'The Bleeding Edge' Netflix documentary July 27, 2018 (Friday)

Netflix's 'The Bleeding Edge' Isn't Even Out Yet and Essure Has Already Been Pulled

"I don't know how anyone could let this happen."

by JENNY HOLLANDER

JUL 23, 2018

Years after the first reports of hazardous effects of birth control device Essure—and days before a Netflix documentary about it drops—manufacturer Bayer announced it will stop selling the controversial implant. The company framed its decision as based on poor sales, but the timing is hard to ignore: The Bleeding Edge, a documentary about medical devices gone awry that uses Essure as a prime example, drops on July 27. Essure was pulled July 20.

"We continue to stand behind the product's safety and efficacy," Bayer said in a statement. The company has maintained for years that Essure, a kind of metal coil that is implanted in the Fallopian tubes to block sperm, is safe, despite facing roughly 16,000 lawsuits from women who say they suffered ill effects after using it, including organ perforation, chronic and excessive pain, and unintended pregnancies. Yet Essure was discontinued due to a "business decision," the company said, citing "a decline in sales."

Meanwhile, Friday marks the launch of The Bleeding Edge, a Netflix documentary from the creators of The Hunting Ground. The Hollywood Reporter describes it as "a terrifying eye-opener," and Indiewire writes that it "stands a good chance at enlightening more people who have been (or might be) hoodwinked." The documentary isn't just about Essure—it focuses on a handful of medical devices that have caused major complications, including "vaginal mesh" and hip replacements—but Essure is framed as a banner example of good intentions gone haywire.

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When it comes to Essure, Bayer has suffered a particularly nasty year. Essure has been pulled or withdrawn from every country where it had been offered outside of the United States—Canada, the U.K., the Netherlands, you name it—and in April, the FDA announced it would be restricting sales of Essure to ensure that all women who consider it are fully aware of the risks. (Restricting sales, in this case, means only selling the device to facilities that agreed to review a set checklist with doctors and patients.) That said: "The FDA continues to believe that the benefits of the device outweigh its risks," the statement noted.

Once billed as the only permanent contraceptive device on the market, Essure has since become a buzzword for unexpected complications. On Facebook and other social media sites, there exists a growing community of Essure-affected women who congregate to share their experiences. Between 2002 and 2017, close to 30,000 women filed formal reports of "adverse effects" with the FDA after using Essure.

You can stream The Bleeding Edge on Netflix from July 27.

https://www.marieclaire.com/health-fitness/a22518890/netflix-the-bleeding-edge-essure/

Pelvic Surgical Mesh: "Living in Hell"

Western Australian pelvic mesh victims criticise government response to scandal

Joanne McCarthy

21 Jul 2017, 1 p.m. FiDA highlight

• Women call on WA Health Minister to order investigation into mesh surgery research

Women allege they were used as guinea pigs in pelvic mesh trials in WA public and private hospitals

SUE Turner and Jeanette McKinnon are the Western Australian women implanted with pelvic mesh devices in public hospitals who refuse to be regarded as unfortunate statistics.

They have made submissions to a Federal Parliament Senate inquiry into pelvic mesh – with a public hearing in Perth on August 25 – listing serious, permanent and life-altering consequences of their surgeries more than a decade ago.

They want answers from WA Health Minister Roger Cook about mesh research allegedly conducted in public hospitals, and whether they are included in mesh trials for which they say they did not consent.

They are scathing of Mr Cook’s commitment to “make some enquiries” about the alleged mesh research trials, in response to questions from Fairfax Media, and have called for a full investigation into whether women were used as “mesh guinea pigs” in public health facilities.  

“Something awful happened to me in 2004 and 2005 after I had mesh put into me. My world’s just so small now,” said Mrs McKinnon, who was 46 in 2004 when she was implanted with an Australian-developed pelvic mesh device at Bentley Hospital.

“It’s like living in hell. I’m dying a very slow and agonising death.”

Victorian Senator Derryn Hinch in February successfully argued for a Senate inquiry into how some pelvic mesh devices for women’s incontinence and prolapse problems after childbirth were cleared for use in Australia over the past two decades. He compared pelvic mesh products to Thalidomide, the drug that led to birth defects in babies in the 1960s.

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(Video on link.) Senator Derryn Hinch calls for a Senate inquiry into pelvic mesh.

