Australian pelvic mesh implant doctor barred from surgery.

Medical Council stops Reid from doing major surgery 

May 18, 2015, 11 p.m.

THE NSW Medical Council placed Dr Richard Reid under practice conditions in 2011, including that he obtain ‘‘valid informed consent for the surgery he performs’’, after complaints and at least three civil settlements against him.

He was suspended in July last year and his offices in Sydney and the Central Coast were closed after the Medical Council determined he posed a risk to the public with his use of the Tissue Fixation System of mesh products to treat women’s prolapse problems after childbirth.

Dr Reid was reinstated in November after appealing to the NSW Civil and Administrative Tribunal, which noted the ‘‘experimental’’ nature of some of his work.

The Therapeutic Goods Administration deregistered the Tissue Fixation System mesh products a week later.

The Civil and Administrative Tribunal was told there were 14 complaints against Dr Reid between 2002 and 2014.

The Medical Council barred Dr Reid from performing major surgery in March. He was also ordered not to treat patients in consultation with deregistered South Australian psychologist Marek Jantos, who was found guilty of gross professional negligence, malpractice and misconduct in 2007 over his treatment of a female patient.

The Health Care Complaints Commission is investigating a number of complaints against Dr Reid.

Maurice Blackburn principal Anna Walsh said her law firm was likely to be issuing court proceedings in a few months on behalf of several women who received the Tissue Fixation System mesh product during surgery by Dr Reid.

‘‘From our investigations so far it seems that many women were not given enough clear information about why they needed to have this procedure with this device and they have been left with very poor outcomes which in many cases are irreparable,’’ Ms Walsh said.

Dr Reid’s colleague Dr Peter Petros, who developed the Tissue Fixation System, is also being investigated by the Health Care Complaints Commission.

Dr Petros did not respond to a request for comment. 

http://www.theherald.com.au/story/3086840/medical-council-stops-reid-from-doing-major-surgery/

Let Harmed Patients In: End 'deny-and-defend'!

After a Medical Error,Patients Could Become Hospital Insiders

Cheryl Clark, for HealthLeaders Media , May 22, 2014

Patients who have been harmed by medical errors, and their family members, could be recruited to hospital internal quality review proceedings and their suffering could be used to prevent future mistakes. It's a good, but potentially disastrous idea.

Hospital quality expert R. Adams Dudley, MD, was flapping his official UCSF identification badge that hung from a lanyard around his neck. He told the group at a recent patient safety meeting that when a hospital patient is harmed, "maybe they and their families should be given one of these."

The point he was trying to make was this:

It's not enough for healthcare providers to merely be honest and apologize when a patient suffers harm, a strategy slowly replacing the standard "deny-and-defend" practice that persists in most hospitals, he says.

And it's not enough to do the thorough root cause analysis, even offering compensation right away, which some organizations are starting to do to avoid litigation and help patients grapple with the tragedy.

They need to do more if they're truly serious about being honest and preventing errors going forward, and this is what Dudley thinks might be the next step to take.

"What if, when someone is harmed in our hospitals, we say not only, 'we're sorry you were harmed', but 'here's a badge. Now you're part of our team. Now, if you choose, you can be a patient advocate, come to our staff meetings, talk about what happened, [and] attend patient safety conferences. We'll e-mail you the meeting schedule.'"

We want you to help tell us how we can prevent this from happening to someone else, he says.

'They Know We Messed Up'


"What better way for us to open ourselves to really, truly be transparent than to say that the people we let watch us should be the ones who know we can mess up, because we messed up with them?"

Dudley's patient badge isn't figurative. It should be a real piece of plastic that lets these patients and their families inside the hospital's inner sanctum, so they may walk the halls with the doctors and nurses. It's important symbolically and psychologically, he acknowledges.

"If we really believe that we [as providers] should be held accountable, why wouldn't we be willing to talk about these issues in front of the people who no doubt feel a strong need to check us out?"

But what if patients and their families see providers arguing with each other about what went wrong, pointing fingers to assign blame? Wouldn't it be a bad idea to allow patients or their families to see that discord?

Not at all, Dudley says.

"If one specialist thinks one thing, and another thinks another, there's no reason to hide that. That's just part of medicine. It happens all the time." It's part of the process of getting to the truth, he says.

Dudley, founder of the California Hospital Assessment and Reporting Task Force (CHART) and many other research initiatives geared to performance improvement, is known for his sometimes unconventional ideas. He acknowledges that many hospital officials will write them off as just more craziness from California's wacky healthcare system, he jokes.

