Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Thursday, May 29, 2014

Surgical mesh and medical destitution: a medical device failure.

26 May 2014
by Brittany Nunn

Photo by Hal Samples
Lakewood neighbor Aaron Horton just wants her mom back.
It’s the little things — like going out for sushi, window-shopping, getting facials or manicures, and chatting about art — that Horton misses the most.
“I miss my mom,” Horton says. “I miss being able to pick up the phone and say, ‘Hey, I just saw this purse and it made me think about you,’ or ‘I just saw this movie; let me tell you about it.’ ”
Although Horton’s mom is still alive, in many ways Horton has been forced to prematurely grieve the loss of the mother she once had.
Horton’s mom, who asked that we not reveal her identity, is in a constant state of excruciating pain — at times worse than anything she experienced during childbirth — due to an injury caused by a medical device called trans-vaginal mesh.
The pain wasn’t always so extreme.
Originally, Horton’s mother suffered from urinary incontinence (the loss of bladder control) and pelvic organ prolapse (a condition in which the bladder and the bowels slip out through the vaginal canal). To fix the problem, doctors used trans-vaginal mesh, which essentially is a small hammock made of plastic mesh, to hold her organs in place.
She was told the operation would be minimally invasive, but she knew something was wrong as soon as she woke up from the surgery. Her surgeon told her she simply needed time to heal.
The pain was localized at first, occurring only in her pelvic region, but it was unrelenting. For months, doctors dismissed the pain. Eventually it began to spread to every part of her body — sometimes it was sharp, sometimes it was dull, sometimes it was throbbing, and sometimes it was all three. She talked with more doctors, but no one could give her any answers. She tried physical therapy and nerve blocks, but nothing helped.
“My mom was really sick, and she wasn’t getting better,” Horton says.
“Once I realized how sick she was, I got online to see if there were other people, and I realized there’s this whole community of women who have been injured by this medical device.”
Horton wrote what she calls “a hearticle” about her experience of watching her mom suffer and not being able to help, and it was published on journalist Jane Akre’s website, Mesh Medical Device News Desk, in July 2013. Horton received an outpouring of support in the comments section.
“They had all gone through the same thing and had the same questions,” she explains. “I thought I was going to get some help, and then it just kind of confirmed that there was no help available.”
It spurred Horton to dig deeper, to find some answers for her mom, as well as for the many other suffering women.
She discovered that doctors have used medical mesh in more than 1.5 million women to fix organ prolapse, urinary incontinence or hernia, and they continue to implant it in some 70,000 to 90,000 women every year.
Most of the women are post-menopausal baby boomers who have had children.
Although many women are happy with the implant, thousands report suffering due to injury caused by the device.
Horton formed a nonprofit called The Mesh Warrior Foundation For the Injured, which she operates from her Lakewood home. She works full-time doing research, talking with doctors and surgeons, raising awareness about the mesh-related injuries, and advocating for the injured.
What Horton found during her research shocked her.
There are six manufacturers of the product, and the largest one is Johnson & Johnson, through the medical unit of its company, Ethicon.
Medical mesh is made of propylene plastic, and it was originally used for hernia repair. Then, in early 2000, manufacturers began creating other mesh products, which Horton says were never tested on live humans, only cadavers and dogs.
The U.S. Food and Drug Administration (FDA) approves the products through the 510(k) process, which “clears the device for commercial distribution” without having to go through the entire process, according to the FDA website.
Instead, manufacturers simply have to prove the new product is “at least as safe and effective” as a predicate device of substantial equivalence (SE) that has already been approved by the FDA.
As soon as the FDA rubber-stamps the device, manufacturers are free to start marketing it. Although there are other ways to fix medical issues such as incontinence or pelvic organ prolapse, most of the alternative methods are considered invasive, complicated and expensive. Mesh was marketed as simple and cheap, and the general public became the test subjects, Horton says.