The aggressive marketing of many mesh devices in Australia from 2003, without sufficient evidence of their safety and efficacy, led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” Senator Hinch said in a speech to Parliament.

Nearly 200 Western Australian women have responded to a survey conducted by Victorian consumer health advocacy group, Health Issues Centre, for a submission to the inquiry representing the experiences of more than 2200 Australian women implanted with pelvic mesh devices.

More than 700 women are part of a current class action against major pelvic mesh manufacturer, Johnson & Johnson, in the Federal Court in Sydney.

Sue Turner, of Perth, has sought legal advice about a class action against an Australian manufacturing company, after she was implanted with an Australian-developed pelvic mesh device at Armadale Hospital in 2007.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial.

- Sue Turner, who had pelvic mesh surgery in 2007.

”

“I had a prolapse. I just trusted the doctor and our health system when he told me it would be a pretty easy fix,” Mrs Turner said.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial. If I was told there was a risk that if things went wrong I would never have a sex life again, or live a life of sometimes unendurable pain, or be left with mesh and anchors in my body that have moved and embedded into tissue very close to major blood vessels and nerves, I would never have consented. But I wasn’t told.”

In a statement to Fairfax Media Mr Cook said he would ask the Department of Health to “make some enquiries into the research undertaken, and the cases where the implants have been used”, after two senior Western Australian doctors released a series of papers from 2005 about trials in Western Australian public and private hospitals, including Armadale Hospital, using the Australian-developed pelvic mesh device.

In a statement by a WA Health Department unit, Fairfax Media was advised there are no records of research approvals for trials involving surgery on women at public hospitals using the Australian-developed pelvic mesh device.

Mrs Turner and Perth-based Australian Pelvic Mesh Support Group founder Caz Chisholm were angered by Mr Cook’s statements that the “WA Government understands the concern this has caused for some patients”, but “there have been very few complaints received by WA Health and the Health and Disability Complaints Office”.

“What are we? Guinea pigs?” Mrs Turner said.

“I want this stuff out of my body but my doctor’s told me the surgery could be life-threatening. This isn’t about numbers. It’s about how our health system allowed these devices onto the market, and how these doctors were allowed to do this surgery in public hospitals without telling us of the risks.”

Ms Chisholm said the lack of complaints was a consequence of women being told for years that their chronic problems, including often debilitating pain, repeated serious infections, and erosion of mesh into organs including the bladder and bowel, were not linked to mesh surgery, or not being told they were implanted with mesh.

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause.

- Australian Pelvic Mesh Support Group founder Caz Chisholm

”

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause. It is only because of recent media attention about stories of women's pain and complications that women are realising their own complications are identical to the media stories,” Ms Chisholm said.

“The minister says there have been very few complaints by women, but what about the doctors treating the women? Obviously doctors aren’t reporting complications either, and are they supposed to?”

Mrs McKinnon has spent more than a decade on antibiotics.

“I came out of hospital not very well in 2004 and had my first urinary tract infection shortly after that. Then it was one urinary tract infection after another. If I come off the antibiotics I get a urinary tract infection,” she said.

She had another four major surgeries over the following year to relieve the pain and address mesh erosion into organs. 

In 2009 Mrs McKinnon was diagnosed with the auto immune condition lupus, requiring steroid treatment.

“I was normal, healthy and fit before I had that surgery. I’m only 59 and I feel like a 100-year-old. I thought all these years it was just me. It’s just the nightmare that you live.”

In a statement in June the Royal Australian College of Obstetricians and Gynaecologists said the majority of women treated with mesh for incontinence or prolapse had “a good long-term result” but “in a small number of cases the complications have been very serious”.

In a submission to the Senate inquiry Victoria’s Health Issues Centre chief executive Danny Vadasz has criticised mesh debate “framed in terms of the good outcomes of the many outweighing the unfortunate experiences of a few”.

“Our health system is built on values such as equity and a universal duty of care, not on a cost/benefit analysis that accepts the unavoidability of collateral damage,” he said, in a Health Issues Centre submission arguing Australian regulators have been “asleep at the wheel” on pelvic mesh.

Do you know more? Email jmccarthy@fairfaxmedia.com.au

http://www.theherald.com.au/story/4804268/its-like-living-in-hell/

The Biggest Global Health Disaster of Our Time: Surgical Mesh

Women step up pressure to ban pelvic mesh implants - the biggest health disaster of our time

PUBLISHED: 20:06 06 June 2017  FiDA highlight

Kath Sansom

One in three women could be suffering in silence with mesh implant problems in a women’s health scandal that has been called the biggest disaster of our time.

