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Ethicon Media Monitoring 11/18/16
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Mesh slings used in hospitals across the region are a bigger health scandal than Thalidomide, says leading politician
Nov 22, 2016 | Ely Standard
By Kath Sansom
Mesh slings to treat incontinence and prolapse in women is a scandal as big as the morning sickness drug, Thalidomide, that gave babies deformed limbs in the 50s and 60s, according to a leading Australian politician. -
Win and Loss for Bard as Avaulta Pelvic Mesh Case Readies for Court
Nov 22, 2016 | Mesh Medical Device Newsdesk
The plaintiff can pursue a punitive damage but not a negligence claim in this Bard Avaulta defective pelvic mesh case that is being readied for trial or to be remanded back to state court. -
Defying Gravity: A Better Pelvic Organ Prolapse Procedure
Nov 22, 2016 | North American Press Syndicate
Women suffering from pelvic organ prolapse (POP) often feel as though organs are falling out of their body. In these advanced stages of prolapse, surgery is one option that is available, but is controversial.
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Nov 22, 2016 | Ely Standard
By Kath Sansom
Mesh slings to treat incontinence and prolapse in women is a scandal as big as the morning sickness drug, Thalidomide, that gave babies deformed limbs in the 50s and 60s, according to a leading Australian politician.
His outcry has been welcomed by mesh campaigners around the world, including Cambridgeshire Sling The Mesh campaigner, journalist Kath Sansom.
“Earlier this year Scottish Parliament said mesh implants are as bad a cover-up as asbestos and now this. The dangers are finally being recognsied,” said Kath, who launched her campaign 18 months ago and how has nearly 1,000 members in her Facebook support group.
Senate Derryn Hinch said the permanent mesh implant had ruined the lives of thousands of women around the world and was one of the worst medical disgraces of modern times.
Speaking in Parliament today (Tuesday 22) he said mesh had: “crippled thousands of mothers both here and overseas,” and added it was: “one of the greatest medical scandals and abuses of mothers in Australian history.”
In a hard hitting speech that threw punches at the medical industry and watchdog bodies who are supposed to protect patients he said women had been: “Treated like mushrooms – kept in the dark and fed bullsh#t by doctors, hospital administrators, drug companies and even the TGA.
“At times they have almost believed that their pain and their debilitating condition was psychosomatic or just a way to get more pain killers that’s what the doctors suggested,” he said.
“There are only a few renowned surgeons in the world who can safely remove them.
“These devices are in a woman’s pelvis until she dies.”
His speech came after Australian mesh injured mum Caz Chisolm travelled from her home in Perth to Melbourne to meet Senate Hinch to beg him to speak out on behalf of women around the world and to call for an enquiry.
“This ‘harmless’ plastic netting can become brittle and start to break away in shards and splinters they start to float around the body causing inflammation and excruciating pain,” said Senate Hinch.
“There have been cases where a splinter has pierced a woman’s vaginal wall and injured her partner during intercourse so no wonder some of these mesh products have been totally banned in Scotland.
“No wonder these slings have been called a torture device.”
The mesh should be clinically inert, which means before being implanted it must be guaranteed to not change on contact with tissue fluid in the body, it wont produce allergic reactions, wont incite inflammation, wont trigger the immune system, wont harbour and breed bacteria and will stay anchored in the body, he said.
“Tragically, painfully, dangerously, transvaginal mesh does not pass any of those tests. To make the nightmare worse these mesh hammocks are anchored deep into thigh and buttocks and pelvic region muscles where nerves grow through the mesh making it about impossible to remove things when the things go wrong,” he said.
The pain is so excruciating for some that suicide has become a normal thought, he added.
Erosion, nerve and organ damage can happen immediately or can take up to 15 years, he said while nobody is warned of risks and nobody is tested for allergic reactions to polypropylene prior to surgery.
Other side effects include infection bleeding, painful sexual intercourse, vaginal scarring, prolapse returning, sepsis, immune system rejection, urinary problems and chronic pain.