The FDA in 2008 issued a Public Health Notification regarding “serious complications associated with trans-vaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.
The notice states, “The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”
“My question was: How did this happen to 1.5 million women?” Horton asks. “All the safeguards we have in our society, and we’re supposed to have the best health care in the world and the best access to it.”
Dr. Michael Hibner, the director of the division of surgery and pelvic pain at St. Joseph’s Hospital and Medical Center in Phoenix, has been removing the mesh from women’s bodies for several years.
“I think it’s a very small percentage [of women] that have a serious reaction,” he says. “There are people who are happy with the mesh. The problem is that those who are unhappy with it are really, really unhappy with it.”
Most of the women Hibner sees have pain due to three things: pain from the mesh rubbing against or tugging at the nerves, nerve damage during implant or explant of the mesh and/or a foreign-body reaction to the mesh itself.
Hibner believes manufacturers are largely to blame for the mesh-related injuries.
Hibner says that if the procedure is done right, women shouldn’t have pain or discomfort. The problem, Hibner says, is that manufacturers are selling the device to doctors as a one-size-fits-all device, and it’s being touted as a simple, non-invasive procedure, so the doctors implanting the mesh haven’t been appropriately prepared or trained.
Dr. Greg Vigna, who spent 18 years in the medial industry but now practices law in catastrophic injury in California, is familiar with the trail of broken lives mesh-related injuries leaves behind.
As a doctor, Vigna worked with patients who suffered from pudendal neuralgia, which is chronic pain due to the pudendal nerve, which is located in the pelvis, being entrapped or compressed. Until a few years ago, this was very uncommon.
“This mesh device caused a problem that used to be very rare,” he says. “It’s not rare anymore because mesh has been used so many times.”
Most women do not have the time, resources or the physical wellness needed to go head-to-head with pharmaceutical companies, so they become “medically destitute,” Vigna says. They lose their jobs because they can’t work, they lose their husbands because they can’t have sex, and they lose their families because they’re in so much pain they can’t function normally.
“There’s failure in the medical community, there’s failure in the financial community, and there’s failure in the legal community,” Vigna insists.
At the time of publication there had been 56,999 mesh-related lawsuits filed, according to Vigna, but very few settlements have come down.
At the same time doctors like Hibner are taking the mesh out, hundreds more continue to put it in. Other doctors try to remove mesh, but very few know how to do it correctly, Vigna says.
“For years women were only getting part of the mesh taken out, and that wasn’t helping,” Vigna says. “In fact, that was just making things more complicated for future doctors.”
Most of the women Hibner sees have already had the device extracted but are still experiencing pain, usually because parts of the mesh are still inside the body, pulling at sensitive nerves. He says he believes removing the entire device, all at once, is best.
“I’ve seen women who have clearly gotten better after removing the mesh. But then, there are other ones who didn’t. So I think it depends on the patient. Some have had more injury to the nerves, and others have had less injury to the nerves, so it’s hard to tell.”
Horton and her family are crossing their fingers, hoping Horton’s mother is one of the lucky ones.
Horton’s mother had surgery to have her mesh removed in May, and her family is still waiting to find out if the surgery was successful in lessening or erasing her pain.
“But the truth is, each injury is different,” Horton says. “They don’t know what happens during the explant because it just depends on the woman’s body and the kind of injury.”
In the meantime, Horton continues to research and fill her blog with personal stories and interviews with doctors in hopes of reaching as many women as possible.
“There’s still so many more who don’t know,” Horton says. “That’s what keeps me awake at night.”
To learn more  about Aaron Horton and The Mesh Warrior, visit

