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ethicon 13/6
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Ethicon mesh plaintiffs claim company expert admitted mesh degrades
Jun 10, 2016 | Mass Device
By Fink Densford
Plaintiffs in the multi-district litigation brought over the pelvic mesh made by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon claimed this week that a company expert admitted that Ethicon knew back in 1992 that the plastic used in its mesh degrades after implantation. -
Caldera Final Pelvic Mesh Settlement Deadline Facing Opposition
Jun 11, 2016 | Mesh Medical Device News Desk
Editor’s Note: We’ve called her “Samantha” and at the present time she, along with a few other women, are attempting to opt out of a mandated pelvic mesh settlement offered by mesh manufacturer, Caldera Medical. -
European Union Cracks Down on Toxins in Plastic Used for Medical Devices
Jun 12, 2016 | Mesh Medical Device News Desk
By the time young Dustin Hoffman was being schooled on his future in the 1967 film, “The Graduate,” the medical industry had discovered plastics. -
Labour calls for more scrutiny of surgical mesh
Jun 11, 2016 | Newshub
By Mike Wesley-Smith
Labour has asked the health and disability commissioner to launch an investigation into the use of surgical mesh, after two women launched a commission of inquiry. -
NZ First calls for halt to the use of surgical mesh
Jun 12, 2016 | Voxy.co.nz
New Zealand First is calling for a halt to the use of surgical mesh until it is proven to be safe.
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Ethicon mesh plaintiffs claim company expert admitted mesh degrades
Jun 10, 2016 | Mass Device
By Fink Densford
Plaintiffs in the multi-district litigation brought over the pelvic mesh made by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon claimed this week that a company expert admitted that Ethicon knew back in 1992 that the plastic used in its mesh degrades after implantation.
The case concerns damages reportedly caused by Ethicon’s pelvic mesh products.
Plaintiffs in the case argue that the defendant’s witness, Dr. Thomas Barbolt, admitted that Ethicon’s Prolene mesh devices undergo in vivo surface degradation, and that bound the defendants to that opinion.
The defendants in the case later hired Steven MacLean as an expert witness, according to court documents, in an “effort to undo this damaging testimony” by presenting opinions that contradict Dr. Barbolt’s earlier testimony.
Plaintiffs in the case referenced multiple issues with MacLean’s testimony, calling data he presented from a 7-year dog study and other molecular weight opinions “unreliable,” and said he is “unqualified to offer pathology opinions.”
MacLean was accused of “cherry-picking” data from various different studies and subjects to support his opinions that the Prolene device does not degrade, according to court documents.
http://www.massdevice.com/ethicon-mesh-plaintiffs-claim-company-expert-admitted-mesh-degrades/
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Caldera Final Pelvic Mesh Settlement Deadline Facing Opposition
Jun 11, 2016 | Mesh Medical Device News Desk
Mesh News Desk, June 10, 2016 ~ Editor’s Note: We’ve called her “Samantha” and at the present time she, along with a few other women, are attempting to opt out of a mandated pelvic mesh settlement offered by mesh manufacturer, Caldera Medical.
You may recall in February, Agoura Hills, California based – Caldera Medical, said it was insolvent, had about $25 million in insurance coverage to settle defective product claims by 2,184 Caldera mesh-injured women. Take it or leave it, no opt-out. See the story here.
Half of that money has already gone to cover litigation costs between Caldera and its insurance carrier, Federal, a subsidiary of the giant Chubb Limited Insurance Company. See the complaint here.
It’s not surprising the money went so fast. For example, the mediator in the case, Robert Kaplan, charges $1,000 an hour, $10,000 a day.
“If litigation continues, the Policies will be swiftly exhausted, Caldera will be forced into bankruptcy, and most or all of the claimants will receive nothing,” Caldera claims in the May 16, 2016, Joint Motion for Final Settlement and Approval of Class Certification.
The agreement, if signed by women injured with Caldera pelvic mesh, will provide the injured claimants with approximately $2,000 per individual. They will be required to sign a non-disclosure agreement and forever be forbidden from seeking any future damage claims against Caldera Medical. Caldera will admit no fault.
When Caldera Medical announced it was insolvent earlier this year and had no cash on hand or liquid funds to contribute to a settlement, it laid out its plans for the future. The company will form a partnership with IVUMed to implant one million women in third world countries with its pelvic mesh.
