Preview Newsletter
Ethicon Media Monitoring 9/19/2017
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Vaginal mesh victims to go before NSW Senate
Sep 19, 2017 | Sky News
A woman who has suffered crippling pain from a vaginal mesh implant has told senators of the living nightmare her life has become. -
Vaginal mesh victims share tales of pain
Sep 18, 2017 | AAP (In SBS)
Harriett used to begin her busy days at 5am to get her five little people out the door. -
Pelvic Meshes Removed from Australian Market
Sep 19, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 18, 2017 ~ A Senate inquiry continues in Australia today and Tuesday as Johnson & Johnson and Boston Scientific present evidence on the safety and efficacy of the pelvic mesh devices. -
Talking About Women’s Intimate Health Can Improve Your Life
Sep 18, 2017 | Boston Magazine
By Metrocorp
Karen Perry was caught off-guard when she started experiencing gynecologic issues that she thought only happened to “older” women. -
Irish women take legal action over 'razor blade' vaginal mesh implants
Sep 18, 2017 | thejournal.ie
A NUMBER OF Irish women are pursuing legal action over complications they suffered after receiving vaginal mesh implants. -
Canada has a 'big blind spot' on medical device safety: study
Sep 18, 2017 | CTV News
A new study has found more than 7,200 medical devices were recalled in Canada between 2005 and 2014, ranging from hospital beds to major joint implants to hernia mesh. -
FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices
Sep 18, 2017 | Mesh Medical Device Newsdesk
The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market. -
Johnson and Johnson Must Pay $57M in Pelvic Mesh Case
Sep 18, 2017 | The Legal Reader (blog)
By Jay W. Belle Isle
Ella Ebaugh, a resident of Pennsylvania, knows about pain. She was diagnosed with stress urinary incontinence (SUI) in 2005.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Vaginal mesh victims to go before NSW Senate
Sep 19, 2017 | Sky News
A woman who has suffered crippling pain from a vaginal mesh implant has told senators of the living nightmare her life has become.
NSW woman Gai Thompson is one of a dozen women to appear before a Senate inquiry in Sydney on Monday.
Ms Thompson told the inquiry of severe complications she's suffered since the surgery including excruciating and chronic pain, losing three pints of blood, multiple autoimmune diseases and the inability to have sex.
'When the doctor told me I would no longer be able to have sex with my husband, he said there was more than one way to skin a cat,' Ms Thompson told AAP.
The women are among 800 involved in a class action lawsuit against Johnson Johnson, claiming the vaginal mesh implants have left thousands in pain.
Johnson Johnson managing director Gavin Fox-Smith told senators it was incredibly tough to hear stories from women in pain or suffering.
However, he said stress urinary incontinence and pelvic organ prolapse were complex conditions and surgical intervention remained an important treatment option.
Mr Fox-Smith said most patients had experienced good long-term results.
'Unfortunately in dealing with a human body no technique, instrument, approach or product is without some risk,' he told the inquiry.
Johnson Johnson maintains it has acted ethically and responsibly in the research, development and supply of its products.
The company discontinued two pelvic mesh devices from the Australian market after the Department of Health asked for more information to be added to the instructions for use of the products.
Mr Fox-Smith said Johnson Johnson was still confident in the safety and efficacy of the products, and its decision was based on their 'commercial viability'.
'The costs of making such a change only for the Australian market exceeded the total value of sales for those products in 2016,' he said.
Ms Thompson received a mesh implant nine years ago in a bid to repair her damaged pelvic floor.
Just three years later, she approached Australia's Therapeutic Goods Administration to warn of a looming disaster involving the device.
While the particular mesh implanted into Ms Thompson - Prolift Pelvic Floor Repair System by Johnson Johnson - has been taken off the market, there are still surgeons in Australia who are implanting vaginal mesh in women.
'While I'm speaking to you now I can guarantee there is a woman in a Sydney hospital somewhere having mesh put inside her and not realising,' she said.
Having visited 13 different surgeons in Australia, Ms Thompson is yet to find one willing to remove the permanent mesh implant.
The Senate inquiry into the devices will hold a public hearing in Canberra on Tuesday.
http://www.skynews.com.au/news/national/nsw/2017/09/18/vaginal-mesh-victims-to-go-before-nsw-senate.html
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Vaginal mesh victims share tales of pain
Sep 18, 2017 | AAP (In SBS)
Harriett used to begin her busy days at 5am to get her five little people out the door.
