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Ethicon Media Monitoring 7/10/2017
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Johnson & Johnson tried to prevent report about pelvic mesh devices, court hears
Jul 10, 2017 | The Guardian
By Christopher Knaus
The pharmaceutical giant Johnson & Johnson tried to stop French health authorities publishing a report about the dangers of its untested pelvic mesh devices, two years after they began using them on Australian women, a court has heard. -
'I could never have sex again': How a vaginal mesh implant left a Sydney woman in horrific pain and her husband too scared to touch her - as hundreds launch class action
Jul 10, 2017 | The Daily Mail
By Kate Darvall
When Louise King underwent surgery to fix a prolapsed vagina in 2006, she had no idea the vaginal mesh implant she received would change her life forever. -
The Disorder Affecting 1 in 3 Women You Don't Know Much About
Jul 10, 2017 | Mom.me
By Irina Gonzalez
It's not always easy to talk about the changes that happen to your body after giving birth but, for one woman, those changes were particularly horrific. Although the home birth of her daughter went smoothly, Kimberly Johnson experienced a nightmare afterwards. -
It may be embarrassing to talk about, but there’s help for incontinence
Jul 10, 2017 | Idaho Statesman
By Lisa Parrillo
Incontinence. It’s not something we talk about at brunch or during halftime at a Boise State game, but it is something that affects many lives each and every day. Thankfully, there are things urologists can do to help. -
Florida Woman to Have Physiomesh Surgically Removed
Jul 7, 2017 | The Legal Examiner
By Roopal Luhana
On May 16, 2017, a Florida woman filed an Ethicon Physiomesh lawsuit in the Northern District of Florida. She claims that she suffered serious injuries after having Physiomesh implanted. -
Patients, not practitioners, need protection
Jul 10, 2017 | Newcastle Herald
It might seem to be self-evident that patient care is the point at which health delivery revolves, but the growing scandal over how thousands of Australian women were implanted with pelvic mesh devices for more than a decade has shown how far we have strayed from this ideal.
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Johnson & Johnson tried to prevent report about pelvic mesh devices, court hears
Jul 10, 2017 | The Guardian
By Christopher Knaus
Hundreds of Australian women launch class action Johnson & Johnson companies alleging meshes caused chronic and debilitating pain
The pharmaceutical giant Johnson & Johnson tried to stop French health authorities publishing a report about the dangers of its untested pelvic mesh devices, two years after they began using them on Australian women, a court has heard.
Hundreds of Australian women have launched a class action against three Johnson & Johnson companies alleging the meshes – used to treat two common childbirth complications – have caused them chronic and debilitating pain, ruined their sex lives and, in some cases, destroyed their lives.
Thousands of patients in the UK, Canada and the United States have launched similar cases.
On Wednesday, the federal court in Sydney heard Australian women were effectively used as “guinea pigs” by the Johnson & Johnson group.Vaginal mesh risks downplayed by Johnson & Johnson, court told
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Barrister Duncan Graham SC told the court the devices were not properly tested before they were approved by the Therapeutic Goods Administration and placed on the Australian market in 2005.
Johnson & Johnson instead conducted an aggressive marketing campaign aimed at convincing surgeons the devices were inexpensive, simple to implant, and therefore a lucrative alternative to other treatment options. No randomised controlled trials were conducted, the court heard, and the scant testing that was available was insufficient or too short-term.
Had such trials been conducted, Graham said, they would have found the devices posed an unacceptable risk to women.
“It was sell first, test later,” Graham said. “The women who had them implanted were part of an experiment, they were guinea pigs,” he said.
The court has been shown internal documents from one of the Johnson & Johnson companies, Ethicon, suggesting it knew it lacked the proper trials.
In 2007, the French health authority, Haute Autorité de Santé, was preparing to release a report on the mesh devices. The report found a proper randomised controlled trial was needed before the devices could be approved. It concluded they should be used only in clinical research until such a trial was complete. At that stage, the devices had been on the Australian market for two years.
The looming French report prompted concern within Ethicon. Meeting minutes described in court show the company feared the report “could have a major impact on our business if made public”.
It said work was needed to “stop the publication of the report”.