The URL for the announcement indicates it has federal subsidy (Affordable Care Act) grant support. See the link here. See the story here.
ow a little over $11.75 million in insurance dollars is left for the injured women, which has now grown to 4,000 claimants in the last couple of months. Each woman will receive less than previously predicted.
FINAL APPROVAL HEARING
On Monday, June 13, a District Court in Los Angeles will hold the “Final Approval Hearing,” to decide whether to approve the Settlement and Class Counsel’s requests for fees and expenses. Caldera claimants may attend, but do not have to. They may be able to speak if they do not have an attorney present but must request permission to speak at the hearing. (See the Los Angeles Court location at the bottom of this story).
So far, there are 47 objections filed. Samantha is mentioned along with several other women. She is filing her objections Pro Se, or without an attorney. Thirty-seven objections were filed by the law firm, Kline & Specter, of Philadelphia, and by the Mazie Slater law firm of New Jersey.
Kline & Specter objects that claimants should be allowed to opt out “and have their day in Court.” (Never mind that “no opt-out” it is a violation of ones Seventh Amendment right to seek redress in a court of law.) Besides, some women, Samantha to name just one, were implanted outside of Caldera’s insurance coverage between 2008 to 2011.
Technically these women should be able to opt out of the final agreement, the law firm argues. Chubb says the coverage was retroactive.
Samantha filed an objection too. She was implanted with a Caldera T-sling 22 months before it was FDA approved for sale under the FDA’s 510(k) process, and years before there was any insurance coverage. In other words, it was not even on the radar of the FDA. Because of that, she calls the procedure she underwent “experimental.”
Chubb, in reading Samantha’s objection, refers to it in the Joint Motion as a “misunderstanding.”
Samantha suggests that our daughters may be facing hysterectomy in the future, this is the darkest time in American urogynecologic history. This litigation is about more than a defective mesh fabric, it’s also about the implanting method and about female genital mutilation. The health effects are similar – recurrent infections, difficulty urinating and passing menstrual flow, chronic pain, the development of cysts, an inability to get pregnant, complications during childbirth, and fatal bleeding..
Samantha has complained to Chubb that all mesh makers who colluded to share patents for the implant method are implicated and should share responsibility.
TRANSOBTURATOR SURGICAL MESH IMPLANT METHOD – SHARING PATENTS
This is where it gets a bit complicated but it is a layer that has not been addressed so far. Until 1999, medical procedures could not be patented. But the method of placing most transvaginal tape-obturator is patented and shared by TVT-O manufacturers. It is considered Intellectual Property. The Transobturator Surgical Mesh Implant Intellectual Property Medical Method, is how the TVT-O was brought to market, regardless of the company.
Samantha calls it a failed procedure which implicates all of the companies which Chubb insures because they have an interlocking patent history and all share financial gain from the method.
Here’s how it works. First, Mentor infringed on Ethicon/Johnson & Johnson on their patent – US6638210. September 26, 2001.
Infringe means a manufacturer uses an invention that is owned by patent by another entity without obtaining permission. The infringing party is liable to the owner of the patent for all profits made from the use of that invention. They can enter into a licensing agreement to share profits. In December, 2008, J&J acquired Mentor for about $1.07 billion.
US6638211 Mar 5, 2002 Oct 28, 2003 became the patent for Mentor Corporation’s method for treating urinary incontinence in women and implantable device intended to correct urinary incontinence.
American Medical Systems (AMS) infringed upon Mentor through their US6911003 March 3, 2003. On June 28, 2005, AMS Research Corporation Transobturator surgical articles and methods and Caldera Medical, Inc. infringed upon American Medical Systems, Inc. Implants and procedures for treatment of pelvic floor disorders, US 8480558 B2, created by Francois Blaudeau, Vice President of Caldera Medical, Sandra Muhlfeld, CEO of Caldera Medical, Inc. Bryon Merade and others.
This is the patent Samantha fell under in April 2004, when she was implanted by one of the coinventors of the Caldera implant method who shared in its patent and profits. Women with hysterectomies, had no uterus and it is core element of the entire patent process to place the tape between the uterus and vagina. This is why in many women the device migrates and does not remain in place, due to placing in women with no uterus.