Now the mother from Brisbane says she relies on medication so she can simply smile at her children through the pain of having had a transvaginal mesh implant.
She was one of four women who publicly shared their experience to a Senate committee in Canberra on Tuesday.
Harriett's surgeon told her he could fix her stage four pelvic organ prolapse and she would be "like a 16-year-old again".
Instead complications have meant it has since been partially removed and she is left with the shooting pain of nerve damage.
"I now have pain every day of my life. Not intermittent pain, forever pain," she told the committee.
Suffering post-traumatic stress disorder, anxiety and now depression, Harriett faces going without doctors appointments so she can pay for school fees.
"The pain slowly kills your soul. You cannot concentrate, stop it or run from it," she said.
"It never goes away."
Stephanie from regional Queensland was assured her surgery had a high success rate, but has also been in intense pain ever since.
She was grateful for the Senate committee but is angry its inquiry is needed.
"It is hard enough to endure such suffering without having to share the most intimate and personal details to the world," she said.
Toni from regional NSW, who had her implant in 2014, said one bit of good news for her is that she's been able to get a disability status under the new NDIS.
The hearings come as 800 women fight in a class action lawsuit against Johnson & Johnson, claiming their vaginal mesh implants have left them in pain.
The company's managing director Gavin Fox-Smith told senators on Monday it was incredibly tough to hear stories from women in pain or suffering.
However, stress urinary incontinence and pelvic organ prolapse were complex conditions and surgical intervention remained an important treatment option, he said.
The company maintains it has acted ethically and responsibly in the research, development and supply of its products.
Two of its pelvic mesh devices have been removed from the Australian market after the Department of Health asked for more information to be added to the instructions for their use.
The Australian Commission on Safety and Quality in Healthcare told Tuesday's hearing work on a guidance for patients will be released in coming months.
The commission's Dr Robert Herkes said the rate of complications for mesh implants due to pelvic organ prolapse was at least 15 per cent and maybe up to 30 per cent.
Complications for stress urinary incontinence is much lower at about two to five per cent.
http://www.sbs.com.au/news/article/2017/09/19/vaginal-mesh-victims-share-tales-pain
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Pelvic Meshes Removed from Australian Market
Sep 19, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 18, 2017 ~ A Senate inquiry continues in Australia today and Tuesday as Johnson & Johnson and Boston Scientific present evidence on the safety and efficacy of the pelvic mesh devices.
Meanwhile two meshes have been removed from the Australian market.
Joanne McCarthy a reporter for Australia’s The Herald newspaper, writes Johnson & Johnson (J&J) has withdrawn two of its controversial pelvic meshes from the Australian market after feds asked for more evidence of device safety.
Instead of a quiet recall from the market, J&J told a Senate pelvic mesh inquiry in that country that it had “decomercialized” the Gynemesh Prolene and Gynemesh PSXL. The meshes are made of polypropylene and are a bridging material for apical vaginal and uterine prolapse.
The instructions for use, the warning brochure within the package, had become cost costly to change.
Australia’s version of the U.S. Food and Drug Administration, the Therapeutic Goods Administration (TGA) required changes in the instruction brochure for the product.
“The costs of making a change only for the Australian market would exceed the total value of the sales of the product for 2016,” the company said in a statement. J&J denies this is a recall and says the company “continues to have confidence in the safety and efficacy of these products,” the article quotes J&J as saying.
There will be a public hearing Monday at the Parliament House in Sydney and another at the Canberra Parliament on Tuesday, all part of an inquiry by Victorian Senator Derryn Hinch.
He has called the pelvic mesh debacle “one of the greatest medical scandals and abuses of mothers in Australia’s history.”
Johnson & Johnson and Boston Scientific will be present to give evidence on the Monday inquiry.
See Women Speak of Horror of Vaginal Mesh Implants story today here.
The devices were cancelled from the TGA registry August 22.
McCarthy reports in 2013 there were 100 different mesh devices manufactured by 42 companies on the TGA register. Last month there were just nine mesh device companies making 22 mesh devices.
