Preview Newsletter
Ethicon Media Monitoring 5/26/2017
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Women Claim This Surgery Has Cost Them Their Happiness, Their Sex Lives, And Hundreds Of Thousands Of Dollars
May 25, 2017 | BuzzFeed News
By Gina Rushton
Caz Chisholm is one of the hundreds of women at the centre of what has been dubbed the "greatest medical scandal" in Australia's history and is the subject of an ongoing Senate inquiry, as well as multiple court battles between patients and pharmaceutical companies. -
Thousands of women left in agony after ‘gold standard’ surgery
May 25, 2017 | New York Post
By Shaunna Murphy
When 33-year-old Melynda Harrison Fitt visited a urogynecologist (a gynecologist who specializes in pelvic floor issues) about some pressure in her lower pelvis back in 2006, the personal trainer and mother of three had no clue the so-called “gold standard” solution pushed by her doctors would lead to a lifetime of agony. -
Mesh Implant Nightmare
May 25, 2017 | Ballarat Courier
By Melanie Whelan
BALLARAT mother Fran Harris wants to describe the destruction a mesh implant, intended to fix her prolapse, has inflicted on her life from the inside-out. -
Morcellator Activist, Victim Amy Reed Dies at 44
May 25, 2017 | Mesh Medical Device Newsdesk
Amy Reed, the Philadelphia physician who put a public, tragic face on the outcome of unregulated medical devices has died of a rare form of uterine cancer. -
J&J’ Deceptive Practices Brings $33 Mil Fine
May 25, 2017 | Mesh Medical Device Newsdesk
For years, the healthcare giant has faced scrutiny over the cleanliness of its plants that produce its over-the-counter products. -
SUI, POP Reoperation Low at 5 Years
May 25, 2017 | Renal and Urology News
For women undergoing surgery for stress urinary incontinence (SUI) and pelvic organ prolapse (POP), the risk of repeat procedures is less than 10%, with increased risks for older women and initial POP surgery, according to a study published in the June issue of Obstetrics & Gynecology. -
Report: Women More Affected by Dangerous Drugs and Devices
May 25, 2017 | DrugWatch
By Elaine Silvestrini
.... Transvaginal mesh, is an implant used to treat pelvic organ prolapse and stress urinary incontinence. But this device can fail, causing pain, bleeding and infection, and can be impossible to completely remove.
Online Sources
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May 25, 2017 | BuzzFeed News
By Gina Rushton
Caz Chisholm is one of the hundreds of women at the centre of what has been dubbed the "greatest medical scandal" in Australia's history and is the subject of an ongoing Senate inquiry, as well as multiple court battles between patients and pharmaceutical companies.
In January 2014 Chisholm was told by her gynaecologist that urogynaecological surgical mesh was the best treatment option for her urinary incontinence (poor bladder control).
"I just wanted to be able to run around with my son and kick a ball," the Perth mother told BuzzFeed News.
Urogynaecological meshes, sometimes known as transvaginal meshes, are used to treat two main conditions affecting women.
One is urinary incontinence, and the other pelvic organ prolapse – when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth. In the latter case the mesh is implanted under the urethra (the tube that empties urine from the bladder).
The meshes come in different shapes and sizes such as 'sling', 'hammock', 'tape' and 'ribbon' and can be non-absorbable which means the mesh will remain in the body indefinitely. This means it is considered a permanent implant.
"[The doctor] didn't really explain many of the side effects or possible complications and I just had such immense trust in her," Chisholm said.
The plastic net-like implant was put through her vagina to support the urethra.
She woke up from the surgery with an "excruciating pain" in her legs which spread throughout her pelvis and pubic area.
"Even six weeks afterwards I was scared of going for a swim because I didn't think I could recover if I fell over.
"I felt like I had crawling ants in my pelvic region and I was told it was a nerve thing."
Her vulva turned white with the skin disease lichen sclerosus which can be itchy, painful and cause permanent scarring.
"I was bleeding from scratching it... I was sent to a dermatologist who just gave me a steroid cream."
Steroid cream is the approved treatment method for that condition.
Nine months after the operation Chisholm was still sleeping with a pillow between her legs and regularly changing the position in which she slept to ease the pain.
"I [had also] lost all feeling in my clitoris."
"My anxiety was through the roof at this point, so I went online and found women with issues similar to mine, and I realised the only way I could recover from this was to get it fully removed."
She set up Australians Pelvic Mesh Support Group on Facebook in November 2014 and it has since connected more than 800 women around Australia, many of whom meet up regularly in person to support each other.
“A lot of us have been told that we are imagining it because women are always treated like hypochondriacs," Chisholm said.