“So there is no randomised clinical trial, the [French] commission wants one and essentially until it gets one, Prolift, which has already been on the market in Australia for two years, is considered only suitable for clinical research,” Graham told the court.The stories you need to read, in one handy email
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The court also heard evidence about the origins of a journal article supportive of the safety and efficacy of the devices, which was published in the New England Journal of Medicine in 2011.
Graham said the journal had been forced into an “embarrassing” correction two years later, after it emerged the study had failed to properly disclose the involvement of Ethicon in the study. Ethicon had paid the authors consultant fees, and reviewed the original study protocol and a presubmission draft of the manuscript.
The presubmission draft differed in several respects from the published article, the court heard. The final article also omitted important information about Ethicon’s involvement in the study, the court heard.
Part of the device’s appeal to surgeons was the apparent ease with which it could be inserted. Johnson & Johnson marketed the mesh’s implantation as a standardised technique. That claim, Graham alleged, was a “pipe dream, and a dangerous one at that”.
He said there was variability in the technique, and the surgery was complex, beyond the skills of lesser-trained or inexperienced surgeons.
A study published in the Lancet in December found that women who were given mesh implants were roughly three times more likely to suffer complications and twice as likely to need follow-up surgery compared with women who had the traditional version of the surgery, where stitches are used to provide support for the organs.
The case continues before Justice Anna Katzmann.
https://www.theguardian.com/australia-news/2017/jul/10/johnson-johnson-tried-to-prevent-report-about-pelvic-mesh-devices-court-hears
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Jul 10, 2017 | The Daily Mail
By Kate Darvall
· Louise King is one of hundreds to sign onto a class action over mesh implant
· Ms King underwent surgery to fix a prolapsed vagina in 2006
· 'The only option' was for her to get a vaginal mesh implant involved
· But implant left her suffering debilitating pain and unable to make love
· She's one of 700 women to sign on to a class action against Johnson & Johnson
When Louise King underwent surgery to fix a prolapsed vagina in 2006, she had no idea the vaginal mesh implant she received would change her life forever.
Ms King was unable to have sex with her husband again and suffered debilitating chronic pain.
She is one of 700 women who launched a class action against pharmaceutical giant Johnson & Johnson this year, because claim to have suffered life altering complications from the vaginal mesh implant.
The class action lawsuit, which was launched in the Federal Court this week, highlighted the incredible struggles hundreds of Australian women have battled due to the implant.
Ms King said she was given 'no choice' but to have the mesh implant when she suffered the prolapse 11-years ago.
'When I had a prolapse, my bowel and everything prolapsed into my vagina,' she told Daily Mail Australia.
'There was no choice, I was told this was the only option.'
Ms King said she noticed something was very wrong six-weeks after her operation.
'For a long time, while I was healing, my husband and I didn't try to make love, but when we did it was agony,' she said.
'Before he even entered me I was screaming, it was agonising.
'We tried a few times but he became really scared to touch me. He got to a point where he couldn't touch me.
'I could never have sex again.'
Ms King said she was given no support when she went back to see her specialist at the hospital.
'He told me there was nothing wrong,' she said.
'He said "I can examine you with two fingers so you're big enough (to have sex)".'
Louise said her inability to make love to her husband damaged their marriage.
'When you lose that closeness in the bedroom, you also lose it out of the bedroom,' she said.
'He used to walk into the kitchen and just hug me, we were soulmates. But eventually we stopped holding hands walking down the street.'
Ms King said her husband eventually became impotent, was diagnosed with prostate and lung cancer in 2012 and died in 2014.
Shine Lawyers, who is defending the group of women, claims the mesh erodes into tissue and organs in the body, causing incontinence, infection and chronic pain.
Ms King said her inability to have sex was just the beginning of the suffering she would endure from the mesh implant.
'I suffer with chronic pain,' she said.
'Just yesterday I was at hospital having injections all over my body to try and ease the pain,' she said.
Ms King said the chronic pain started four years after the operation and worsened each year.
She said the pain forced her to give up her 'dream job'.
'I wasn't well enough, I couldn't climb stairs, I couldn't drive, I couldn't get out of bed some days,' she said.
'It totally changed my life.