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Comment - FiDA  (retrieve this)
Thank you for this excellent article, Brittany Nunn and Lakewood/East Dallas Advocate!  My advocacy to demand safer and more effective implanted medical devices began 5 years ago when a family member began suffering with a failed implanted device.  What I learned chills me to the bone in the middle of a Dallas summer:  the system is rigged!  Medical device companies have so much clout that our FDA is a mere mirage and there is no "there" there.  Patients are not protected and even the judicial system has been altered to favor the industry and protect the profiteers from accountability.  The mounting patient harm signals "settlements" that do little to stop the carnage.  I blog at Failed Implant Device Alliance and attended FDA Patient Representative training (by invitation).

Friday, May 23, 2014

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

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.

Thursday, May 15, 2014

Mounting Patient Harm and FDA history of medical device disasters!

Posted on May 13, 2014 by FDA Voice  FiDA highlight
By: John Swann, Ph.D.
Looming sentry-like over the collection of artifacts that document FDA’s  history, the products  we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules.  This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.
Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short.  FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes.
Much of the collection captures the problems that gave rise to the laws and regulations we have today, a regulatory arc often originating with a problem product—sometimes of disastrous proportions. Thus one can find specimens of:
                Elixir Sulfanilamide, a poisonous preparation of a wonder drug in 1937;
                thalidomide,  the globally marketed sedative that caused thousands of grave birth defects in the 1950s and 1960s;
                Bon Vivant vichyssoise, a botulism threat in the early 1970s;
                the ill-designed Dalkon Shield intrauterine device that caused thousands of pelvic infections; and
                ephedra-containing dietary supplements from the 1990s that killed several users.
These are among the objects that eerily illustrate why we have the laws and regulations we do.
Decision-making in the agency depends to a considerable extent on investigations and analyses, some of the tools of which are documented here. These artifacts of the growth of regulatory science include:
                balances and early calculating devices used in the laboratories of the Bureau of Chemistry from the 1900s to 1920s to analyze questionable foods and drugs;
                triers, tools used for routine sampling of various foods to ensure compliance with the law, from the mid-20th century; and
                advanced analytical devices from the 2000s to detect sophisticated counterfeiting of medicinal products.

Treatments of dubious value for both serious and non-serious diseases make up a significant part of the collection as well. There are hundreds of fraudulent medications, primarily up to about World War II, as well as hundreds of medical devices from the 1950s and 1960s that offered hope with no scientific underpinning.
In addition, how the public came to engage FDA and its work, especially from the 1970s forward, can be seen in a number of objects, including protest buttons and placards from the past two decades.
Artifacts like these tell the story of how our many laws and regulations came to be, how FDA has carried them out, and how the public and FDA have engaged each other in the interest of the public health.

John Swann, Ph.D., is an Historian at FDA

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Wednesday, May 14, 2014

If my knees were a car, my mechanic would choose my next automobile!

Jim Landers

Published: 12 May 2014 09:15 PM
Updated: 12 May 2014 09:44 PM  FiDA highlight

WASHINGTON — This winter, I had my knees replaced. I used a surgeon and a hospital in my neighborhood of Alexandria, Va., not far from where I work. The surgery and rehab are going fine. The lessons in health care economics are becoming strange.
For each knee, the bills (hospital, surgeon, anesthesiologist) came to roughly $32,000. Michael Toomey, president of Compass Care Engineering in Dallas, says the average in the Dallas area is between $42,000 and $43,000.
My new mechanical knees were the most expensive items in the bills. The hospital wanted $16,097.05 for each of them. My insurance agreed to pay $10,982.72 apiece.
These are Sigma System knees, size 5, made by DePuy Orthopaedics of Warsaw, Ind. DePuy is part of Johnson & Johnson.
The knees are made of cobalt, chrome and polyethylene. There’s a buckle-like piece that fits over the knee tip of my thigh bone. There’s a piece that looks like a peg with a circle on it drilled into my shin bone. Between them is a plastic disc. On the back of the knee cap, there’s a metal dome.
My surgeon chose these knees. The hospital bought them. Insurance (and my out-of-pocket max of $3,000) paid for them.
So, let’s see, if my knees were a car, my mechanic would choose my next automobile. A garage would buy it, and add its own markup. My employer (which is where I get health insurance) would pay for most of it, using an insurance administrator to bargain over the price.
Survey of surgeons
This is standard practice in the medical world. Device manufacturers will pitch their products to surgeons, but the surgeons are often in the dark or heedless of the cost. A survey cited in the January issue of Health Affairs found that 81 percent of orthopedic surgeons could not accurately guess the cost of these devices. And American surgeons replace about 720,000 knees a year.
Baylor Scott & White Health is using a different approach. The surgeons and the supply people meet to talk openly about prices and quality. They agree on a price the hospital system will pay. Medical device makers are then invited to meet or beat that price.
“Everybody can play, but you have to meet this capitated [maximum] price,” said Pam Bryant, Baylor Scott & White’s senior vice president for supply chain services.
Surgeons can choose among four or five key types, Bryant said.
Texas Health Resources also negotiates as a chain for its joint replacements. But here, the surgeons can choose what they like.
“While there is a great deal of similarity between devices, surgeons have definite preferences based upon training and their individual style of surgery — as well as the individual patient needs, including age, activity and other factors,” said John Gaida, THR’s senior vice president for supply chain management.
“Texas Health strives to make virtually all brands of hip and knee implants available to our surgeons so that the patient needs are always the primary consideration,” he said.
Across the country, surgeons are not clued in on the cost of medical devices often because the hospital can’t share that information. They typically sign a contract with the medical device company that forbids disclosure.
Doctors order
I know little about mechanical knees. My surgeon implants them all the time, so it makes sense to follow his guidance on what would suit me best and last longest.
But we didn’t go over a list of knees and manufacturers. My surgeon asked about my lifestyle, looked at my age and weight, and chose for me.
The hospital did the negotiating with DePuy. Did they get a good deal?
A 2012 Government Accountability Office report covering a small sample of hospitals found that one paid $5,200 for a knee replacement while another paid $9,500 for the same device.
There are several types of knees on the market. There’s a standard, fixed-bearing knee; a rotational knee that can handle more twists and turns; and a rotational/full flexion knee that allows for deep squats.
Prices seem to run between $2,000 and $16,000 for the device. So it turns out that my new knees (rotational) are pretty high-end. I hope they last a long time.