She could not find a surgeon in Australia who would remove the entire implant but she, and dozens of other Australian women, found their only option for removal in the United States.
Mesh implant patients travel from around the world to St. Louis, Missouri, to see obstetrician-gynecologist Dionysios Veronikis.
Veronikis said he has performed more than 1,000 mesh removal surgeries since 1994, and seen a rapid increase in patients over the past five years.
“A society is sometimes judged by the way it treats its women and children... and I think this was a dark chapter,” Veronikis told St Louis Post-Dispatch.
"These women’s lives are altered permanently.”
Chisholm spent A$35,000 on the trip and operation.
"I am a single mum and I was working part-time... I had to get a personal loan and borrow money off my parents and I'm still paying that off now.
"I was there for about three-and-a-half weeks and when I got back to Australia it took me about six months before I could actually function normally, and I have never really got back to where I used to be.
"I can't walk for longer than 45 minutes."
Chisholm was worried about permanent nerve damage, however the feeling has returned to her clitoris.
"The thing with these devices is quite often women are injured and have painful sex," she said. "There are some women in the group whose husbands have left them [because of the impact the mesh had on their sex lives]."
Unfortunately for Chisholm the original complication, urinary incontinence, had morphed into urge incontinence – a sudden and strong need to urinate.
"Sometimes I actually wet the bed now."
Other potential treatment options for urinary incontinence include behavioural therapy, medications, botox injections and surgery.Urogynaecological surgical meshes were developed to treat urinary incontinence in women. They have since been used to treat pelvic organ prolapse – a complication after childbirth – which was the case for South Australian woman Kim Blieschke.
She had a polyproplene mesh implant inserted into her vaginal wall to treat a pelvic organ prolapse.
From the moment she woke up from her transvaginal mesh implant surgery in 2006, her life has been defined by debilitating pain.
"Right from the get go I was in a world of pain with great big bruises around my groin and buttocks," the paramedic and mother-of-four told BuzzFeed News.
The procedure was described by her doctor as minor, temporary and uncomplicated, yet for the next decade Blieschke's life would include disheartening doctors appointments, repeated surgeries and a desperate search for a solution to her discomfort.
"[The implant] had been suggested over a different operation which would have required six months off work, and I have a daughter with special needs, she is Down syndrome, and I didn't want to go down that path," she said.
"Not once was I told it was permanent. I was shown a little piece of gauze-like curtain material... the problem is when you implant it into bodies it goes as hard as cement within weeks."
Blieschke, who was 38, took three months off work as she was bedridden with pain.
"The next month I kept bleeding and my partner could feel something hard and sharp inside me when we were intimate, so I went to the doctor and I was told that there was a fistula [cavity] in my vaginal wall where a bit of the mesh had eroded through, so the doctor trimmed it there and then, which was excruciating."
The mesh eroded through Blieschke's vaginal wall eight more times.
By this stage, she could smell necrotic flesh.
"It smelled putrid and I have since learned that I was having a foreign body reaction, so my body was trying to get rid of the mesh like a splinter that you reject."
Blieschke said she was told by her surgeon there was no one in Australia who could remove the entire device, and that he attempted to partially remove the implant.
"He said it wouldn't happen again, but 12 months later it eroded through, and so in 2013 I had another two surgeries, and by this stage I had been under nine general anaesthetics, and I just had no idea what to do."
Six years after the surgery, Blieschke was still working as a paramedic where she had to stop taking painkillers during her shift to be able to drive, causing the constant pain in her joints to flare.
"By that stage, the arms of the implant were embedded in my bowel and rectum and wrapped around my urethra, so the surgeon said if they removed it I would have an urostomy and colostomy bag."
Blieschke ended up flying to St. Louis to see Dr Veronikis.
In January last year, Veronikis spent seven hours in surgery to remove Blieschke's implant, bar two small pieces that had migrated into her groin and attached to blood vessels.
She paid A$50,000 upfront and took six months off work.
"I was only in the hospital for 24 hours, because American hospitals are so expensive, and then I was in a hotel for nine days with a catheter.
"[Veronikis] told me my entire pelvis was scar tissue."
Blieschke has seen improvements since the removal but said some days she still has to stay in bed.
"Now I'm just campaigning for women to have informed consent, because surgeons are still putting mesh in them, and it breaks my heart every time a new woman joins the [Facebook] group," she said.
She told BuzzFeed News she wasn't joining a class action with law firm Shine against the maker of her implant, Johnson & Johnson, because patients had to have acted within a seven year period.Supplied
A Senate inquiry launched in February will hear from women affected by the implants and doctors, and will also examine the Therapeutic Goods Administration's (TGA) "knowledge of women suffering from health problems after having transvaginal mesh implants".