One of the risks of pelvic mesh implants is loss of sex life due to chronic burning and cutting pains or chronic infec tion. This has led to marriages breaking down. The risks are unacceptable say campaigners globally. PHOTO: Pexels.

The shocking figures come as a Scottish surgeon this week told BBC Radio that mesh has a: “Whopping 15 per cent of women who develop serious complications.”

Speaking on the Kaye Adams show, Dr Wael Agur said: “No woman should get a life long disability just because of a surgical treatment of urinary incontinence.

“One life ruined is one too many and it’s absolutely unacceptable that a patient will take pain killers for the rest of her life.”

Instead, he said surgeons should move back to two alternative, time honoured surgical fixes, with risks which are acceptable.

The mesh implant scandal was featured on the BBC Victoria Derbyshire show in April. Seen here interviewing reporter Kath Sansom, Claire Cooper and Kate Langley.

Campaigners globally say pelvic mesh risk, quoted in all countries as one to three per cent, is vastly under estimated and based on studies which are either short term, run by medics with conflicts of interest or on animals who cannot speak of the pain or lost sex lives due to intense burning and cheese wire pains in their vaginas.

As the scandal unravels women are calling on governments worldwide to ban mesh implants, used to fix incontinence and prolapse, often caused by pregnancy and childbirth.

Campaigners, Elaine Holmes and Olive McIlroy fought for a suspension on mesh in Scotland in June 2014 but it was re-instated in March 2017 amid claims of a whitewash independent review - now being scrutinised by an independent expert.

Scottish MPs Neil Findlay and Jackson Carlaw have called this a disaster on asbestos proportions.

Leaked document of the English Group Working Party into mesh implants - group members agreed to try to reduce media impact of mesh relating to Yellow Card reporting. Patient reps have not been invited to any meetings for more than a year. PHOTO: Contributed

Welsh MP Owen Smith has called it the worst health scandal he has seen in his time as a politician.

Australian senator Derryn Hinch has said this is the biggest women’s health issue since the morning sickness drug thalidomide.

American lawyer Ben Anderson said: “This is the greatest women’s health crisis of our generation.”

New Zealand politician, Christine Rankin, who suffered agonising mesh implant pain and was told by her surgeon to get used to living with it, said: “Mesh is dangerous and it should be used with caution and the truth needs to be told about it.”

The MHRA commissioned a study into mesh complications. The result is the York Report from 2012.

Problems reported by women globally include leg pain making it difficult to walk far, pain in buttocks and groin making it painful to sit for long, the sharp-edged mesh cutting into tissues, nerves or even busting through vaginal walls, chronic infections and allergic reactions to the plastic material.

Some women are left disabled in wheelchairs and others have to use sticks to help them walk.

Studies with high risk figures include:

• An American study which show 42 per cent of women suffer complications - 20 per cent of them serious.

• An Italian study which found risk rate was 30 to 40 per cent.

• An American review which says the risk of pain following a mesh operation is 31 per cent.

• A Canadian study which found problems for 27.9 per cent of women.

• A Canadian review that says 22.3 per cent of women risk suffer painful infections.

• A Canadian study discovered poor outcomes for at least 15 per cent of women.

• The FDA say the hooks used to implant mesh can cause damage for up to almost 30 per cent of women.

Almost 20 years after the operation was launched, women say the world must wake up to the fact that mesh implants are not a “gold standard” fix.

Surgeon Firouz Daneshgari, said: “By any modern industrial standards of quality, a 30–40 per cent rate of adverse events is simply unacceptable.

“Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?

“Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.”

In the UK, the NHS and MHRA say the benefits outweigh the risk, which they say is as low as one in 100 women.

However, they base their figures on a review called the York Report, carried out in 2012.

Campaigners say the studies in it are flawed as many are short term - as little as six weeks post operation - so do not capture the true picture. Some problems don’t cut in until months or years later.

The UK York Report says the risk of losing or suffering a reduced sex life can be as high as 13.5 per cent while the risk of pain can be as high as six per cent and erosion as high as 5.8 per cent.

However, it averages out its figures of risk to just one to three per cent - a figure quoted in most UK patient information leaflets.