“It’s a national disgrace,” he said.
In the UK the watchdog body, the MHRA says the benefits of mesh slings outweigh the risks and claim the complication rate is around one to three per cent.
Its figures rely on women reporting it via their Yellow Card scheme which many have never heard of.
• Log on to Facebook to Watch the Australian Parliamentary speech
http://www.elystandard.co.uk/news/mesh_slings_used_in_hospitals_across_the_region_are_a_bigger_health_scandal_than_thalidomide_says_leading_politician_1_4788167
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Win and Loss for Bard as Avaulta Pelvic Mesh Case Readies for Court
Nov 22, 2016 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, November 22, 2016 ~ The plaintiff can pursue a punitive damage but not a negligence claim in this Bard Avaulta defective pelvic mesh case that is being readied for trial or to be remanded back to state court.
While mesh trials have not been in the courtroom or the headlines for some months now, there is quiet wrangling going on behind the scenes in a Bard Avaulta case.
Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia, where nearly 100,000 pelvic mesh cases are consolidated in multidistrict litigation, had asked mesh manufacturer, C.R. Bard to come up with 50 cases it could prepare for trial. At the same time, he also asked the plaintiffs side to come up with 50 Bard defective product cases.
These are Wave One and Wave Two cases, being prepared for trial or to be remanded back to state court.
In an order issued November 15, Judge Goodwin granted one summary judgment motion in favor of Bard and another motion in favor of the plaintiffs in a Wave One case.
The case is that of Donna Kaiser v. C.R. Bard Inc. (2:12-cv-03655).
Kaiser was implanted with the Avaulta Solo Anterior Synthetic Support System in Pembroke Pines, Florida by Dr. Harvey Samowitz at Memorial Hospital West.
In her seven count case, filed July 25, 2012, she alleges design defect, manufacturing defect, a failure to warn, negligence breach of express and implied warranties, loss of consortium and punitive damages.
PUNITIVE DAMAGES WILL STAY
n Doc #209, Judge Goodwin denied Bard’s Motion for Partial Summary Judgment on punitive damages. Summary Judgment resolves issues before trial and makes them go away. (Here is Doc #209)
In issuing the order, Judge Goodwin said the question of punitive damages is often interlocked with factual determinations which at this stage are “frequently muddled enough on the point that genuine issues of material fact remain. That is the case here.”
In other words, it’s best for a jury to decide these things.
The plaintiffs will be able to seek punitive damages that punish a company, if and when the case goes to trial.
On the same day, Judge Goodwin granted Bard’s Motion for Summary Judgment (Doc #210 Here)on manufacturing defect, breach of implied and express warranty, negligent inspection, packaging, marketing and selling. Those arguments will not be allowed to be presented to a jury. Judge Goodwin said the plaintiffs’ attorney failed to make a case that Bard negligently inspected and marketed Avaulta.
The plaintiff is represented by Wagstaff & Cartmell. Defendant lawyers are Reed Smith and Nelson Mullins Riley & Scarborough.
The other counts can be pursued such as failure to warn and strict liability meaning when the product was put in the stream of commerce it was unreasonably dangerous and the risks exceeded the benefits, and that the defendant acted with a conscious and deliberate disregard of that foreseeable harm.
C.R. BARD PELVIC MESH
Judge Goodwin reminds both sides there are currently 58,000 open cases pending in this multidistrict litigation and 8,000 defective product cases name C.R. Bard Inc. are pending.
In order to try and get through the massive numbers of cases, he decided to conduct pretrial discovery and motions practice on a case-by-case basis so that once a case is ready for trial, it can promptly move onto his court or be remanded back to another.
Last year Bard agreed to settle 3,000 mesh cases for $200 million and 6,254 cases are now listed as closed in this federal consolidated court case. In 2014 Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
Bard, based in Georgia, manufactures various medical devices including:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Faslata® Allograft
Pelvicol® Tissue
PelviSoft® Biomes
Pelvitex™ Polypropylene Mesh
The Bard litigation was consolidated in October 2010 in multidistrict litigation in the Southern District of West Virginia before Judge Goodwin.