Submissions to the inquiry close at the end of the month and the committee will report in November this year.
Blieschke was one of the women who travelled to Canberra to appeal to senator Derryn Hinch, who has subsequently backed victims' calls for the inquiry into mesh products. Hinch described it as “one of the greatest medical scandals and abuses of mothers in Australia's history".
“Once again the drug companies and the so-called watchdogs like the Therapeutic Goods Administration are letting victims down,” Hinch said in a speech to federal parliament in November.
"[Patients were] treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA."The TGA approved the first of more than 40 different mesh devices for transvaginal surgery to treat prolapse in 2005.
Last year The Newcastle Herald reported that the TGA had been informed in 2003 that “no peer-reviewed, good quality evidence [was] available to determine the safety and efficacy” of incontinence mesh devices.
“The safety and efficacy of the procedure cannot be determined at the present time due to an incomplete and poor quality evidence base,” a 2001 report from the Australian Safety and Efficacy Register of New Interventional Procedures said.
In the four years to June 2016, the administration said it had received 99 adverse event reports involving the meshes. The most frequently reported side effects were pain and erosion, but others included punctures or lacerations of vessels, nerve structures and organs.
It was not until August 2014 that the TGA announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products” and moved to deregister devices that could not provide clinical proof of safety and efficacy.
By 2015, 72 of the 100 mesh products on the Australian market had been delisted.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has warned against the polypropylene mesh’s use for pelvic prolapse due to insufficient testing and concerns over complications, but has stated it is safe to treat continence conditions.Professor Thierry Vancaillie, who runs the Women's Health and Research Institute of Australia in Sydney, and is also a gynaecology professor at the University of NSW, said his clinic had been "inundated" with implant patients seeking advice to manage their pain.Mark Baker
"I currently see three or four [mesh implant patients] a week and my colleagues see a few too," Vancaillie told BuzzFeed News.
"It has been quite sad because a lot of these patients have been fobbed off by doctors who tell them it will get better and it is not getting better.
"These are patients with pain in the region and pain with every function of the perineum, so anything to do with the bladder, the bowel and intercourse."
Vancaillie last month flew to Veronikis' surgery in the US to learn how to remove the implants.
"I learned his technique and it was quite amazing, so I asked him if we could collaborate for patients in Australia," he said.
"He is essentially applying well established vaginal surgery principles to this particular type of surgery, and he has developed his own unique equipment to do so."
Vancaillie is returning to St. Louis in June with two fellow surgeons and a nurse from Prince of Wales hospital to "get all the equipment" and fine tune their skills so they can return to Australia and service patients here.
"The tendency in Australia is to take pieces of the mesh out, rather than the entire thing, which is unfortunate," he said.One woman who is hoping to undergo surgery as part of the initiative is West Australian Sue Turner.
"I have had two procedures for the two tissue anchors [part of the mesh] which have migrated through my body, one of which was in my bladder wall and one that had moved into my rectal wall," Turner told BuzzFeed News.
In 2007, her gynaecologist of four decades recommended a "tissue fixation system" mesh device. Since its insertion, she said she is $100,000 out of pocket as a result of treatment costs and lost income. She has learnt to live with constant pain and given up on romance.
"I am a single mum and I don't have any relationships because I can no longer have sex," Turner said. "I do everything on my own. I am limited going long distances travelling anymore. I can't walk around for more than half an hour maximum."
For years she was told by doctors her health problems were not linked to the mesh.
"I have pelvic pain, rectal pain, chronic fatigue, clinical depression, joint pain generally all over, skin rashes," Turner said. "I have to wee standing up like a man to empty my bladder."
She can't have an internal vaginal exam without going under a general anaesthetic because it is so painful.
"I pretty much cry myself to sleep every night."
The Facebook group has been validating for Turner.
"I realised I wasn't imagining all of this, and talking to other women reminds you that you're not going mad," she said.
"We meet up, but it is so hard not to get emotional."
Turner told BuzzFeed News she had received legal advice that it had been "too long" since her implant was inserted to pursue legal action.A class action representing 450 women against Johnson & Johnson subsidiary Ethicon will start on July 4 this year, focusing on nine different implants used to treat pelvic organ prolapse and urinary incontinence.
It is claimed the implants were not safe or fit for their purpose and caused a range of complications including organ perforation, pain, recurrent prolapse, recurrent stress urinary incontinence and vaginal scarring.
None of the women interviewed for this article are involved with that legal action.
Ethicon has faced legal action over its mesh products in Canada (where there is an ongoing case over its hernia mesh implants) and England (where 800 women are currently taking legal action aginst both the National Health Service and Ethicon).