But increasingly, this idea is taking off in a few places, although not quite as intimately as Dudley describes. Patients and their family members are being recruited in very public ways to the patient safety movement —although rarely inside the hospital's often tense and internecine adverse event review committees —to use their experiences to help fix flaws in the system.

Former Patient Outsiders Are Now Insiders


Helen Haskell of Mothers Against Medical Error, whose son died from one, now sits on numerous national safety panels. The parents of Rory Staunton, the 12-year-old who died of sepsis that a New York hospital failed to recognize, began a working relationship with state regulators and the Centers for Disease Control and Prevention to increase sepsis early detection. 

Then there's ePatient Dave, MRSA survivor Jeanine Thomas and dozens of other national examples of outsiders who are now insiders.

Of course, there's a point at which this could be a disaster, accomplishing the opposite of its intent, provoking nonproductive disruption from patients and family members who are still too angry and confused to make cogent contributions. Dudley acknowledges that he hasn't even proposed the idea yet to UCSF, although he might.

Because of that concern, I ran the idea by attorney Richard Boothman, chief risk officer and director for clinical safety at the 925-bed University of Michigan Health System. In 2001, Boothman replaced what he says was the classic "deny-and-defend" model for responding to adverse events with "the Michigan Model," in which patients are told up front what happened, followed by three specific actions:

1.              Compensate patients quickly and fairly when unreasonable medical care caused injury.

2.              If the care was reasonable or did not adversely affect the clinical outcome support caregivers and the organization vigorously. (A child with an ear infection who has a severe reaction to an appropriate antibiotic)

3.              Reduce patient injuries [and therefore claims] by learning through patients' experiences.

The result, published in the Annals of Internal Medicine in August, 2010, was that the average rate of new claims dropped from 7.03 to 4.52 per 100,000 patient encounters and the rate of lawsuits dropped from 2.13 to .75.

Also, median time from claim reporting to resolution dropped from 1.36 years to .95 years. And costs incurred for paying total liability, patient compensation, and non-compensation-related legal costs all declined, from $405,921 per lawsuit before the program was implemented to $228,308 after, a trend that persists.

But Boothman, who attended the same patient safety meeting where Dudley waved his badge, says, "It sounds great until you try it." UMHS did try it a year ago and encountered two insurmountable problems.

First, he says, "there's a practical problem that hit us right in the chops. When something bad happens, the clock starts ticking, and we have an immediate need to do our investigation to understand what happened so no one else gets hurt.

But patients are dealing with new medical needs, or sometimes they [or family members] are grieving. It sometimes takes them six months before they can talk with us, and I can't wait six months. I won't put other patients at risk."

Second, UMHS found "nobody will be honest unless they feel they're in a safe place. You have to create an environment where people can speculate, sometimes offer wild ideas about what happened."

He gives this real UMHS example: "A doctor operated on the wrong spine level, and during the event review everyone involved—doctors, nurses, techs—were in one room going minute by minute to figure out what happened. Afterwards, two nurses called me in tears saying 'You never got the truth.

"That surgeon was working in two different operating rooms at one time, and the residents were in over their heads. The surgeon got disoriented and operated on the wrong level.' "

"Well, why didn't you say anything?" Boothman asked them.

They didn't dare, they replied. "The surgeon was sitting across from us."

That's the problem, Boothman says. "If you put a grieving angry patient in a room like that and expect anyone will speak openly, it will never happen."

I like Dudley's idea because I think patients who believe they've suffered a hospital-caused harm see the system suddenly pivot against them.

Where before they may have felt important and secure, now they see backs turned and calls unanswered. The idea of letting them inside, making them members of this special club so they won't feel abandoned and victimized, and litigious, seems like it couldn't hurt.

But maybe there have to be limits to how far providers actually let them in.

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.

ProPublica Quantifies & Personalizes Hospital Patient Harm: Interactive

Press this link and participate in this interactive session on hospital hazards.

The Story Behind Our Hospital Interactive

by Tom Detzel
ProPublica, May 17, 2013, 1:15 p.m.

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Here at ProPublica, we love to find new ways to tell stories. We’ve built data-driven news apps, commissioned our own news songs and crafted narratives with a novelist’s touch, all to enrich our investigative reporting.

“Your Hospital May Be Hazardous To Your Health,” co-published today with PBS Frontline, is our newest try at innovation. And it had an unusual gestation – as part of a five-day hackathon that brought together teams of journalists, filmmakers, developers and designers to produce interactive stories for the Web.

The piece draws from ongoing reporting about patient safetyby ProPublica reporters Marshall Allen and Olga Pierce. Our collaborators were documentary filmmakers Tom Jennings and Sabrina Shankman and Director of Development Sam Bailey, all with Frontline, and a team from Ocupop, a web design and development group based in Milwaukee, Wisc.