Follow Jim Landers on Twitter at @landersjim.

Monday, May 5, 2014

San Antonio, TX: Women harmed by implanted surgical mesh

by Deborah Knapp / KENS 5

Posted on May 1, 2014 at 9:52 PM
 Follow link above to watch the video.  FiDA highlight

SAN ANTONIO -- More than 20 million women in the United States have urinary incontinence.  Yet, the topic is often taboo.
A device that was supposed to help the condition is now at the center of thousands of lawsuits from women who say it's ruined their lives.
Jennifer Ramirez is one of those women who says she is in constant pain after receiving a mesh implant that was supposed to cure incontinence.
In Ramirez's case, she didn't even have a serious condition, it was used to prevent it from developing further.
"I have pelvic pain, constant pelvic pain," said Ramirez.
 Life is also painful for 64-year-old Linda Batiste.
The condition that brings both women to tears is embarrassing to discuss.
"It actually does feel like a scouring pad in your body.  You can feel in your women parts, what it is.  It's there," said Batiste.
That feeling comes from a product left inside her body to fix urinary incontinence.
In thousands of cases, including Batiste and Ramirez, doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.
But, what the women got was not relief.
"I have never been pain-free, since then," said Batiste.
After the birth of her third child, Ramirez underwent a hysterectomy and then got the mesh sling.
"I had it as a precautionary when I had my hysterectomy because I had some stress incontinence from coughing or sneezing or jumping on a trampoline," said Ramirez.
The pain forced her to have the device removed just months later. 
"Now my life has to revolve around having a restroom right there because when you have to go you have to go or you will have an accident. It's embarrassing and depressing," said Ramirez.
Other complications from mesh implants develop when it becomes embedded in organs and it can make sexual intimacy painful.
"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes and it has particle loss.  And all of those problems cause other problems. like scarring, chronic pain, for example," said Tim Goss who represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon.
Surgical mesh is a synthetic material. 
It's manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse and hernia operations. 
The American Urogynecologic Society said it's "safe, effective, and has improved the quality of life for millions."
The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices"
In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare."  and that mesh "may expose patients to greater risk" than traditional procedures.
Since then, women across the country have formed organizations and online support groups, trying to get mesh removed from the market.
Linda Batiste just won a $1.2 million verdict against the maker of her mesh in the first case of its kind in the nation to go before a jury.
"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product," said Goss.
Goss, who represents 9,000 mesh cases himself including Jennifer Ramirez's, says the lawsuits have the potential to become the largest mass-tort in history, bigger - even - than the phen-fen diet drug mess.
Linda Batiste has had several surgeries to try to removed the mesh, which is embedded in her tissue.
And, her original problem of incontinence is back.
"And it's compounded the pain that I normally would have had.  I never wish for any other woman to feel this way or to have it happen to them, " said Batiste.
Tuesday, the FDA announced it wants stricter safety rules for the mesh implants.
It is proposing labeling the female incontinence device as "high risk"  after years of reports of pain among women who have received the implants.
Right now there are more than 100,000 cases in the U.S. pending against the makers of the mesh. 

The attorney we spoke to said since the mesh implants are still being used, he expects that number to increase.