"Our priority is and always has been patient safety, and pelvic mesh is backed by years of medical research," an Australian spokesperson for Johnson & Johnson told BuzzFeed News.
The company "empathised" with patients suffering from these conditions, she said, and their products had "helped millions of women suffering from these conditions".
"This is a complex court case. We are confident the evidence will show that Ethicon acted responsibly and appropriately."
In January 2016, Johnson & Johnson offered a settlement of US$120 million to more than 2,000 litigants in the United States.
Last month, a Philadelphia jury awarded $20 million to a woman who claimed she was in constant pain because of her Ethicon transvaginal mesh. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.
"Ethicon is vigorously defending litigation concerning the use of our pelvic mesh products," a Johnson & Johnson spokesperson said this month. "We believe the evidence shows the devices are safe."
In Scotland, around 420 women are involved in civil litigation against a different manufacturer of mesh products, Endo.
Another 300 Australian women have registered for a second class action against American Medical Systems over 10 of its different mesh implants.
https://www.buzzfeed.com/ginarushton/women-claim-this-surgery-has-cost-them-their-happiness-sex?utm_term=.rllB9n71Z#.nib9xzwgQ
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Thousands of women left in agony after ‘gold standard’ surgery
May 25, 2017 | New York Post
By Shaunna Murphy
An operation considered a no-brainer for many moms has ruined their lives.
When 33-year-old Melynda Harrison Fitt visited a urogynecologist (a gynecologist who specializes in pelvic floor issues) about some pressure in her lower pelvis back in 2006, the personal trainer and mother of three had no clue the so-called “gold standard” solution pushed by her doctors would lead to a lifetime of agony.
But Fitt, now 44, has since grown resigned to the side effects of transvaginal mesh, a net-like implant used to treat urinary incontinence and pelvic organ prolapse (POP) that has caused hundreds of thousands of women a pain likened to “broken glass or petrol burning inside you.”
And while Australia is treating transvaginal mesh as “one of the greatest medical scandals and abuses of mothers” in the nation’s history, Fitt and many others are wondering how the mesh crisis — which has led to 127,000 lawsuits in the States alone, and cost $20 billion in legal cases worldwide — isn’t garnering the same amount of outrage here at home.
“I will never be able to have pain-free sex again,” Fitt told The Post. “I will never be able to travel overseas, because I can’t sit down for longer than a couple of hours. I will never be able to be a personal trainer again; I can’t clean my house. You wouldn’t believe what you need your vagina for.”
Up to 50 percent of women over the age of 40 eventually experience symptoms of urinary incontinence or POP, the latter of which occurs when the bladder drops from its normal place in the lower belly and pushes against the walls of the vagina. This often happens when the muscles that hold pelvic organs in place are weakened or stretched from childbirth, with roughly 300,000 women undergoing POP surgery annually in the United States.
Transvaginal mesh, which was first approved by the FDA in 2002, replaced an earlier procedure called native tissue repair that used absorbable sutures. This procedure had a 30 percent failure rate, so medical professionals turned to the mesh when they recognized its success in treating abdominal hernias.
But as Mary Jane Minkin, a clinical professor of obstetrics and gynecology at Yale Medical School, told Women’s Health, the mesh “wasn’t appropriately tested for long-term outcomes,” with no clinical trials being held before the treatment hit the market.
As soon as Fitt woke up from surgery, she experienced “lots of pain … beyond your normal pain,” in addition to difficulty breathing and hives. Eight weeks later, she noticed a small spot in the entry wall to her vagina. Doctors told her this was scar tissue that would soon go away, so the young mom ignored the issue and entered graduate school to earn her PhD.
Within months, Fitt had earned a reputation among her professors as “that girl who has to lay down in the back on the floor” because she was unable to sit through class. She began to experience chronic vaginal discharge, which her doctors claimed was due to yeast infections. Her husband occasionally cut his penis on the mesh during sex, but Fitt’s doctors still told her that over-the-counter treatments, exercise and antidepressants should solve her myriad problems.
“They tried to blame the pain on my lifestyle when they couldn’t figure it out,” Fitt said. “But I’m a former personal fitness trainer! I’ve never smoked; never drank.”
Finally, in late 2012, a family friend who is a nurse alerted Fitt to transvaginal mesh litigation commercials, and she realized that she wasn’t the only one experiencing problems.
Fitt saw a new doctor out in Utah, where her darkest fears were confirmed: the “scar tissue” was, in fact, mesh that had eroded into her rectum. She had no native tissue left over the apex of her vagina, and would require six hours of surgery to cut out the exposed mesh. (Only a handful of doctors in the US are qualified to perform this surgery.)