There are more than 700 Australian women who are in the midst of a six month class action lawsuit being heard in a Sydney courtroom.
J&J is facing more than 55,500 pelvic mesh product liability lawsuits filed around the globe, according to its recent SEC report. ###
https://www.meshmedicaldevicenewsdesk.com/pelvic-meshes-removed-australian-market/
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Talking About Women’s Intimate Health Can Improve Your Life
Sep 18, 2017 | Boston Magazine
By Metrocorp
Karen Perry was caught off-guard when she started experiencing gynecologic issues that she thought only happened to “older” women. Two years ago,, at 43 years old, Karen developed stress urinary incontinence and poor lubrication in the vaginal walls. Not feeling comfortable enough to discuss it with her primary care physician or OB/GYN, she kept it quiet and silently dealt with the discomfort.
“When I sneezed, I often had to cross my legs,” says Karen. “I thought I was far too young to be experiencing these symptoms, but I ended up having to wear a pad.”
A vaginal sling procedure is typically recommended to treat stress urinary incontinence. During the procedure, a surgeon uses strips of synthetic mesh or your own tissue to create a sling or “hammock” under the tube that carries urine from the bladder (urethra) or the area of thickened muscle where the bladder connects to the urethra. The sling supports the urethra and helps keep it closed — especially when you cough or sneeze — so that you don’t leak urine.
“I thought about getting the mesh surgery, but I didn’t really want surgery,” Karen says. “I did a little bit of research about other treatment options, but I ended up just putting it in the back of my head and not dealing with it.”
Recently Karen, an Administrative Coordinator at Beth Israel Deaconess Medical Center (BIDMC), heard about the new Center for Intimate Health and Wellness opening at BIDMC. The Center uses a holistic, multidisciplinary approach to treat women with intimate health and wellness issues. Karen was one of their first patients.
“We recommended vaginal resurfacing as a course of treatment for Karen’s stress urinary incontinence and poor lubrication,” says Dr. Roger Lefevre, MD, Director of the Center for Intimate Health and Wellness. “We use a special laser – three treatments are needed over the course of three months and each session only lasts about four to five minutes. Most patients start to see an immediate change.”
Karen has only had one treatment, but is already recommending it to friends and family. She said the laser treatments are painless and only slightly uncomfortable and she has nothing but good things to say about the treatment.
“The whole experience from working with the office staff to the moment I left the facility has been superb,” Karen says. “I was treated like a VIP and I know Dr. Lefevre does that for all his patients. He has this amazing ability to connect with his patients and make you feel completely comfortable.”
Karen has since learned that intimate health issues are more common among women of all ages than she once thought. She encourages women to speak to their doctor about their concerns.
“My biggest fear was I didn’t think other women were going through this,” Karen says. “But don’t think you’re the only one – there are lots of women dealing with these issues. Don’t be scared. I think back now and realize how silly it was that I didn’t want to address it.”
Karen still has two treatment sessions ahead of her, one in September and one in October, and might need maintenance sessions over time. But she’s very happy with the results she has seen thus far.
“In addition to the stress incontinence, the other issue definitely presented its challenges,” Karen says of the poor lubrication. “I’ve been with my husband over 18 years and intimacy is a really important part of a relationship and this was kind of a bonding experience for both of us. I did it for myself, but I did it for my relationship, as well.”
For more information on women’s health, turn to Beth Israel Deaconess Medical Center by visiting www.bidmc.org.
This post is a sponsored collaboration between Beth Israel Deaconess Medical Center and Boston magazine's advertising department.
http://www.bostonmagazine.com/sponsor-content/talking-women-intimate-health-can-improve-life/
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Irish women take legal action over 'razor blade' vaginal mesh implants
Sep 18, 2017 | thejournal.ie
A NUMBER OF Irish women are pursuing legal action over complications they suffered after receiving vaginal mesh implants.
The cases have emerged following reports of thousands of patients in the US, UK and Australia enduring similar issues with the devices.
Transvaginal mesh implants are used to treat stress incontinence and more recently pelvic prolapse – when a pelvic organ such as the bladder drops. Both of these conditions are common in women after childbirth. The mesh, a net-like implant, which comes in a number of forms and sizes, is inserted in order to support the weakened organ. Tissue then grows into the pores of the mesh to fortify the walls of the affected organ.