'I've had so much bad health since that operation. There are days that I can't get out of bed and there are days that I try to do things and I just can't.
'My grandchildren don't understand the pain either – I constantly can't do things that I want to do with them.'
Ms King said it was difficult to pinpoint the pain caused by the mesh, but it reached the deepest parts of her body.
'You don't feel anything in the vaginal area, but I know I can't use any of the deep muscles in my stomach,' she said.
The grandmother also said she felt the pain down her limbs.
Ms King suffered in silence for years, not knowing there were hundreds of women also suffering.
She said her life changed when she read about a woman in the paper who also lived with the debilitating pain caused by the mesh implant.
'When I called them they told me there were hundreds like me,' she said.
'It was so good knowing that I wasn't going crazy.'
Ms King said she did not expect the class action against Johnson & Johnson to help her financially, she just wanted it to be a warning to other women.
She wants her story told to prevent others from enduring the same life-altering pain.
Ms King said she felt only anger towards the company who sold her the vaginal mesh implant, and could not believe the product was still being marketed to women.
'I'm angry, really angry,' she said.
'And they're still selling it. It's an arrogance, they just don't care.'
The Australian class action comes after more than 100,000 women launched legal action against the company in the US, the UK and Canada.
Shine Lawyers opened its case in the Federal Court in Sydney this week, with hearings expected to run for about six months.
The case continues.
http://www.dailymail.co.uk/news/article-4670162/Grandma-tells-vaginal-mesh-implant-pain-amid-lawsuit.html
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The Disorder Affecting 1 in 3 Women You Don't Know Much About
Jul 10, 2017 | Mom.me
By Irina Gonzalez
The Disorder Affecting 1 in 3 Women You Don't Know Much About
It's not always easy to talk about the changes that happen to your body after giving birth but, for one woman, those changes were particularly horrific. Although the home birth of her daughter went smoothly, Kimberly Johnson experienced a nightmare afterwards.
A pelvic tear that didn't hear properly and a uterine prolapse (where the top of her birth canal dropped into her vagina) took nine months to diagnose. It was six years before she felt completely healed of a disorder that research shows happens to about one in three American women, according to Today.
It's called pelvic floor disorder and, although it's not new a new condition, experts say there's more talk about it, thanks to celebrities such as "Girls" star Zosia Mamet speaking openly about her experience. With so many women suffering from this disorder during their lifetime, it's important to know its symptoms such as urinary and fecal incontinence, constipation, pelvic organ prolapse and pain during intercourse.
The important thing to know about this disorder is that it isn't normal and women should not have to suffer. Although Johnson's case was particularly gruesome, she reports being "so relieved" to have finally found help but was still shocked to "encounter this black hole in women's health." Women need to be well-informed about this potential medical condition.
"These are sensitive topics that can be difficult to broach with a doctor," Dr. Barbara Levy, vice president of Health Policy for the American Congress of Obstetricians and Gynecologists, told Today. "I want women to know that there is help available for them if they want it."
The first thing to know is that the pelvic floor is not really a floor, but rather a three-dimensional bowl-like network of muscles and connective tissue that extends between the hip bones, the pubic bone and the tail bone. Second, Kegel exercises may not be your answer since, although they help women with incontinence, they can actually make things worse.
If you have signs of pelvic floor disorder, you should see your doctor or OB-GYN. The good news is that treatment options can range from non-invasive to surgical. These include pelvic floor physical therapy, the use of a tampon-like insert for stress incontinence or a diaphragm-like pessary which supports the pelvic organs and holds them up and in place. Botox injections in the bladder and surgical options can also help with many types of dysfunction.
What you shouldn't try, however, is a jade egg (no matter how many celebs say they do it). An iPhone-synced device such as the $199 Elvie, another kind of pelvic floor trainer, might be a better option because it could help you stick to a routine, but you should really see a doctor or physical therapist that specializes in treating pelvic floor issues rather than self-diagnosing and treating.
"Walking around with a jade egg in your vagina would be like trying to make your upper body stronger by carrying a 5-pound dumbbell around," Dr. Kimberly Kenton, director of the Women's Integrated Pelvic Health Program at Northwestern Medicine, told Today. "It doesn’t work that way."