The hackathon – “Tribeca Hacks: Storytelling Innovation Lab” – is a project of the Tribeca Film Institute and Mozilla that is supported by the Ford Foundation.

What is torture? What is criminal? Australian women sue J&J.

ABC News 7.30 Australia
Click on the link and watch this short news video. It is essential to understanding the story below.

Johnson & Johnson facing massive class action

10/15/2012 By Matt Wordsworth   ABC News 7.30 Australia (FiDA highlight added.)

Medical giant Johnson & Johnson is facing its third class action in Australia in as many years.

The case filed in the Federal Court yesterday relates to a product called transvaginal mesh.

It has helped many women who have suffered prolapsed organs by assisting their muscles with support, but for a significant number it has caused life-changing harm.

Lawyers believe it could be the largest product class action in Australian legal history.

It has also cast fresh light on the system of approvals because the mesh was introduced without any pre-market testing, with surgeons leading the call for change.

When Julie Davis was younger she had a plan to travel the world, meet the man of her dreams and settle down to have a family.

She succeeded, but along the way she endured a traumatic birth and some terrible consequences.

"I'd had a very bad forceps delivery with my first child who's now 10 and I had to wait until all my children were born to fix a very significant bladder prolapse," Ms Davis said.

"From my understanding it was the worst kind of prolapse because the bladder was actually outside my body."

It is a common problem, but there was a relatively new product to Australia - transvaginal mesh - that could be stitched in near the top of the vagina to help the pelvic floor muscles support the internal organs, much like a sling.

"The surgery itself was way more traumatic and devastating than I had imagined," Ms Davis said.

"I just felt unwell all the time, I was in pain, a lot pain, discomfort down below. I also had this feeling - lack of energy, like my body was fighting something all the time."

While her husband shouldered the load of earning an income and running the household, Julie, who was only in her 40s, was forced to use a mobility scooter.

For her, walking was painful, so too was sex, and the emotional toll was almost too much.

"It did get to the point where I just actually was chronically depressed and I had to go to see a GP and go on antidepressants," she said.

"There was one point [when] I was driving my car and I was just thinking, 'jeez, it would be easy just to turn the wheel at Curl Curl headland and just go off' because I felt that desperate."

'Adverse events'

It was after this that Ms Davis sought out a new surgeon, urogynaecologist Richard Reid.

He says the mesh was acting like a cheese grater in her body and had literally rubbed a hole in the wall of her vagina.

"When the mesh is put underneath the bladder, the bladder moves back and forth as it fills and it moves back and forth during intercourse," Dr Reid said.

"Because mesh scar is fundamentally quite fibrous and the bladder is very soft, we call this compliance mismatch, which means the same as rubbing a piece of cheese over a metal grater; the metal grater is obviously harder than the cheese."

Research published last May in the New England Journal of Medicine found mesh kits had "higher short-term rates of successful treatment" but also "higher rates of surgical complications and post-operative adverse events".

Two months later, in July 2011, the Food and Drug Administration (FDA) in the United States issued a formal warning saying they were a "greater risk" with "no evidence of greater clinical benefit".

Johnson & Johnson removed its product from sale earlier this year and class actions are already underway in America and Canada, and now Australia.

Rebecca Jancauskas, who is representing Ms Davis as the lead plaintiff in the class action, estimates as many as 20,000 Australian women may have had transvaginal mesh implanted, and that is despite the product having undergone no clinical trials.

"This prolapse mesh class action that we've commenced in the Federal Court today has the potential to be the biggest product class action that Australia has ever seen," Ms Jancauskas said.

Certain classes of medical devices may be sold without adequate testing if they are going to be used in a similar way to existing products.

Mesh kits had already been very successful in treating urinary incontinence, an area where there is not the same friction from internal organs.

"So the system was set up and the device companies have used the system," Dr Reid said.

"I think that with the wisdom of hindsight, it would have been more prudent for them to have done more testing before it was released, but in many I see the primary fault is the system didn't think out what was going to happen."

Previous class action

It is not the first legal trouble for Johnson & Johnson in Australia.

Last year a class action was launched over its DePuy hip replacement device which left hundreds of patients poisoned and seriously disabled.

In 2010 the company faced similar legal proceedings over its knee replacement products.

Just like the mesh kits, neither product had undergone pre-market clinical trials.

"Given that this is now the third product class action that Johnson & Johnson has faced in three years, it should raise some serious concerns about their product safety standards," Ms Jancauskas said.