These devices have been used across Europe, the United States and Australia since the early 2000s and while short-term trials have found low complication rates for implants that are used to treat stress incontinence, there is growing evidence that the efficacy is lower for devices used in women with pelvic prolapse – and complication rates are higher.
The US Food and Drug Administration reclassified the transvaginal mesh implant as a high-risk device in 2012 and some 100,000 women there have filed lawsuits, but it is only in recent months that the issue was highlighted in the UK.
Legal representatives for women in Ireland who have undergone the procedure have said it was on seeing reports in the UK that some of their clients made the connection between their health issues and the device.
Pain, which is now believed to be related to the implants, can begin at any time – even years – after the procedure. The devices are still in use in Ireland though guidelines have been issued to clinicians in recent years.
‘Like a razor blade inside you’
Issues reported by women include headaches, lack of energy, discharge, bleeding and pain – which some have said was so intense they were unable to walk. Many have also reported being unable to have sex long after having the procedure. In some cases, the device cut into their vaginas or damaged other organs.
NHS data provided to The Guardian recently suggests that one in 15 women in the UK who underwent this procedure later had to have the implant either partially or fully removed. More than 800 women are now suing the NHS and manufacturers of the mesh implants.
The Scottish government has asked health boards to suspend the use of mesh devices.
A survey by consumer advocacy group Health Issues Centre in Australia this year found 59% of women said the procedure did not resolve their original issue and 58% reported experiencing pain during sexual intercourse after having the mesh inserted. A Senate inquiry into the issue has been launched in Australia with a hearing due to take place today.
In a submission to this inquiry, one 72-year-old woman wrote that she suffered for 14 years after having the implant inserted to repair a tear in the wall of her vagina.Pain is with you all the time, I have infections and discharge and I’ve had four erosions, which put me in the hospital where the surgeon removed pieces of the mesh each time. I can feel the mesh when it moves it feels like a razor blade inside you … the doctor said if I start haemorrhaging to go straight to a hospital. I hope I get rid of this mesh one day. I’d be a very happy, healthy 72-year-old and have a normal life, what’s left of it for me.
‘Harrowing’
Now a number of Irish women affected by the issue are pursuing legal action – some against manufacturers and others against individual clinicians.
Solicitor Melanie Power is representing three of these women, though she told TheJournal.ieshe has been contacted by around 25 people in total who have had the implants and who suffered “unidentified pain”.
“It really is a case of people not knowing what is causing their problems and they are just putting up with it in a real Irish mammy way. They think this is what happens when you have a baby. And some people are just embarrassed to talk about it,” she said.
Power said she has heard some “harrowing accounts” from some women who have contacted her.
“Some of the women, the state they’ve been left in, they suffer terrible pain and some are getting addicted to painkillers that they’ve been prescribed.”
According to the solicitor, removal of the mesh is “fairly gruesome” as it is designed to become part of the walls of the person’s organs.
“It’s like chicken wire put in to hold up organs and the organs start coming through it.
“It’s like trying to remove chicken wire from the bladder or the bowel, all the really sensitive bits. You could end up with a colostomy bag for the rest of your life.”
Power said some of the women she has spoken to did not even know what kind of surgery they had or what kind of device they had put in.
‘Barrier to justice’
Liam Moloney also has a small number of clients affected by this issue, with one due before the courts over the next few months.
He stressed that any woman who is having this procedure is supposed to be told about all of the risks involved.They should be told that it can migrate - in one in a thousand cases, it can cause perforation of the uterus. It doesn’t matter how remote the risk is, they have to advise the patient of any risks before they consent. If they haven’t the patient could take an action against the implanting doctor.
Complications from surgery to repair prolapse of the uterus are listed on the HSE’s websiteand include:
· The mesh wearing away – further surgery may be required to remove and replace the mesh
· Damage to the surrounding organs, such as your bladder
· Infection
· Pain during sex
· Vaginal discharge
· Vaginal bleeding
· Experiencing more prolapse symptoms – which may require further surgery
· A blood clot forming in one of your veins (for example, in your leg).
“I’m surprised there hasn’t been more of these cases. I suspect there are quite a substantial number of cases in Ireland where people haven’t linked the problems with the device,” Moloney said.