Sling The Mesh campaigner Ann Boni said: “How bad has this got to be before the authorities admit mesh has lifelong disabling risks?”

If a woman suffers complications, then removal is major surgery, Mrs Boni added, but said many surgeons push women to only have part of the mesh tape taken out.

A partial removal takes around half an hour while a full removal can take up to two hours - making it clear that partials are preferred on a cost basis.

A survey carried out by patient support group, Sling The Mesh, found that a full removal can relieve symptoms for almost six out of ten women - 57.14 per cent.

A partial removal, however, left only two out of ten women - 21 per cent - feeling like it had improved things.

Mrs Boni said: “Mesh is designed as a permanent implant and was launched onto the market without the benefit of robust, quality clinical trials. “No thought was given to how it was going to be removed when complications arose.

“It is easier to perform a partial removal but what must be impressed on surgeons is that if women seek removals they must be given full removals because at least the patient stands a chance of getting some quality of life back.

“Partial removals can leave women worse off months or years down the line as mesh continues to shrink, migrate into pelvic organs, harbour infection and the foreign body reaction continues to activate an adverse immune response”

“Surgeons know that if there are problems it is very difficult to fix. So why do they still implant it?”

• A study called Prospect said more than one in ten women suffer complications following a prolapse mesh operation.

• A study, which includes UK mesh removal specialist Suzy Elneil as author, says there should be a red card system for new medical devices. It also says not all women should be considered for mesh as previous pelvic or lower abdominal surgery may mean adhesions. Also some women may have a congenitally distorted pelvis or been traumatised by other causes such as childbirth. http://www.europeanurology.com/article/S0302-2838(11)00868-2/pdf

http://www.wisbechstandard.co.uk/news/women-step-up-pressure-to-ban-pelvic-mesh-implants-the-biggest-health-disaster-of-our-time-1-5051244

MedShadow: Questions for Robert Califf, MD

Questions for FDA Commissioner Nominee

By Suzanne B. Robotti  @Med_Shadow   www.MedShadow.org  MedShadow Foundation

http://bit.ly/1lWDfwz

Published: November 24, 2015  FiDA highlight

Many people have questioned whether cardiologist Robert Califf, MD, has the ability to maintain (or rebuild, depending on one’s point of view) the wall between the FDA drug approval process and inappropriate intervention from pharmaceutical companies if he is selected to be the next Commissioner of the governmental agency. Dr. Califf has worked closely with most pharma companies and the very fact that those companies aren’t opposing his nomination encourages speculation that the FDA will slip even further into closer alignment with pharma’s goals.

Questions regarding Dr. Califf’s ties to the pharmaceutical industry are important and need to be fully explored. However, independence is only one worthwhile question for him. I have many more for Dr. Califf or any FDA Commissioner nominee:

1

What will you do about the 2.3 million people who are rushed to the ER each year due to side effects of drugs prescribed to them? Or those 117,752 deaths due to adverse drug events in 2013? That’s nearly 4x as many fatalities from guns, 33,380.

2

You state that you want to institute an adverse events reporting system for medical devices, similar to the existing one for drug reporting. Have you ever tried to look up a drug on that system? As a consumer, I have found it to be a nightmare of charts, repetitious and incomplete information. What will you do to improve the FAERS system?

3

Seniors take multiple prescription and OTC meds daily. About 35% take 5 or more prescription medicines. Older adults are 2x as likely as others to arrive at emergency departments for adverse drug events. Do you see a role for the FDA in reducing medication errors that cause adverse events or an agency effort to decrease the incidence of the over-medication of seniors?

4

What will you do about doctors giving drugs never tested on children to children?

5

The US and New Zealand are the only 2 countries that allow prescription drug advertising directly to consumers (DTC). What is your opinion about the benefits vs the risks of DTC drug advertising? Would you consider joining the AMA in calling for an end to this practice?

6

What is the FDA’s responsibility in ensuring that drugs approved for a specific, narrow group of patients do not become broadly prescribed? Example: opioids and the growing death toll from the overuse and addiction of these painkillers.

7

Off-label prescribing has been shown to have a significantly higher rate of adverse events, according to a Canadian study published this month in JAMA. Is there a way to control and lower the amount of off-label prescribing? Do you see a need for this?

