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Ethicon 24/05
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J&J settles pelvic mesh appeal before Texas Supreme Court
May 23, 2016 | Reuters
By Jessica Dye
Johnson & Johnson and its Ethicon unit have reached a settlement in a lawsuit currently on appeal before Texas' highest court over whether a $1.2 million verdict for a woman claiming to have been injured by a defective pelvic mesh device had been wrongly overturned -
Study: Insufficient Science to FDA Allows Med Devices On the Market
May 23, 2016 | Mesh Medical Device Newsdesk
The U.S. Food and Drug Administration (FDA) has put safety in the back seat in approving several high risk devices for obstetric and gynecological procedures, according to a study by researchers at Northwestern University. -
Autoimmune Registry Continues to Grow with Mesh-Related Complications
May 23, 2016 | Mesh Medical Device Newsdesk
The autoimmune registry and alive and there have been so many comments, it is being posted again so you can continue to comment. -
Open Letter to Insurers Concerning Mesh Injuries
May 23, 2016 | Mesh Medical Device Newsdesk
Often readers of Mesh News Desk find themselves fighting with the very insurance companies that led them to a mesh implant doctor. Now they want the device removed and they receive resistance. Not only because there are very few doctors well versed in mesh-removal surgery but even if they find someone, their insurance will not cover it!
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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J&J settles pelvic mesh appeal before Texas Supreme Court
May 23, 2016 | Reuters
By Jessica Dye
Johnson & Johnson and its Ethicon unit have reached a settlement in a lawsuit currently on appeal before Texas' highest court over whether a $1.2 million verdict for a woman claiming to have been injured by a defective pelvic mesh device had been wrongly overturned.
The Texas Supreme Court issued a brief order Friday saying it had been notified by lawyers for J&J and plaintiff Linda Batiste that they had reached an agreement in principle to resolve the case. Terms of the settlement were not made available.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/27QSsT1
http://www.reuters.com/article/products-mesh-appeal-idUSL2N18K1VD
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Study: Insufficient Science to FDA Allows Med Devices On the Market
May 23, 2016 | Mesh Medical Device Newsdesk
The U.S. Food and Drug Administration (FDA) has put safety in the back seat in approving several high risk devices for obstetric and gynecological procedures, according to a study by researchers at Northwestern University.
Citing the problems with transvaginal mesh, power morcellators, and the Essure birth control device, researchers reviewed the 18 medical devices approved by the obstetrics and gynecology advisory committees of the FDA between January 2000 and December 2015.
Focusing on the devices with the highest potential risk to patients, they found many made it to market based on flawed data from studies that were either too small or too short. They conclude they should have undergone more rigorous pre-approval and post-approval scrutiny.
Devices include those for Endometrial Ablation (33%), where menstrual flow is reduced; contraception (28%), such as Essure, a permanent sterilization device was approved after short-term evidence and insufficient post-market follow-up; and 17% were for fetal monitoring.
Northwestern Researchers Steve Xu MD and Jessica Walter MD
“Transvaginal meshes and laparoscopic morcellators are two devices cleared through the less stringent 510(k) pathway of the FDA which requires little to no additional clinical evidence or postmarketing surveillance before clearance. Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with both devices, it may have provided earlier warning of patient safety risks.”
The information comes at a time the 21st Century Cures Act is under consideration by the Senate after passing the U.S. House of Representatives this month. It contains provision that would further reduce medical device regulation by widening what is considered “valid scientific evidence.”
BACKGROUND
Dalkon Shield was approved in the 1970’s had a string that was a pathway for bacteria leading to infertility and infection, septic abortions and death. The dangerous device was the basis of passage of the 1976 Medical Device Amendment which granted the FDA authority to regulate medical devices.
Unlike drugs, the approval process for the majority of medical devices, even those permanently implanted, do not require clinical trials, randomized controlled trials or even post-market surveillance.
Meanwhile, drugs must undergo premarket approval which includes clinical trials involving humans.
Essure birth control device removed
THE FDA DEVICE REVIEW
Since approval of the 18 devices, the Northwestern researchers found three have been withdrawn from the market, two of which had failed to show efficacy in their clinical trials (fetal monitors, noninvasive). One was not required to be monitored after approval and removed from market because of patient safety concerns.