He said it can be difficult to establish whether there is a defect with the device or whether it was inserted incorrectly by the surgeon without expert evidence. This is costly, according to Moloney, as it can only be sourced in the UK, “given the reluctance in Irish medical professionals to give evidence against one another”.
(TheJournal.ie contacted a number of Irish experts and clinicians in gynaecology for input into this article, but none responded to interview requests.)
Moloney said the lack of legal aid for people in these types of civil cases can also be a “significant barrier to justice”.
European review
In response to a query from TheJournal.ie, the Health Products Regulatory Authority (HPRA) said it does not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants as it does not have a direct role in licensing or certifying them.
Medical devices which have been appropriately CE marked and which meet all EU requirements can be freely placed on the European market. The authority did say it had identified “two unconfirmed reports of incidents” in respect of these devices.
“The HPRA is aware of reports of complications relating to the use of surgical meshes. At European level, the safety of surgical meshes used in urogynecological surgery was reviewed by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR),” it said in a statement.
A number of women affected by this issue made submissions to the committee, including one Dutch woman who said that she had several operations over a six-year period after the implant procedure.
“I still have severe pain every day and even special medication and operations for pain blocking do not make any difference. When I was 51 I went for the mesh, after the operation I felt like an invalid woman of almost 100 years [of age],” she said.
The committee’s report said there was a need for further improvement in the composition and design of synthetic meshes, in particular for female pelvic organ prolapse surgery.
It also recommended that non-invasive solutions should be considered before resorting to surgery and the amount of mesh should be limited where possible.
The HPRA said that in January last year, it sent the SCENIHR opinion and the related fact sheet to The Royal College of Surgeons in Ireland and The Royal College of Physicians in Ireland for onward distribution to their members.In 2009, 2011, and 2012, the HPRA also wrote to consultants in Ireland to inform them of notifications published by the Food and Drug Administration and the [UK's] Medicines and Healthcare Regulatory Authority in relation to this topic.
TheJournal.ie requested information from the HSE on the number of patients who have had a vaginal mesh implant procedure. A spokesperson said the data is currently being collated.
If you’ve been affected by this issue, we want to hear your story. Get in touch at michelle@thejournal.ie.
https://www.thejournal.ie/vaginal-mesh-3598969-Sep2017/
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Canada has a 'big blind spot' on medical device safety: study
Sep 18, 2017 | CTV News
A new study has found more than 7,200 medical devices were recalled in Canada between 2005 and 2014, ranging from hospital beds to major joint implants to hernia mesh.
“A lot of us think this is actually quite urgent and a big blind spot in health products that are used every day on millions of Canadians,” study co-author Dr. David Urbach, senior scientist at Women's College Hospital in Toronto, told CTV News.
Published in the “International Journal of Technology Assessment in Health Care,” researchers in Toronto, Montreal and Calgary reviewed medical device records filed with Health Canada.
They found more than 24,000 medical devices were approved for sale in Canada over 10 years.
As for the recalls, most issues were minor. But 300 recalls, or five per cent, were considered severe enough to cause “serious adverse health consequences” or death.
Shirley Houle is an example. The Port hope woman relies on an implantable pacemaker defibrillator to keep her heartbeat steady. Last October she received a warning letter about her device, made by St. Jude Medical -- it had a battery that could suddenly stop working.
The news, she said, was terrifying.
“I was afraid to go anywhere... afraid my heart my battery would go dead,” Houle said.
The anxiety left her unable to sleep, or even leave the house, she said.
It took six months before she got a new device.
Unlike medications, which undergo rigid pre-market testing, medical devices are often approved with little or no clinical testing in Canada.
Halifax resident Rod Desborough is another one of the thousands of Canadians whose medical device has been subject to a recall. His hip implant suddenly broke in two while he was gardening.
He had emergency surgery to replace the implant -- and repair the bone that shattered along with it.
“My leg is an inch-and-a-half shorter,” Desborough says. “It took me six months to learn to walk half-decent.”
The Wright Profemur Hip Implant was later recalled and taken off the market. Desborough is now part of a class action lawsuit.
Shirley houle is has also joined a class action against St. Jude Medical, the makers of her implanted pacemaker defibrillator.
But lawsuits aren't the best way of dealing with medical device recalls.