“If you can imagine a splinter in your finger that you can’t get out, and it gets all red and inflamed when your body tries to get it out, essentially that’s what happens with mesh in about 33-34 percent of women,” Fitt explained. “What I had been told for a year and a half was a yeast infection was in fact pus breaking out of that exposed wound in my vagina, where there’s no tissue. I was one bowel movement away from developing a fistula, which is when feces comes out of your vagina.”
By the time Fitt had her life-saving surgery, the FDA had, in 2011, already issued a bold-print warning that “serious complications” associated with transvaginal mesh are “not rare.” In 2016, the agency reclassified mesh as a class III or high-risk medical device, insisting that manufacturers would have to receive pre-market approval for safety and effectiveness to continue selling the product.
But for Fitt and others, the FDA’s actions were far too little, way too late. As of January 2016, there were more than 42,400 mesh lawsuits pending against Johnson & Johnson alone. The same year, the medical device-maker agreed to pay more than $120 million to resolve 2,000 to 3,000 suits alleging that women suffered organ damage and were left in constant pain as a result of the mesh.
“These are thousands of cases that are strong enough that they could go to trial individually on their own,” Fitt said. “But there are so many of them that if every case were to be tried individually, the entire court system in the United States would be overwhelmed for years.”
So while Fitt — who is unable to hold a full-time job and has been diagnosed with PTSD due to her chronic pain — awaits the outcome of her own case against the company, she’s vowed to dedicate her time and attention to making sure others don’t share her fate. She’s an admin in the “Fighters And Survivors of All Transvaginal Mesh” Facebook group, and has fought to bring her story and others to the media’s attention — before even more women die from complications.
“We just lost someone in our group yesterday,” Fitt said. “She went to a doctor that said he could remove the mesh, but he only did a partial removal. She was having trouble walking, and a week ago she fell down some stairs. She didn’t have stability and balance because of the mesh injury. She hit her head, developed a brain bleed, and died yesterday.”
“There are not enough zeroes in the world for me to sign a non-disclosure,” Fitt said. “No one wants to talk about a middle-aged woman’s broken vagina. That’s not sexy.”
https://nypost.com/2017/05/25/thousands-of-women-left-in-agony-after-gold-standard-surgery/
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May 25, 2017 | Ballarat Courier
By Melanie Whelan
BALLARAT mother Fran Harris wants to describe the destruction a mesh implant, intended to fix her prolapse, has inflicted on her life from the inside-out.
Ms Harris wants to voice the heaviness and bleeding she has felt from the way the mesh has eroded multiple spots on her vaginal wall. The chronic pain and tiredness that followed. Inability to have sex.
There is also the mental anguish, including fears of oncoming crippling pain while at work and a relationship breakdown.
Ballarat is shaping up as a hot-spot for women with bad reactions to the controversial procedure.
Victorian-based health consumer advocate Health Issues Centre has had almost 1800 respondents nationwide to a survey on the impact of transvaginal mesh implants. Ten women have been from Ballarat.
Of those with implants, about half are citing negative effects and complications.
HIC’s research will be used as part of its submission to a Senate inquiry into what Senator Derryn Hinch described as "one of the greatest medical scandals and abuses of mothers in Australia's history".
There is no central record of implants performed in Australia, according to HIC, and few reports on adverse impacts.
Ms Harris did not really know a lot about the implants, or the risks, when advised to have surgery in 2011, aged in her mid to late 30s. She “just wanted it all fixed” and trusted the medical professionals.
After surgery, Ms Harris said something did not feel right.
Ms Harris has since undergone four revision surgeries to “trim” the implant, each adding scar tissue and pain. In one appointment with a specialist in Melbourne, Ms Harris was told she needed more surgery despite not having an examination.
Others, like a urologist, have told her she would just have to put up with the pain.
“I am only 43 now, I still have a lot of life to live,” Ms Harris said. “It’s hard to talk about because it’s something you can’t see and people don’t think you look unwell but I’m in constant pain.
“I’m sick of it. This has taken over my life.”
By telling her story publicly, Ms Harris hoped to prevent more women having the procedure, or at least to question it more.
“There is too much more to worry about when things go wrong,” Ms Harris said.
Ms Harris has found a surgeon in Sydney, now specially trained to remove different types of mesh. Her procedure will be more complicated, due to multiple revisions, but she hopes it will restore some of her life back.