The Avaulta was taken off the market in June 2012 after the FDA required mesh manufacturers to conduct a three-year post-approval monitoring of women already implanted with the mesh product to assess their condition. The company said it was making a business decision not to invest in the clinical trials for the Avaulta. ###
LEARN MORE:
Seven Causes of Action Kaiser Case:
1. Strict product liability, failure to warn
2. Strict Liability – without warnings and instruction and being defective in design they were placed in the stream of commerce while the Defendant acted with conscious and deliberate disregard of the foreseeable harm caused by pelvic mesh products
3. Negligence – Defendant (Def) failed in its duty to properly manufacture, compound, test, inspect, package, label, distribute, market, examine, maintain supply, provide proper warnings and prepare for use and sell the product. Injuries resulted to plaintiff.
4. Breach of Implied Warranty- Def. warranted its pelvic mesh products were fit and safe for ordinary use or correcting POP (pelvic organ prolapse) and SUI (stress urinary incontinence). Therefore Def. breached the implied warranty of merchantability and fitness for a particular purpose. Instead it is defective, eroded, caused dense scarring and otherwise failed to function causing permanent injuries.
5. Breach of Express Warranty –Def. relied on sales agents and brochures to assure the general public the products were safe, effective, fit and proper for their intended use, which was untrue, says the plaintiff.
6. Negligent Misrepresentation – Def. made representation that the mesh for POP and SUI was safe with no reasonable ground for believing that to be true and its own data showed the products to be defective and dangerous. Those representations were made to the physicians who relied on the assurances the mesh was safe to use.
7. Loss of Consortium- filed on behalf of the spouse who has lost an intimate relationship with his wife due to the Def’s negligent conduct.
http://www.meshmedicaldevicenewsdesk.com/win-loss-bard-avaulta-pelvic-mesh-case-readies-court/
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Defying Gravity: A Better Pelvic Organ Prolapse Procedure
Nov 22, 2016 | North American Press Syndicate
(NAPSI)—Women suffering from pelvic organ prolapse (POP) often feel as though organs are falling out of their body. In these advanced stages of prolapse, surgery is one option that is available, but is controversial. Many women who suffer from POP are apprehensive about having surgery due to the Food and Drug Administration (FDA) warning about the high-risk mesh that is often used by surgeons for prolapse repair, as well as the lack of complete data on long-term success of the surgery.
A modern version of a pelvic organ prolapse repair surgery that is used to lift the top of the vagina and restore stability to the pelvic floor can now be performed as a laparoscopic prolapse repair without the use of mesh, though few specialists are trained in this delicate procedure.
“Weaknesses in the pelvic floor can be corrected and the top of the vagina or cervix successfully suspended to the supporting ligaments through a minimally invasive GYN procedure that has a better long-term success rate,” said Rupen Baxi, M.D. “Performing a minimally invasive sacrospinous ligament suspension is an advanced technique that has a high rate of success for women who have advanced stages of the disease.”
“This procedure takes years of training and must be performed by a specialist who understands the appropriate techniques for repairing bladder prolapse, rectum prolapse or uterine prolapse without the use of mesh,” continued Dr. Baxi. “The procedures performed by the specialists at The Center for Innovative GYN Care require only two small incisions and most of the procedure is performed vaginally, so there are no large scars.”
POP is a condition that can worsen over time and is diagnosed by stage. Often, the early stages don’t affect a woman’s day-to-day life. When the condition worsens, however, the symptoms can range from difficulty going to the bathroom or not being able to control when to go, discomfort or embarrassment having sex, or a feeling that something is pressing against or falling out of the vagina. Treatment escalates as the stages progress.
“Women who require surgery for prolapse can now seek out a CIGC minimally invasive GYN specialist who can perform a laparoscopic suspension procedure that has no need for the controversial mesh, and that has a fast recovery with better long-term results,” said Dr. Baxi.
http://www.napsnet.com/articles/72375.html
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