Halifax-based personal injury lawyer Raymond Wagner said more formal oversight of medical devices is needed in Canada.
Wagner, whose firm is handling several medical device cases, says makers are often under intense pressure from investors to quickly get their new products in the hands of doctors.
“We see that there is a rush to market,” he said. “There is a lot of money involved.”
Wagner said he has seen that push to sell turn into pain for a number of his clients.
“For instance, on a hip implant. They are designed to last 15 to 20 years. We were receiving failures from our clients of 18 months to two years, to three years after the product was implanted,” he said. “That is a huge impact on their well-being.”
Wagner feels the current practice of relying on the industry for self-regulation isn't working.
“We see there is strong pressure within the companies to say their failure rate is low … and to show that it’s not their product, just an incidental occurrence.”
“They don’t want to be reporting a whole lot of failure rates that may impact their economic relations that sit in the background, which really creates conflicts of interest that are a concern,” he added.
The researchers found that the onus falls primarily on the medical device industry to issue recalls when problems are identified, although Health Canada can impose a recall independently.
A recent study also found Canadian doctors are reluctant to report medical device adverse events.
“Physicians are actually expected to report problems with devices or other types of health products, but most physicians aren’t aware of that. Everyone seems to think it’s everyone else’s responsibility," said Dr. Urbach, who also co-authored this study.
Canada’s medical community still has a lot to learn about medical device recalls and their impact on patients and the health care system.
“We don’t yet understand what sort of devices are most often subject to these recalls, and what the reasons are for the recalls . . . and what the consequences are,” said Dr. Urbach. A formal tracking system for high risk medical devices may be required in order to spot problems like failing batters or fracturing implants quickly -- before more people are harmed.
“If we take the mindset that we can’t be assured 100 per cent of their safety, then we have to be constantly vigilant.”
Patients can themselves report adverse events or side effects from medical devices -- but most aren't aware of this.
Health Canada has a website for reporting medical device-related complaints.
Some doctors advise patients to ask about what medical devices are being implanted in their bodies. Doctors can supply the brand and model number.
While this information is in a patient’s medical file, it's advisable they also keep a copy in the event there are issues with a device.
With files from CTV’s medical affairs specialist Avis Favaro and Elizabeth St. Philip
http://www.ctvnews.ca/health/canada-has-a-big-blind-spot-on-medical-device-safety-study-1.3595575
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FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices
Sep 18, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 18, 2017 ~ The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market.
Here is another example of a newly announced pilot program that will help do just that.
Unlike drugs, high-risk medical devices, even some permanently implanted, make it market with relative ease.
Now the U.S. Food and Drug Administration (FDA) is launching a pilot program that aims to further streamline the premarket approval (PMA) process for some high-risk medical devices.
Published in the Federal Register, the FDA’s Center for Devices and Radiological Health (CDRH) will solicit nine companies to join a pilot program called Premarket Approval Application Critical to Quality (PMA CtQ). The program will run from September 29, 2017 until the end of December 2018.
The “FDA intends to work with each participating applicant to identify characteristics of its device and its manufacture that are critical to its quality, which may include specific device features or quality control practices. The identified CtQ characteristics and controls will help focus FDA’s post-approval inspection approach.”
Applicants would not be subject to pre-approval inspections of the medical devices, design and manufacture but instead focus on post-approval inspection.
There is no word in the Federal Register how an inspection could be conducted on an already implanted medical device or what the remedy would be if a design failure is determined post-market.
The agency says focusing on these activities would lead to fewer device failures, a decrease in device recalls, improved device innovation and efficiency and a streamlined inexpensive pathway to the market.
This is the latest example of FDA innovations that help device manufacturers get their devices to market faster under the “least burdensome” standard.
Upward of 95% of medical devices take the superhighway to the market through the FDA’s 510(k) clearance process (named for Section 510(k) of the Federal Food, Drug, and Cosmetic Act), after about 90 days, an exchange of paperwork, and a few thousand dollars.
That includes implantable medical device such as hernia mesh, transvaginal mesh, morcellator devices, hip implants, heart valve rings, and defibrillator leads, among other devices. See this Mesh News Desk story on medical devices that bypassed FDA scrutiny.
Patients and policymakers have long complained the clearance process does little to ensure medical devices are safe and effective.