The company has issued a statement saying:

Johnson & Johnson Medical continues to have confidence in the safety and efficacy of these products.

The decision to discontinue these products was based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.

This is not a product recall, and based on this notification it is not necessary for women who have received one of these products to take any action.

For more than a decade, our organisation has invested in the research, development and clinical study of products to treat a wide range of pelvic disorders.

We remain committed to advancing the standard of care for women's health and will continue to offer safe and effective treatment options for women.

Some are angry at the Australian regulator, the Therapeutic Goods Administration (TGA).

Senator Nick Xenophon, who was part of a parliamentary inquiry into the hip devices, says he is concerned that similar problems are still happening.

"Well this is another instance of regulatory failure. The TGA is meant to be a watchdog of these devices but it's failed time and time again," Senator Xenophon said.

"This is the third serious instance in the last 12 months. After the problems with hip replacements, breast implants and now this, [it] indicates there are some serious systemic problems with the TGA."

And while America's FDA issued its warning to consumers last year, there has been no such move from the TGA.

In a statement, it explained that it held a detailed review in 2010 and found the complication rate was low and depended on the skill of the surgeon, but that it would continue to monitor the situation.

Ms Davis says "it's been a tough road" and she has now had her mesh surgically removed.

She and husband Tim are desperately hoping that after four years and five surgeries, there is something to look forward to.

"I hope that we're over the hill now and start rebuilding our lives again in the way that we planned to begin with," Mr Davis said.

"We had great plans and great ideas of how we wanted to build our life, with the children et cetera, and I feel that life has been running away from us and we haven't been able to sit back and enjoy some of it."

Statement from the TGA in response to  ABC News 7.30 (Australia) - go to link above, please.

Apologies must include Patient Harm/Transparency

 LINK

Investigating Untold Health Stories

By William Heisel  Reporting on Health

At its heart, the debate comes down to this: Should a doctor be able to say sorry to a patient who has been harmed and then avoid the repercussions of the error?

Doug Wojcieszak, the founder of the Sorry Works! program, makes a strong case for changing state and federal laws to encourage apologies and discourage protracted malpractice lawsuits.

A group of patient safety advocates led by Lisa McGiffert from Consumers Union's Safe Patient Project and Robert Oshel, the designer of the National Practitioner Data Bank's Public Use File, argue that the Sorry Works! plan would allow doctors to hide dangerous histories of medical errors and negligent behavior. They have presented a compelling counterargument.

On both sides of the discussion, there are basic assumptions that could be the basis for short-term or long-term projects. Here is the first – and perhaps biggest – question that could yield a fascinating answer. I'll look at more in my next post.

How many patients are harmed every year by medical errors? The patient advocates say:

Authoritative estimates of the number of malpractice deaths in the U.S. range from 100,000 to over 200,000 per year – the rough equivalent of a commercial airliner crashing every day. And the number of malpractice deaths is dwarfed by the number of people who are merely injured but not killed. Three respected studies in the past two years found that at least one in four hospital patients are harmed – that is almost nine million Americans each year.

As you might imagine, no federal government agency tracks deaths or injuries due to malpractice or medical error. (I make the distinction because the former has a legal weight and implies negligence.) The numbers above are estimates, and the range is wide.

That's one of the reasons so many reporters continue to cite the 1999 Institute of Medicine report "To Err Is Human," which said that "at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented, according to estimates from two major studies." Even if we take the lowest estimate and adjust roughly for population growth since 1999, that's a massive percentage of the annual number of deaths in the U.S. Consumers Union provided an update to the IOM report in 2009 with "To Err is Human –  To Delay is Deadly."

McGiffert wrote to me citing three studies, all done independently, that she says offer better estimates for the number of patients harmed by the health care system. Each report looked at all harm - not just serious harm and not just what sometimes is termed "preventable harm."

•               The Office of Inspector General of the Department of Health and Human Services, also using IHI's global trigger tool, found that 27% of Medicare hospital patients had been harmed by medical error.

•               Researchers using the Institute for Healthcare Improvement's "global trigger tool" found that 1 in 3 hospital patients had been harmed.

•               And a New England Journal of Medicine study in just one state, North Carolina, which has been looked to as a model in prevention of medical errors, found that 1 in 4 patients had been harmed.

McGiffert wrote:

No one is refuting these studies - they are solid. Also, I have a beef with only talking about deaths when so many millions more are harmed.  We KNOW the IOM is wrong because the deaths from hospital acquired infections ALONE are close to 100,000. So, I think it is time to stop repeating those tired and worn out estimates.

I agree. So let's try to add to the evidence base and find out the true number of patients both killed and harmed.