8

What about post-approval studies? Why aren’t pharma companies penalized for not getting them done instead of being granted extension after extension? A “common” side effect is one that happens in 1 in 100 users. When a study includes only 100, 250 or 500 people, that side effect, even though common, may not be detected until the medicine has been approved and is in the marketplace. Post-approval studies are the best way to track and inform people about the growing list of known side effects for any drug.

9

Will you demand that all research, even those studies stopped or not published, be submitted for review during the approval process?

Do you have questions? Write the members of the Senate Committee that is making the recommendation regarding the FDA Commissioner nominee to the full Senate. The committee is named HELP. Write soon as the recommendation will head to the full Senate soon.

All the Senators on the HELP (Health, Education, Labor, & Pensions) Committee are listed in the chart below. 

If one of your Senators is on the committee, please send your Senator’s health care staffer a message. Also send emails to the leaders of the HELP Committee: Chairman Lamar Alexander’s (R-TN) staffer and Ranking Member Patty Murray’s (D-WA) staffer.

If neither of your senators are on the HELP Committee, please send emails ONLY to Senator Alexander’s and Senator Murray’s staffers. 

Staff members for the HELP Committee are listed at the end of the link above. NOTE: If the list indicates more than one staffer for your senator, send your letter to all of those staffers.

Thank you to the National Center for Health Research for guidance in writing Senators on the HELP Committee.

US Senate HELP Committee

Fname	Lname	State	Committee Assignment	StaffFname	Email Address
Lisa	Murkowski	AK	HELP	Garret	garrett_boyle@murkowski.senate.gov
Christopher	Murphy	CT	HELP	Joe	Joe_dunn@murphy.senate.gov
Mark	Kirk	IL	HELP	Mark	mark_stewart@kirk.senate.gov
Rand	Paul	KY	HELP	Natalie	natalie_burkhalter@paul.senate.gov
Elizabeth	Warren	MA	HELP	Remy	Remy_brim@warren.senate.gov
Barbara A.	Mikulski	MD	HELP	Jessica	Jessica_McNiece@appro.senate.gov
Barbara A.	Mikulski	MD	HELP	Amanda	amanda_shelton@mikulski.senate.gov
Al	Franken	MN	HELP	Erica	Erica_Cischke@franken.senate.gov
Bernard	Sanders	VT	HELP	Sophie	Sophie_kasimow@help.senate.gov
Tammy	Baldwin	WI	HELP	Kathleen	Kathleen_laird@baldwin.senate.gov
Bill	Cassidy	LA	HELP	Robb	robb_walton@cassidy.senate.gov
Bill	Cassidy	LA	HELP	Brenda	brenda_destro@cassidy.senate.gov
Sheldon	Whitehouse	RI	HELP	Jennifer	Jennifer_deangelis@whitehouse.senate.gov
Sheldon	Whitehouse	RI	HELP	Anna	anna_esten@whitehouse.senate.gov
Susan M.	Collins	ME	HELP	Betsy	Betsy_mcdonnell@collins.senate.gov
Susan M.	Collins	ME	HELP	Olivia	olivia_kurtz@collins.senate.gov
Susan M.	Collins	ME	HELP	Amanda	amanda_lincoln@aging.senate.gov
Lamar	Alexander	TN	HELP, Chair	Grace	grace_stuntz@help.senate.gov
Michael F.	Bennet	CO	HELP	Rina	rina_shah@bennet.senate.gov
Johnny	Isakson	GA	HELP	Jordan	jordan_bartolomeo@isakson.senate.gov
Johnny	Isakson	GA	HELP	William	william_dent@isakson.senate.gov
Pat	Roberts	KS	HELP	Emily	emily_mueller@roberts.senate.gov
Richard	Burr	NC	HELP	Natasha	natasha_hickman@burr.senate.gov
Robert P.	Casey	PA	HELP	Sarah	sara_mabry@casey.senate.gov
Tim	Scott	SC	HELP	Chuck	charles_cogar@scott.senate.gov
Michael B.	Enzi	WY	HELP	Tara	tara_shaw@enzi.senate.gov
Orrin G.	Hatch	UT	HELP	Jay	jay_khosla@hatch.senate.gov
Patty	Murray	WA	HELP, Rank Member	Melanie	Melanie_Rainer@help.senate.gov
Patty	Murray	WA	HELP, Ranking Member	Wade	wade_ackerman@help.senate.gov