During this review, one-third of the 18 devices were not required to undergo postmarket review or studies. Of the devices, 42% were approved based on nonrandomized controlled trials ranging from three to 48 months.
Four devices were approved even though they failed to demonstrate efficacy in clinical trials.
The advisory committee recommended 9 devices for approval and recommended three devices not be approved. The committee recommended against approval of both the Stan S31 Fetal Heart Monitor and the LUMA Cervical Imaging system.
The median approval time was 290 days from application to market.
Intergel, made by Gynecare Worldwide (J&J), was an adhesion prevention gel solution put in an open abdominal cavity to keep tissues from sticking together during the healing process. After two years on the market, Gynecare Intergel was withdrawn April 16, 2003 here due to reports of serious foreign body reactions and postprocedure pain.
The committee recommended against approval of Intergel which did not demonstrate significant differences compared with its control. During its review, Intergel required no additional postmarketing studies outside of adverse event reporting.
Essure, a permanent birth control device, is currently undergoing increased regulatory scrutiny as a result of complications reported to the Manufacturer and User Facility Device Experience database (MAUDE).
Essure’s approval was based on a prospective single arm study with a primary outcome of pregnancy at one year. It was approved through the premarket approval pathway “with insufficient long-term evidence and postmarket surveillance requirements” say researchers.
The researchers conclude there are “significant weaknesses” in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices. They recommend more rigorous clinical studies before and after devices make it to market.
“The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” says Dr. Steve Xu the lead researcher.
The study is published in the journal Obstetrics and Gynecology, May 4, 2016, here.
While industry argues that more regulation will slow innovation, the researchers say there is limited evidence to support that assertion.
http://www.meshmedicaldevicenewsdesk.com/insufficient-fda-reviews-allow-med-devices-market/
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Autoimmune Registry Continues to Grow with Mesh-Related Complications
May 23, 2016 | Mesh Medical Device Newsdesk
The autoimmune registry and alive and there have been so many comments, it is being posted again so you can continue to comment.
The registry is being considered by medical researchers so your imput it vital. If you have any kind of mesh, pelvic, abdominal, hernia and have experienced auto immune issues afterward, please add your comments. The registry is the brainchild of Hope Pagano and you may have read her profile(here) on the pages of Mesh Medical Device News Desk.
Hope, the mother of six and wife to Steven, developed Lupus after her implant of an Ethicon/ Johnson & Johnson TVT-Abbrevo sling.
Besides pain and chronic infections, following her May 13, 2011 surgery, Hope developed symptoms which included fever, muscle fatigue, muscle aches, headaches, sensitivity to light and sound and brain fog. Within eight months she was diagnosed through double stranded DNA (ds-DNA) and an ANA test revealed full blown Lupus.
Lupus is an autoimmune disease that means the body is attacking itself in some form. Essentially it is fighting off a foreign invader. See more from the Lupus Foundation of Americahere.
Hope Pagano wants others, who have also developed autoimmune issues following their implant, to add their names to this registry. Include the symptoms that developed after a mesh implant and how soon after. You might also include the name and manufacturer of your mesh.
“There is strength in numbers,” she says. “Only with proof in numbers will this be taken seriously.”
http://www.meshmedicaldevicenewsdesk.com/autoimmune-registry-continues-grow-mesh-related-complications/
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Open Letter to Insurers Concerning Mesh Injuries
May 23, 2016 | Mesh Medical Device Newsdesk
Often readers of Mesh News Desk find themselves fighting with the very insurance companies that led them to a mesh implant doctor. Now they want the device removed and they receive resistance. Not only because there are very few doctors well versed in mesh-removal surgery but even if they find someone, their insurance will not cover it!
You do not want an amatuer trying to remove mesh impacted int the body. Very few doctors actually have the experience to even be able to assess these complications to determine if the mesh needs to be removed. If so, it’s a sensitive and delicate operation that should not be undertaken by anyone but an experienced mesh removal doctor.
As there is more and more awakening to mesh dangers and complications, insurers too need to be brought up to speed. The following letter is one a woman can use to address her insurance company when it fails to recognize the seriousness of her complication and refuses to support her decision to seek out one of the few mesh removal experts in the U.S.