HIC is calling on women to complete the survey via facebook.com/pg/UnderstandingPelvicMesh/about/ by Wednesday.
http://www.thecourier.com.au/story/4686826/mesh-implant-nightmare/
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Morcellator Activist, Victim Amy Reed Dies at 44
May 25, 2017 | Mesh Medical Device Newsdesk
Drs. Amy Reed and Hooman Noorchashm put a public face on the failures of the U.S. Food and Drug Administration and how it regulates medical devices.
Amy Reed, the Philadelphia physician who put a public, tragic face on the outcome of unregulated medical devices has died of a rare form of uterine cancer.
A mother of six, Reed, 44, an anesthesiologist, along with her husband, a cardiothoracic surgeon, went public about the dangers of treatment of fibroids and hysterectomy with the morcellator medical device.
In doing so, they came face-to-face with the medical establishment they had long been part of.
An electric morcellator was used on Dr. Reed in 2013 during her hysterectomy at Brigham and Women’s Hospital in Boston, where both doctors worked. Her gynecologist used the device to grind the uterus while still in the body so it can be removed through cuts in the abdomen.
Though the procedure is marketed as “minimally-invasive” in fact, it can spread fragments of undiagnosed leiomyosarcoma, a uterine cancer, throughout the body.
The aggressive cancer grew over the next 42 months while Dr. Reed and her husband Hooman Noorchashm, conducted their very public campaign to have morcellator surgery banned.
Dr. Noorchashm’s social media petitions, emails to regulators and politicians, and calling out of the medical establishment has been effective in bringing awareness to the issue and in sparking a GAO investigation. See Philly.com here.
A number of women reached out to Dr. Reed to say they learned from her experience and opted not to have surgery using a morcellator.
THE FDA
After denying the risk of morcellators, believing they posed a 1 in 10,000 risk to women of spreading cancer, the FDA finally issued a warning admitting that the chance of spreading an undetected cancer is really 1 in 350.
Meanwhile, the agency had approved 25 morcellator surgical devices over two decades under the 510(k) clearance requiring only that they were similar to other devices already on the market.
Medical societies, too, were reluctant to make changes to their go-to medical procedures. See a MND story here.
In February, the U.S. Government Accountability Office (GAO) issued a critical report about the FDA, saying it approved electric morcellators, despite knowing there was a risk of spreading cancer.
That investigation was requested by former U.S. Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY) in August 2015.
According to the GAO report, had Dr. Reed’s aggressive cancer been removed whole, she would have a 50% survival rate at five years.
Instead, after the morcellator spread cancer debris within her body, those chance of survival drop from 0 to 20%.
“This GAO report is de facto confirmation that hundreds, if not thousands, of American women have been harmed or died because of this regulatory failure and the failure of the reporting system,” said Dr. Noorchashm reports Philly.com
MORCELLATORS TODAY
While the FDA “discourages the use of laparoscopic power morcellating during hysterectomy” or a fibroid removal (myomectomy), it does not ban the procedure, according to an April 2014 FDA Safety Communication (here).
In an Updated Safety Communication, November 2014, the FDA says morcellators should not be used on patients with a known or suspected malignancy. Again no ban, but an encouragement to use a containment system to collect the debris from uterus and fibroid grinding in the body.
The FDA cleared the first of its kind tissue containment system, PneumoLiner, in April 2016. PneumoLiner is made by Advanced Surgical Concepts. The device has not been proven to reduce the spread of cancer during a power morcellation procedure, say critics.
Morcellators highlight the system-wide failure of the FDA.
With no requirements for clinical trials before marketing a device, no requirements for reporting adverse events, and a database that is difficult to navigate for both users and regulators, dangerous devices remain on the market until a high profile case like Dr. Reed’s brings it to the public’s attention.
It took the campaign by the doctors for the FDA to finally begin studying a woman’s cancer risk with morcellators about four years ago, but that was too late for Dr. Reed whose aggressive cancer had spread to other organs.
She died at home in their Pennsylvania farmhouse, surrounded by her children and husband. ###
Read more Philly.com
http://www.philly.com/philly/health/Philly-patient-safety-advocate-physician-Amy-Reed-dies-leiomyosarcoma-morcellator-Penn-FDA.htmlChange.org Campaign
https://www.change.org/p/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy/u/20273885?utm_medium=email&utm_source=71452&utm_campaign=petition_update&sfmc_tk=tb3W4yCO5TOoUVVcZmxOESCamlHBATFsllcALcZttCMq8UA35OfEUOOBKRbkWzJFhttp://www.meshmedicaldevicenewsdesk.com/morcellator-activist-victim-amy-reed-dies-44/
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J&J’ Deceptive Practices Brings $33 Mil Fine
May 25, 2017 | Mesh Medical Device Newsdesk
For years, the healthcare giant has faced scrutiny over the cleanliness of its plants that produce its over-the-counter products.