Meanwhile the medical device industry complains that even the 510(k) is too burdensome and time-consuming and delays the launch of important new medical devices.
The 510 (K) process has long been scrutinized. In 2011 the Institute of Medicine called the clearance process “fatally flawed” and called for the outdated process to be abolished. ###
https://www.meshmedicaldevicenewsdesk.com/fda-pilot-program-helps-manufacturers-streamline-approval-medical-devices/
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Johnson and Johnson Must Pay $57M in Pelvic Mesh Case
Sep 18, 2017 | The Legal Reader (blog)
By Jay W. Belle Isle
Ella Ebaugh, a resident of Pennsylvania, knows about pain. She was diagnosed with stress urinary incontinence (SUI) in 2005. In 2007, Mrs. Ebaugh did as many women: she trusted that pelvic mesh implants would fix the problem. Also like many women, Mrs. Ebaugh discovered that the mesh devices – these made by Johnson & Johnson’s Ethicon division – caused more problems than they solved. Problems that ultimately lead Mrs. Ebaugh to sue J&J. Earlier this month, a jury in Philadelphia awarded Mrs. Ebaugh $57.1M.
According to the Mayo Clinic, “stress [urinary] incontinence happens when physical movement or activity — such as coughing, sneezing, running or heavy lifting — puts pressure (stress) on your bladder. Stress [urinary] incontinence is not related to psychological stress.”
Mrs. Ebaugh underwent two mesh implants to treat her SUI. One was Ethicon’s TVT-Secur and the other, Ethicon’s TVT. A few years after getting the implants, Mrs. Ebaugh began having “excruciating pain” in her pelvic region. The mesh had eroded into her urethra.
She underwent three separate surgeries to have the mesh removed. During her recovery from one of those surgeries, Mrs. Ebaugh saw a television commercial dealing with eroding pelvic mesh implants. After doing some research, she decided to file suit. Her lawyer, Kila Baldwin of Kline & Specter, said that thousands of women have undergone pelvic mesh implantation.
The trial, which took one month, resulted in J&J being hit with the $57M verdict. According to Ms. Baldwin, $7M of that amount is compensatory damages due to “negligent design and strict product liability design defect.” The other $50M is in punitive damages, meant to send J&J/Ethicon a deterrent message.
In an interview with the York Daily Record, Mrs. Ebaugh said of the verdict, “I never thought this day would come.” However, J&J, as expected, said it intends to appeal the verdict, which means Mrs. Ebaugh will not receive any money anytime soon.
J&J/Ethicon spokesperson Kristen Wallace told Philly.com, “We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems.”
However, some evidence admitted during the trial showed that J&J “intentionally manipulated the literature regarding problems with the products and withheld information about complications and injures from doctors.” Ms. Baldwin also highlighted internal company emails that helped the jury find in favor of Mrs. Ebaugh.
For her part, Mrs. Ebaugh’s life will never be the same. Even a $57M verdict won’t end the pain she experiences each day, nor will it eliminate the huge impact mesh has had on her life.
“A lot of days, I can’t get out of bed. I struggle every day. I will struggle with that pain every day for the rest of my life,” she said. “Yes, I will wear diapers the rest of my life. Yes, I can’t be intimate with my husband. Yes, I’m depressed. These are things I will carry with me for the rest of my life.”
Mrs. Ebaugh, a mother of four, has the full support of her husband and children. Rather than focus on the challenges of her situation, she is trying to be positive and create a new “normal” version of life. Things such as family gatherings and her 16-year-old son’s baseball and football games are her focus. Even these things are not without challenge, though.
As she said, she is “chained to a bathroom,” and must make sure she sits near one at her son’s games. Mrs. Ebaugh needs a special chair for visits to her mother and must also carry a diaper bag.
Though her husband, Marvin, and her four kids are very supportive, Mrs. Ebaugh chose to keep them away from the courtroom during the trial. She simply didn’t want them exposed to what J&J’s defense attorneys had to say.
After the verdict, Mrs. Ebaugh said, “I’m just glad Johnson & Johnson is finally getting their hand smacked when it should be. They’re doing things seriously hurting and harming women everywhere.”
http://www.legalreader.com/johnson-and-johnson-must-pay-57m-pelvic-mesh/
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