The internal obturator muscle, obturator internus muscle originates on the medial surface of the obturator membrane, the ischium near the membrane, and the rim of the pubis. It exits the pelvic cavity through the lesser sciatic foramen. The internal obturator is situated partly within the lesser pelvis, and partly at the back of the hip-joint.
There are eight incisions, entry and exit woulds which result in the Sciatic and pudendal internal damage, all from the patented implant method. “This is how the harm occurs,” Samantha say and its profound and life-altering.
Samantha writes in her recent claim to Chubb, “There really seems to be a blindness to Chubb, not believing that eventually this is going to grow into numerous claims for Chubb insured Transobturator Surgical Mesh Implant Intellectual Property Medical Method Harm. There are now women years after removal having urethral and rectal diverticulums due to the mesh migration, embedding and erosion. This IP Method is a multi party claim. The fraud, is Chubb knows their is more than one party they insure who are collectively at fault for this harm.”
The Chubb insurance policy says there could be upward of $5 million to $10 million per occurrence for damage from TVT-O products. However they contend all 4,000 claimants are one occurance.
She and the other women want an Emergency Motion to Stay Due to a Criminal Investigation, which could include insurance fraud, human rights violations, experimental procedures, and Stark’s Law violations where an implanting physician has an ownership of the product.
SO WHAT YOU CAN DO – A MOTION TO STAY
A Motion to Stay the Caldera Final Approval would allow time for the Attorneys General of both Washington State and California to conduct an investigation, civil and perhaps criminal, says Samantha.
Recently, Attorneys General in both Washington State and California filed civil lawsuits against Johnson & Johnson for deceptive marketing of surgical mesh products. California AG Kamala Harris said other defendants may be added, who also deserve to be charged with consumer fraud. See the California complaint here. See the Washington State complaint here.
Here is a letter suggested by Samantha.
Dear Attorney General Kamala Harris and Attorney General Bob Ferguson:
I have had life altering injuries due to the Deceptive Marketing of Surgical Mesh Products of Caldera Medical, Inc.
AG Harris said she will be adding future defendants who also committed consumer fraud. J&J is the first medical device company. This is a request to make Caldera the second device company for people who are injured in the state. Boston Scientific, J&J, Caldera, Bard, Cook all brought the transobuturator surgical mesh to market. All are implicated through their shared financial gains for these patents and should be added to the AG complaints.
Chubb insures all parties for these patents and they pretend these general, overlapping life science policies do not exist. The first 8 incisions and the entire entry wounds which result in Sciatic and Pudendal Internal damage is all Intellectual Patent Medical Method harm, brought to market by these four major device manufacturers. The damage and harm is profound and life-altering.
They are also tied to Johnson and Johnson through the Deceptive Marketing of Transobturator Surgical Mesh Implant Method. The US6638211 Patent ties Johnson, Mentor Worldwide L.L.C., Ethicon, American Medical Systems, Inc. and Caldera Medical, Inc. together as this Intellectual property of the first eight medical methods are necessary for all of these companies products to implant these devices.
Methods and devices for placing the implants do not minimize trauma to the pelvic floor and do not provide well-anchored support to pelvic organs without interfering with sexual or other bodily functions. I have sexual harm and bodily harm. It is undeniable that Johnson and Johnson, Mentor Worldwide L.L.C., Ethicon, American Medical Systems, Inc. and Caldera Medical, Inc. are all responsible for the injuries suffered by Caldera Medical, Inc.’s victims.
Although I am writing from a different State (if applicable), you need to add Caldera Medical Inc to your lawsuit and investigation because of the injured women in California and Washington State.
The Transobturator Surgical Mesh Implant Intellectual Property Medical Method claims that the methods and devices for placing the implants minimize trauma to the pelvic floor and provide well-anchored support to pelvic organs without interfering with sexual or other bodily functions. I confirm they do not and cause sexual function harm and bodily function harm.
http://www.meshmedicaldevicenewsdesk.com/caldera-final-appeal-deadline-facing-opposition/
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European Union Cracks Down on Toxins in Plastic Used for Medical Devices
Jun 12, 2016 | Mesh Medical Device News Desk
Mesh Medical Device News Desk, June 13, 2016 ~ Using Plastic for Permanent Implants Is Not the Ideal Material
Mr. McGuire: I just want to say one word to you – just one word.
Ben: Yes sir.
Mr. McGuire: Are you listening?
Ben: Yes I am.