Now J&J must pay $33 million over its “deceptive practices.”
Fierce Pharma breaks the story this afternoon (here) of the $33 million fine Johnson & Johnson has agreed to pay over its recall of millions of bottles of over-the-counter children’s medicines and the substandard plants they came from.
J&M will pay the money to 42 states and the District of Columbia after an agreement with the New York Attorney General’s office. The company must also reform its marketing practices. See it here.
Years ago, Food and Drug Administration inspectors found contamination in the vats that produced Children’s Tylenol and Motrin, including metal particles, reports Time.com.
That led to a recall in 2010 of over-the-counter products including Infants’ Tylenol and Children’s Motrin. Here is a list of the items that were recalled.
In 2008 to 2010, millions of bottles of Tylenol, Motrin, Benadryl and other products made under the McNeil Consumer Healthcare banner. Not only metal particles but mold and labeling problems plagued the products.
As part of the agreement, J&J and its McNeil division, cannot say that its products meet acceptable Good Manufacturing Practices if a quality recall occurred over the past year.
Just two weeks ago, J&J resolved a similar case in the state of Oregon for $400,000. In that instance, J&J failed to announce a recall and instead sent undercover contractors into stores to retrieve the defective medications so the public wouldn’t know.
In 2008, the Food and Drug Administration conducted a series of inspections finding the Fort Washington, Pennsylvania plant found particulate contamination in the products. McNeil pled guilty and paid a $25 million fine.
Since then, the Pennsylvania plant has undergone $100 million in upgrades and reopened after it was shuttered by the FDA. ##
http://www.meshmedicaldevicenewsdesk.com/jj-deceptive-practices-brings-33-mil-fine/
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SUI, POP Reoperation Low at 5 Years
May 25, 2017 | Renal and Urology News
(HealthDay News) — For women undergoing surgery for stress urinary incontinence (SUI) and pelvic organ prolapse (POP), the risk of repeat procedures is less than 10%, with increased risks for older women and initial POP surgery, according to a study published in the June issue of Obstetrics & Gynecology.
Jennifer M. Wu, MD, MPH, from the University of North Carolina in Chapel Hill, and colleagues conducted a retrospective cohort study using a nationwide database to examine the 5-year risk and timing of repeat SUI and POP procedures among women aged 18 to 84 years. The index procedures were identified for SUI or POP after at least 3 years of continuous enrollment without a prior procedure. Based on the index procedure, women were defined as: SUI surgery only (48,196 women), POP surgery only (49,120 women), and both SUI and POP surgery (40,687 women).
The researchers found that after any index procedure, the overall cumulative incidence of a subsequent SUI or POP surgery within 5 years was 7.8% and 9.9% for women younger than 65 years and age 65 years or older, respectively. Lower cumulative incidence was seen if the initial surgery was SUI only, while cumulative incidence was higher if an initial POP procedure was performed (POP only or SUI and POP).
"The 5-year risk of undergoing a repeat SUI or POP surgery was less than 10% with higher risks for women 65 years or older and for those who underwent an initial POP surgery," the authors write.
http://www.renalandurologynews.com/urinary-incontinence/stress-urinary-incontinence-pelvic-organ-prolapse-repeat-surgeries-uncommon/article/663607/
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Report: Women More Affected by Dangerous Drugs and Devices
May 25, 2017 | DrugWatch
By Elaine Silvestrini
In the last 150 years, women have been sold harsh chemical solutions they were told would make them clean and attractive to their husbands. They were given addictive pain killers and tranquilizers, including one known as “Mother’s Little Helper,” to treat their “hysteria” and nervous exhaustion. They were prescribed contraceptives that sometimes killed them.
These are just some of the stories recounted in a new report that asserts that dangerous drugs and devices do disproportionate damage to women. The report chronicles decades of deadly medical products that have killed and maimed thousands of women and their offspring.
Examples include the Essure birth control system, a permanent contraceptive made up of two coils implanted into the fallopian tubes. Thousands of women say they suffered life-changing injuries from the device. And there are power morcellators, instruments used in laparoscopic surgery to mince the uterus allowing for its removal. But the FDA says the devices are spreading a potentially deadly and aggressive form of cancer in thousands of women.
Transvaginal mesh, is an implant used to treat pelvic organ prolapse and stress urinary incontinence. But this device can fail, causing pain, bleeding and infection, and can be impossible to completely remove. And some hip replacements have malfunctioned, shedding metallic debris, and causing injures such as fractures, dislocations, nerve damage and infections.Women Disproportionately Targeted, authors say
The American Association for Justice (AAJ), an organization that supports trial attorneys and aims to promote a fair and effective justice system, says its report shows that some drugs and devices tear women apart from the inside out, and demonstrates how the civil court system has helped enhance safety when regulations and other safeguards don’t.