However, specialists are hopeful that, with more awareness of the pelvic floor and problems associated with this disorder, more women can get treatment sooner to improve their quality of life.
https://mom.me/news/87882-pelvic-floor-disorders/
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It may be embarrassing to talk about, but there’s help for incontinence
Jul 10, 2017 | Idaho Statesman
By Lisa Parrillo
Incontinence. It’s not something we talk about at brunch or during halftime at a Boise State game, but it is something that affects many lives each and every day. Thankfully, there are things urologists can do to help.
Up to 40 percent of women and 35 percent of men experience some degree of incontinence, the accidental leakage of urine. There are many different types of incontinence. Stress urinary incontinence is leakage that happens when laughing, exercising, straining, sneezing, coughing or the like. This is more common in women than men, but it also can happen to men who have had pelvic or urological surgeries. Urgency urinary incontinence is leakage when one has the need to urinate and just can’t hold it. Mixed urinary incontinence is a combination of the two. These are the most common types of incontinence. More rarely, people will experience leakage with a change in position or while sleeping, or they will sometimes even leak constantly.
But why does incontinence happen? It depends on the person and their health history. Some risk factors are aging, pregnancy, race, obesity, smoking, diet, medical conditions such as diabetes and certain surgical procedures or radiation treatment. Many men who have undergone treatment for prostate disease will develop some leakage.
The good news is that there is help. Urologists can’t help you get your 20-year-old bladder back, but there are many treatments that can significantly reduce the leakage and improve your quality of life.
The first step is to see a urologist. He or she can help you figure out what type of incontinence you have and build a treatment plan that is specific to you.
Conservative treatments include behavioral modifications, such as changes to diet and fluid intake, exercises to increase pelvic-floor strength and medications. For men and women with stress urinary incontinence, slings can be placed beneath the urethra (the tube where urine flows from the bladder). These slings help reposition the urethra to where it was before childbirth or a prostatectomy. This helps prevent leakage during physical exertion. In women, these slings can be made of mesh or from tissue harvested from the abdomen or thigh, or from cadavers or from animals. Men also have the option of an artificial urinary sphincter, an inflatable cuff that is placed around the urethra to prevent leakage.
Urgency urinary incontinence often results from the bladder muscle contracting when you don’t want it to. There are medications available that help many people.
If the medications don’t work, one option is stimulation of the nerves that control the bladder to help prevent the muscle from squeezing. This can be achieved with either an outpatient treatment in which the nerve is stimulated with an acupuncture-like needle placed at the ankle or with a surgical procedure in which a small stimulator and wire are implanted in the lower back near the sacral nerves.
Another option is a Botox injection in the bladder. In the same way that Botox injected in the forehead relaxes the muscles of the face, an injection in the bladder relaxes the bladder muscle and prevents it from squeezing inappropriately.
These therapies can make a difference. If you’re having issues, seek out a urologist to discuss your options. We can help.
http://www.idahostatesman.com/living/health-fitness/article160224969.html
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Florida Woman to Have Physiomesh Surgically Removed
Jul 7, 2017 | The Legal Examiner
By Roopal Luhana
⦁ Roopal Luhan is an attorney with Chaffin Luhana LLP
On May 16, 2017, a Florida woman filed an Ethicon Physiomesh lawsuit in the Northern District of Florida. She claims that she suffered serious injuries after having Physiomesh implanted.
The woman blames manufacturer Ethicon and parent company Johnson & Johnson (J&J) for her injuries and seeks damages in excess of $75,000.Plaintiff Has Allegedly Defective Mesh Surgically Removed
According to her complaint, the plaintiff had a 15 x 20 cm Physiomesh composite mesh implanted on November 21, 2011. She underwent the procedure to repair a ventral hernia, which is a bulge of abdominal tissue that protrudes through a weak area of the abdomen.
Most ventral hernias take a long time to develop, as the abdominal muscles gradually weaken with age or with childbirth. They may occur after pregnancy, or after another abdominal surgery. Mild cases can be treated without surgery, but more severe cases will not heal on their own and require repair.