Mr. McGuire: ‘Plastics.’
Ben: Exactly how do you mean?
Mr. McGuire: There’s a great future in plastics. Think about it. Will you think about it?
Ben: Yes I will.
By the time young Dustin Hoffman was being schooled on his future in the 1967 film, “The Graduate,” the medical industry had discovered plastics.Derived from the Greek word, “plastikos,” meaning to mold or form, plastics had an advantage over steel, ceramics and glass for medical use. Besides being pliable and implantable, plastics were cheap to produce and easy to dispose of avoiding cross-contamination in hospitals.
Derived from oil refineries generating many units of carbon, oxygen and hydrogen, by midcentury, production techniques allowed plastics to be molded into medical devices including those implantable – heart valves, stents, pacemakers, defibrillators, silicone implants, hip and bone implant components and hernia and pelvic mesh, to name a few.
In 2013, the global market for polypropylene (PP), a cheap commodity plastic, was about 55 million metric tons. PP has a wide range of applications. In the laboratory is can withstand the heat in an autoclave, so PP was easily adapted as suture material.
But problems with plastics are mounting.
While tests showed their endurance when interacting with oxygen, there was very little evidence of how they did constantly exposed to liquids, especially bodily fluids.
That’s a problem for 600,000 people worldwide who have pacemakers implanted and the 100,000 patients who receive defibrillators in the US each year.
When researchers in 2012 mimicked conditions inside the human body, they found materials began to break down within three to six years, including plastic used to coat cardiac leads that carry an electrical current from the battery to the heart. Water caused the plastic to age, soften or lose tensile strength, according to a study, published by the American Chemical Society.
Polypropylene has been used as hernia mesh since the 1950s and more recently implanted as a permanent implant in women with urine leakage or sagging pelvic organs. It too is now believed to change in the body in the presence of bodily fluids and heat with dire results for hernia and pelvic mesh recipients.
Initially marketed as inert, in 2011, Dr. Donald Ostergard, past president of the American Urogynecologic Society,published an article revealing information accumulating since the 1950s. Mesh is not inert, he wrote, the PP was able to incite an inflammatory response or foreign body reaction. Electron microscopy showed the deep cracks in the PP as it degrades in the body as well as shrinks 30 to 50 percent.
More than 100-thousand defective product lawsuits have been filed by women experiencing mesh complications.
Eto used to sterilize TVT Secur
What’s equally concerning, PP mesh implants are exposed to ethylene oxide (EtO), a low-temperature sterilization agent. EtO is regarded by the EPA as toxic and a carcinogenic and exposure is regulated by the EPA, and in the workplace, under the rules of the Occupational Safety and Health Administration (OSHA).
Two standards are supposed to assure the implant sterilization is safe for humans and the implants are biocompatible. But the ISO 10993 and United States Pharmacopoeia USP Class VI only go so far. According to Plastics in Medical Devices, Second Edition, “It would be possible to pass the USP Class VI test while still showing up as cytotoxic, mutagenic, hemolytic, or sensitizing in the biological testing.”
On May 24, 2016, a compromise deal in the European Union promised to step up surveillance of implanted medical devices. The deal, agreed to by the European Parliament and EU Council of Ministers, would limit the use of devices that contain carcinogenic, toxic, mutagenic or have hormone disrupting properties, including plastics.
Any device that is implanted and comes in direct contact with the human body containing those properties will be barred unless the proportions do not exceed 0.1 percent by weight. Consumers and doctors will be informed through strict labeling requirements.
The crackdown comes following a scandal in the EU in 2011 when a French manufacturer used industrial grade silicone in breast implants.
In the EU, a central database will list all devices on the market that are implanted.
The U.S. has yet to establish a national database for adverse events when plastic medical devices go wrong. ##
http://www.meshmedicaldevicenewsdesk.com/european-union-cracks-plastic-medical-devices/
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Labour calls for more scrutiny of surgical mesh
Jun 11, 2016 | Newshub
By Mike Wesley-Smith
Labour has asked the health and disability commissioner to launch an investigation into the use of surgical mesh, after two women launched a commission of inquiry.
Charlotte Korte and Carmel Berry, both sufferers of chronic pain caused by the surgical mesh; have been campaigning for tougher regulation around the use of such devices.
Last week, the select committee reported back, urging the Government set up a mesh registry.