The 44-page report, entitled From Accutane to Zonite: A History of Dangerous Drugs & Devices Marketed to Women, details bogus and harmful medical treatments sold to women, dating to the late 1800s when women were diagnosed with hysteria and treated with morphine. Then, in the early 1900s, women were urged to use Lysol as a douche and contraceptive.
“From snake oil ‘hormone treatments’ to deadly contraceptive devices, the last 150 years have been littered with dangerous drugs and devices that disproportionately target women,” the report says. The products were linked to the idea that women were “physiologically inferior to men,” the report says, and they were “enslaved and tortured” by the functioning of their reproductive systems, suffering through menstruation and menopause.
Compounding the problem, women are more physically vulnerable to the deadly effects of these products because they take more medications and react different than men, suffering adverse effects more frequently, the report says. But before 1993, the law didn’t require human subject research to include women.AAJ President: End ‘Silent Suffering’
The report asserts that women are still underrepresented and excluded in studies, and the U.S. Food and Drug Administration doesn’t mandate companies to determine which doses of medications should be given to women, compared to men.
“This timely report sheds light on the disturbing ways women have been preyed upon by corporations in the name of profit,” Julie Braman Kane, President of AAJ, said in a statement. “More than a century of gender inequality in research and unhindered corporate greed continue to put women at risk of exposure to dangerous drugs and medical devices. We must protect women’s access to justice to ensure they can end their silent suffering and hold corporations accountable when corporations refuse to put Americans’ safety first.”
Referring to legislation pending in Congress that would make it harder to sue healthcare providers, Kane said, “Congress should be ashamed of masquerading corporate handouts as patient protections. This vengeful legislation severs Americans’ access to the courts, impedes state laws, and protects only those drug and device manufacturers and health care providers that cause our loved ones harm.”
The bill, named “Protecting Access to Care Act,” would provide immunity to providers who prescribe or dispense drugs and devices that received approval from the Food & Drug Administration. The bill would also create a 3-year-statute of limitations for filing lawsuits alleging negligent health care caused injury or death and would impose a $250,000 limit on court awards for “noneconomic damages” such as pain and suffering.Justice at Risk, Report says
According to The Washington Post, the sponsor of the proposed law, U.S. Rep. Steve King (R-Iowa) says it is necessary to “preserve fiscal sanity and federal health policy…As more companies pay in healthcare costs, the less they can pay in wages.”
But the AAJ says the legislation would deny injured patients access to justice even if the provider’s actions were intentionally harmful. According to The Washington Post report, the cap would apply to all kinds of malpractice cases, including sexual assault by doctors and abuse and neglect in nursing homes.
The new AAJ report suggests the bill, if enacted, would particularly harm women who have benefited from litigation that has exposed internal corporate communications demonstrating that some companies have worked to suppress evidence of potential serious and even fatal side effects of drugs and devices marketed to women.
The report details more than a dozen examples of medical products aimed at women that had devastating consequences. Examples include marketing bleach as a douche and Thalidomide, an anti-morning sickness drug given to pregnant women that caused thousands of babies to be born with serious birth defects.Birth-Control Devices Kill, Maimed
It also gives several examples of birth-control devices — from different intrauterine devices to hormonal treatments — that killed and maimed women.
One such device was the Dalkon Shield, introduced in 1971 by A.H. Robins, which knew at the time that the device was seriously flawed. The IUD had prongs to embed in the walls of the uterus, and strengthened string that would wick bacteria, pulling it into the reproductive organ.
According to the report, A.H. Robins was warned about the potential dangers of the string as early as 17 days after buying the rights to the shield from its inventor, but they didn’t respond to the alerts.
In three years, the company sold more than 2 million Dalkon Shields. But even after doctors notified the company of problems, the company “deliberately did not investigate many such warnings, and consistently understated the number of cases it was aware of,” the report states.
When all was said and done, at least 17 women died out of more than 200,000 who suffered pelvic infections, miscarriages, stillbirths and infertility, according to the report. Awash in negative news coverage and under pressure from regulators, the company stopped selling the device in the U.S. in 1974, but continued selling it overseas, the report says.
The report also recounts the toxic-shock syndrome scandal of the 1970s to 1980 when women were sickened and killed by an infection caused by super-absorbent tampons.
The report also details efforts to provide legal protections for corporations, preventing them from being held accountable or having to provide compensation to victims of dangerous products.
https://www.drugwatch.com/2017/05/25/women-affected-dangerous-drugs-devices/
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