Here is a suggested Open Letter to insurers to help them gain some understanding of this mesh mess.
To Whom It May Concern-
I’m writing as a mesh-injured woman who is desperately trying to seek help from a doctor experienced in mesh-related injuries. This might include a urologist or urogynecologist who has experience in removing pelvic mesh that has migrated, eroded, broken apart, perforated organs, folded, frayed and perforated nerves, not to mention the systemic issues such as autoimmune disease that often erupts after being implanted with polypropylene pelvic mesh.
There are very few competent medical doctors around the country who are dealing with the hundreds of thousands of women who are now experiencing the complications from this mesh. Through the mesh-injured community, we are becoming aware of these doctors.
I am seeking a referral to a doctor who has experience in removing polypropylene mesh from the pelvic region, not just the closest and most cost-effective for the insurance company. This may be a matter of life or death – mine.
As you know this mesh was implanted in me and thousands of others to hold up pelvic organs that may be falling through the vagina. Like thousands of others, it has only caused problems that can be described as life-altering. As I write this, the mesh is migrating toward my bowel, a condition that can lead to fatal sepsis (this is one example, use your own).
There are currently at least 120,000 lawsuits filed against mesh manufacturers for marketing a defective product without any FDA clearance for safety and efficacy. These are not lawsuits generated by hysterical women. The injuries are real and not imagined. In many cases they are permanent.
Juries across the country have determined that pelvic mesh was defectively designed, yet many meshes remain on the market. Some doctors still mistakenly refer to them as the “Gold Standard.” Clearly marketing and medicine have married to create this huge disconnect. No Gold Standard would wound so many. Remember it was frequently the insurance companies that led women to doctors who implanted these products. Doctors have admitted on the stand they were unaware of the dangers and had been made false promises by sales reps from the major mesh makers.
All of the problematic mesh, whether for prolapse (POP) or incontinence (SUI) is made from polypropylene and they are all substantially similar. They were all approved by the Food and Drug Administration as substantially equivalent to a “predicate device,” the ProteGen, which was eventually taken off the market for being defective.
I should not be in this position. I should never have had mesh implanted for a condition, not a disease. I should have received true informed consent. I did not. There are safer alternatives that have been known for decades, before mesh manufacturers began coaching doctors on this new “minimally-invasive” technique that would yield them greater profits in the shortest amount of time.
Insurance companies supported this procedure we now know was experimental and never underwent clinical trials for safety. I should never have to beg for my insurer to send me to the proper professional who very well may save my life.
But that is where I find myself.
A friend recently made signs and, along with supporters, petitioned in front of the insurers’ hospital to receive a referral to UCLA’s urology department, considered the most experienced in the world for mesh removals. Within about 20 minutes, she received that referral. Is that what it takes?
I remain adamant that I receive a referral to the specialist of my choice based on the recommendations of others who have had successful mesh removals. Together we can work on determine the best doctor to address my problems, as soon as is reasonably possible.
I encourage the insurance company to gain a better understanding of the breadth of the problem because women are requiring multiple surgeries when the first doctor, the one closest to the patient who is the most cost-effective, may leave remnants of polypropylene behind to wreak havoc, migrate, shrink and continue to incite a foreign body response. That creates a “ticking time bomb” as the long-term effects have never been studied in clinical trials. We are essentially the lab rats.
As is typical, one partial removal leads to another and then another adding unnecessary cost to the insurer and a burden to my quality of life. Isn’t it preferable to get the best surgical outcome in as few surgeries as possible?
Since insurers initially paid for these mesh implants, it is now time to step up and do the right thing- cover explant surgeries by reliable, experienced surgeons.
Please advise me on the next step needed. I look forward to talking further with your representatives who have direct authority over my case and have the authority to issue a referral. Time is of the essence here.
To deny them the proper medical care adds insult to these horrendous injuries.
Sincerely,
(your name here)
I am supplying you with stories that will back up my assertions here. Please read them and become knowledgeable about this issue.
http://www.meshmedicaldevicenewsdesk.com/open-letter-to-insurers-concerning-mesh-injuries/
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