The plaintiff alleges that the manufacturers represented their product was safe and effective, and that neither she nor her doctor had any reason to believe it wouldn’t work as expected. But the product, in fact, caused her serious injury and she had to undergo a revision surgery due to these complications. She also required another surgery to fix the hernia that the Physiomesh was initially implanted to treat.
The plaintiff says she suffered a severe adverse reaction to the mesh, and that she will continue to suffer physical injury, pain, and mental anguish, along with permanent and severe scarring and disfigurement.Plaintiff Claims Design of Physiomesh is Defective
In May 2016, the manufacturers issued an urgent field safety notice alerting hospital and medical providers to a voluntary product recall. As the basis for the recall, they cited data from two international device registries that showed recurrence and reoperation rates were higher with Physiomesh than with other comparable meshes.
The company advised medical personnel worldwide to immediately stop using their Physiomesh products and return them to Ethicon for reimbursement.
The plaintiff notes that the design of the Physiomesh is the problem. It has five distinct layers, with the outer two made of a “Monocryl” film covering two underlying layers of PDS film, which in turn coat the core polypropylene mesh. “This design is not in use in any other hernia repair product sold in the United States,” the plaintiff states in her complaint.
The defendants promoted this design as one that would help prevent or minimize adhesion and inflammation, and encourage incorporation of the mesh into the body. Instead, it seemed to prevent incorporation, and to contribute to an intense inflammatory reaction. Since the outer “coating” layers were impermeable, they prevented fluid to escape, which can lead to the formation of seromas—pockets of fluid buildup—which in turn could increase the risk of infection and abscess formation.
This multi-layer design, the plaintiff asserts, also provided a breeding ground for bacteria, creating a greater risk of infection, delaying wound healing, and increasing the risk that the body would reject the mesh. She adds that when the multi-layer coating of the mesh degrades, the mesh itself can adhere to organs and cause more damage. She brings counts of defective design, failure to warn, and negligence.
This lawsuit is one of many filed by patients injured by Physiomesh. On June 2, 2017, the U.S. Judicial Panel on Multidistrict Litigation granted a motion to consolidate all federally-filed cases for pretrial proceedings. Those cases were transferred to the Northern District of Georgia and will be overseen by the Honorable Richard Story.
http://newyork.legalexaminer.com/medical-devices-implants/florida-woman-to-have-physiomesh-surgically-removed/
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Patients, not practitioners, need protection
Jul 10, 2017 | Newcastle Herald
PATIENTS need to be put back to the centre of the medical system in Australia.
It might seem to be self-evident that patient care is the point at which health delivery revolves, but the growing scandal over how thousands of Australian women were implanted with pelvic mesh devices for more than a decade has shown how far we have strayed from this ideal.
The history of how regulators have responded to women’s complaints about former University of Newcastle associate professor Richard Reid – as documented in the Newcastle Herald for nearly three years – provides evidence of the gap between public expectations of patient safety and how regulators view public protection.
The most recent example of that gap occurs in how the NSW Medical Council monitored Dr Reid from 2011 following complaints by women linked to pelvic mesh surgery.
Conditions placed over his practice after those complaints included one relating to how he obtained valid informed consent from women for the surgery he carried out. It also included a condition requiring Dr Reid to submit a surgical log of each procedure he carried out to the Medical Council every three months.
By 2011 the Medical Council was already well aware of Dr Reid’s “extensive complaint history” in Australia and America where he had already been suspended after serious injuries to women patients. But it was not put on notice, by that history, of any need to pay particular attention to documents supplied by Dr Reid to meet monitoring conditions.
It relied on Dr Reid to self-monitor, which is why its response to Herald questions about an apparently false referral in one of the surgical logs is of concern.
The Medical Council’s argument that because its condition only required monitoring of the “type” of surgery Dr Reid performed, and not the veracity of any other detail in the log supplied by him, falls far short of what a reasonable person would expect of a regulator under the circumstances.
Another serious question that must be asked, as a Senate inquiry prepares to hear evidence in public about the scandal of pelvic mesh in Australia, is how patients are largely unaware of a doctor’s history when they walk into a surgery door – and how little our current regulatory system assists people to find out for themselves.
http://www.theherald.com.au/story/4778972/patients-not-practitioners-need-protection/
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