of the best studies in the area.
Mesh implants, which include different types of plastic tape and slings, are used to ease incontinence and to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
Some have caused painful and debilitating complications for patients, with hundreds of UK women launching a legal action against the NHS.
The polypropylene meshes are still prescribed on the NHS across the UK, however recent reviews in England and Scotland said they should not be routinely used for pelvic organ prolapse.'It's just torture'
Grandmother Jemima Williams, 57, of Barry, Vale of Glamorgan, said she often struggles to get out of bed due to complications arising from a vaginal implant for a prolapse.
She wants the products banned.
"It's just torture," she said. "It's an instrument of medieval torture. It's horrible. And it takes you to the darkest of places.
"It's like a cheese grater or a cheese wire cutting into your most intimate parts. It's a pain that you can never get away from."
Ms Williams said she once lived an active life but she now needs a stick to walk and cannot drive.
The Welsh Government said it was building on work already done this side of the border by accepting the conclusions of the latest NHS England report.
It was part of the UK group that informed that review and is now setting up a task group to make sure the recommendations are properly implemented here.
Wales' chief medical officer, Dr Frank Atherton: "We're looking now to make sure in Wales that clinicians and the service we provide is consistent with the recommendations contained in these reports."
Dr Atherton said that while the Welsh Government had not issued specific guidance on the routine use of mesh tape in prolapse surgery in the same way as England and Scotland, it had "taken the same line" but via "a different route".
"We expect all of our services to comply with the standards and the guidelines, set out...by the various speciality societies and they are very clear that, for example, in pelvic organ prolapse, as a primary repair that mesh is not appropriate in those circumstances."
He added: "I believe we have the right systems and structures in place here in Wales to make sure that we get the same outcome as Scotland and England and that where mesh is used, it is used appropriately."
http://www.bbc.com/news/uk-wales-41252705
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Arkansas Woman Claims Other Mesh is Safer and More Effective than Physiomesh
Sep 14, 2017 | The Legal Examiner
By Roopal Luhana
Roopal Luhana is an attorney with Chaffin Luhana LLP
An Ethicon Physiomesh lawsuit is pending in New Jersey state court. An Arkansas woman filed the case on August 3, 2017, in Middlesex County, claiming that after she was implanted with the mesh, she suffered from serious injuries. The manufacturer, a subsidiary of Johnson & Johnson, is headquartered in Somerville, New Jersey and in Cincinnati, Ohio.
The plaintiff seeks both compensatory and punitive damages.Plaintiff Had to Have Ethicon Physiomesh Removed
According to the complaint, the plaintiff underwent a laparoscopic ventral umbilical hernia repair procedure on October 27, 2014. Her surgeon used Ethicon’s Physiomesh to reinforce the affected area and provide a lasting solution.
On or about May 28, 2015, the plaintiff had to undergo a second surgery to remove the Physiomesh. It had disconnected and tore, leaving fragments in the surrounding tissue, and resulted in a failure of the original repair. On that day, the surgeon implanted another mesh to again fix the hernia.
The plaintiff claims she has experienced and continues to experience pain in the lower part of her stomach, sores on her stomach, blisters, stinging, and the removal of her naval. All of these complications occurred after the implantation of the mesh. She blames the defendants for her injuries, and for the psychological trauma she’s suffered.Physiomesh Products Recalled for High Rates of Recurrence
An umbilical hernia is one of the most common types of hernias, typically occurring when part of the bowel or fatty tissue pokes through an area near the belly button. The area of protrusion is usually a weak area that exists in the surrounding abdominal wall. These types of hernias are more common in women than in men, and show up as a bulge or swelling near the belly button. The bulge may become more visible when the person laughs or coughs.
Sometimes the hernia causes no symptoms, but other times it can cause pain and swelling. Surgery may be recommended to alleviate these symptoms or prevent additional complications. During the repair procedure, the doctor pushes the bulge back into place and then stitches muscle layers over the area to strengthen it. He or she has the option to use a piece of mesh, like Physiomesh, to reinforce the repair and help keep tissues and muscles in place.