The committee also suggested ongoing campaigning for mesh removal and an expansion of regulator Medsafe's capability to assess the safety of medical devices.
As for a wider inquiry, the answer was no.
With the recommendations now with Government, Labour deputy leader Annette King says the report doesn't go far enough and is demanding further scrutiny.
The implant itself looks harmless, made from polypropylene and designed in the 1950s to mend abdominal hernias.
Since its conception, surgical mesh has made its way into more intimate procedures -- including operations designed to support or hold in in women's pelvic organs and to treat pelvic-organ prolapse.
Christine Williams was treated with mesh -- resulting in her enduring agonising pain for 32 weeks.
"I had the surgery and woke up in pain in recovery, and haven't basically been able to sit on my left-hand side."
Since the operation in 2013, Ms Williams has not been able to work due to the chronic pain.
She says if she had known the risks associated with mesh prior to the surgery, she'd have never gone ahead with it.
"It's like Russian roulette," she says.
The mesh remains inside Ms Williams and she has been unable to find a surgeon in New Zealand who can remove it, because the procedure is so complicated.
While the operation can be performed in North America, ACC won't fund it.
Canadian surgeon Robert Bendavid has performed thousands of hernia surgeries in his 30 years of experience and has studied mesh extensively.
"I certainly wouldn't want to expose my children, my daughters to this sort of a problem, ever," says Dr Bendavid.
He has grave concerns with mesh because of the way it can degrade in the human body.
"The real problem is that it has a tendency to erode into tissues and of course, erosion into bowel or erosion into muscle. Erosion into a vain or artery can be a very problematic situation," says Dr Bendavid.
A Canadian study found that degrading mesh could cause nerve and organ damage and research has concluded that the devices were "introduced with incomplete understanding of mesh-body interactions".
The figures state between 12 and 17 percent end up with chronic pain -- and abdominal wall hernias seem to be similar with the pelvic use in vaginal operations.
Experts here put the number experiencing pain at about nine percent, but say this figure could be underreported.
When contacted by the Nation programme, the Royal College of Gynaecologists, whose surgeons work with mesh in New Zealand, couldn't make anybody available for interview.
They did say via statement that degrading mesh was a continuing area of research which the college is watching carefully, and it believes there is still a role for surgical mesh use in patients, particularly for incontinence procedures.
The college also pointed out that pain can occur following surgeries which don't use mesh too.
Ms Williams is one of 500 mesh recipients who have filed successful treatment injury claims with ACC over the last decade.
More than $10 million has been paid out by ACC for rehabilitation and compensation.
In an ACC report, more than 56,000 mesh devices had been sold as of 2014.
The ACC claim rate for mesh used during organ prolapse repair was five times that of other procedures.
However, as the report also noted it is possible that other individuals have suffered complications related to the use of surgical mesh but have not lodged a claim with ACC.
Regulator Medsafe claims that mesh is safe when used by properly trained surgeons and that the benefits outweigh its risks.
It is a position that is consistent with overseas authorities and Medsafe says depending on the type of surgery involved, problems with mesh implants can occur in zero to 15 percent of cases.
The use of mesh has been declining, but the damage it has left behind has not been forgotten.
http://www.newshub.co.nz/nznews/labour-calls-for-more-scrutiny-of-surgical-mesh-2016061111#ixzz4BRJDPAEC -
NZ First calls for halt to the use of surgical mesh
Jun 12, 2016 | Voxy.co.nz
New Zealand First is calling for a halt to the use of surgical mesh until it is proven to be safe.
"The government should have stopped the use of surgical mesh at the first signs of severe complications - people must come first, not dollars," says New Zealand First Leader and Northland MP Rt Hon Winston Peters.
"Decisive decision making was needed but, instead, more and more patients had mesh implanted for hernias and organ prolapse.
"Hundreds of claims have been made to ACC and many normal lives ruined because recipients are in constant pain. They should not have been condemned to lives in agony.
"When a New Zealand surgeon specialising in mesh removal says that it is complicated, and that transvaginal mesh for women patients should not be used, the government should listen.
"If there is ongoing surgery, no amount of reviews, investigations and inquiries will protect new patients from complications.
"To place the decision for surgery on them, as recommended, is asking them to dance on thin ice," says Mr Peters.
http://www.voxy.co.nz/politics/5/254240
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