Ethicon’s Physiomesh, however, was recalled back in May 2016. Recurrence and reoperation rates after laparoscopic repair were higher than the average rates for comparable meshes. The company released an urgent field safety notice to hospitals, surgeons, and medical centers warning them to stop using the products and to send any unused units back.
The plaintiff states in her complaint that other brands of mesh are safer and more effective than Physiomesh and notes that the FDA’s medical device reports database has documented instances of Physiomesh pulling away from the abdominal wall, embedding into the abdominal wall, and causing recurrent hernias and intestinal fistulas.
She brings counts of defective design and manufacture, failure to warn, negligence, breach of warranties, fraudulent and negligent misrepresentation, and unjust enrichment.
http://westvirginia.legalexaminer.com/medical-devices-implants/arkansas-woman-claims-other-mesh-is-safer-and-more-effective-than-physiomesh/
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Surgical Mesh Manufacturer to Appeal Revival of Mesh Lawsuit
Sep 15, 2017 | Lawyers And Settlements
By Gordon Gibb
Philadelphia, PAA surgical mesh lawsuit plaintiff whose case fell to a defense verdict at trial, may nonetheless come away with something after the trial judge granted the plaintiff’s petition for damages. The manufacturer of the pelvic mesh involved, Ethicon Inc. (Ethicon), has appealed the judge’s ruling that the matter can progress to a damage hearing. In so doing, Kimberly Adkins’ case has been revived, at least for now.
The primary defendant in the surgical mesh side effects lawsuit is Ethicon, a subsidiary of Johnson & Johnson. Ethicon is facing in excess of 100 lawsuits in the pelvic mesh mass tort currently housed in Philadelphia. In what was the fifth case in the mass tort to go to trial, the jury on June 9 delivered for Ethicon what was the defendant’s first defense win in the 5 cases.
Ten days later, according to The Legal Intelligencer (08/17/17), Adkins responded to the verdict with a post-trial motion asserting that the jury’s findings were inconsistent with regard to the issue of whether, or not a design defect alleged in the surgical mesh complications lawsuit – a defect acknowledged by the jury – caused the injuries to Adkins.
To that end, the jury had determined that the Ethicon TVT-Secur mesh implanted in Adkins had, indeed been designed with certain defects. However, failing to identify that the product may have caused Adkins’ injuries went against the weight of the evidence, according to the plaintiff.
Adkins’ post-trial petition found favor with the judge in the Philadelphia Court of Common Pleas, who revived the surgical mesh lawsuit in July and directed that the case move to a damages hearing.
Ethicon promptly filed an appeal of the judge’s ruling with the Pennsylvania Superior Court. A spokesperson for Ethicon, identified as Kristen Wallace, said in a statement published in The Legal Intelligencer that the trial jury in the Philadelphia Court of Common Pleas had, indeed determined that the Ethicon surgical mesh had not been the cause of the plaintiff’s injuries.
“We have filed an appeal to the Superior Court solely regarding the granting of a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” Wallace said.Adkins’ legal team announced it would be opposing the appeal, noting that any further delay fostered by legal proceedings would only delay the determination of damages for the harm, and suffering experienced by the plaintiff.
Court heard that Adkins suffered when the Ethicon TVT Secur implant eroded into the plaintiff’s vaginal canal, causing Adkins much pain. A portion of the surgical mesh was removed by way of a surgical procedure in September, 2012 – however the pain continued. Her attorneys note that even in the aftermath of the revision surgery, the plaintiff has been largely robbed of her capacity to enjoy normal sexual relations with her partner of 20 years.
Adkins filed her surgical mesh complications lawsuit in July, 2013. The case is Kimberly Adkins v. Ethicon Inc. et al., Case No. 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/surgical-mesh-lawsuit-tvm-22573.html
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