Showing posts with label patient outcome research. Show all posts
Showing posts with label patient outcome research. Show all posts
Monday, November 20, 2017
Thursday, November 9, 2017
All the Patient Outcome Information the Hip Surgeons Want You to Know . . . M/M failures mentioned???
Written by Laura Dyrda | Friday, 03 November 2017 17:06
The American Joint Replacement Registry released its 2017 Annual Report, outlining data on hip and knee replacements.
The report, released at the 2017 American Association of Hip and Knee Surgeons Annual Meeting in Dallas, Nov. 2 to Nov. 5, includes data from 654 institutions and 4,755 surgeons who performed 860,080 hip and knee replacements.
"The AJRR has seen significant growth since the previous report; this year's report has a 101 percent increase in procedures, a 57 percent increase in reporting institutions and a 50 percent increase in surgeons," said AJRR Board of Directors Chairman Daniel Berry, MD. The data includes primarily procedures performed in the hospital, although eight ASCs reported data for 1,020 procedures.
Key highlights from the report include:
1. Hip revision surgery burden: 8.6 percent (down from 14.6 percent in 2012)
2. Knee revision burden: 5.1 percent (down from 6.2 percent in 2012)
3. Primary knee implant design:
• Posterior stabilized: 48.5 percent
• Cruciate retaining: 35.3 percent
• Ultracongruent: 5.6 percent
• Other: 8 percent
4. Unicompartmental knee replacements: 3.2 percent of all primary knee replacements
5. Surgeons performing unicompartmental knee replacement: 24.3 percent
6. Surgeons performing patellofemoral arthroplasty: 4.7 percent
7. Average length of stay for primary hip replacements: 3.5 days
8. Average length of stay for primary knee replacements: 2.9 days
https://www.beckersspine.com/orthopedic-spine-practices-improving-profits/item/38792-8-key-trends-on-hip-and-knee-replacement-surgeries.html
Tuesday, May 2, 2017
Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?
April 28, 2017 FiDA highlight
Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.
But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.
“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.
“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”
"I had necrotic flesh in there." (Image supplied)
"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."
From there, Kim's condition spiralled.
"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."
Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".
"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."
The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.
The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".
By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.
By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.
Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".
While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.
The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.
"I felt like I was rotting from the inside," she describes.
By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.
The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.
"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.
"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."
The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.
Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.
To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.
There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)
While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.
"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."
Kim also lives with a level of anxiety she likens to post traumatic stress disorder.
"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."
If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.
When Kim found someone who had experienced what she had online, she was overwhelmed.
"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.
"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."
"I want everyone to know about it." (Image supplied)
Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".
It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.
Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.
But the aim is to do more than just have the mesh banned - it's to get justice.
"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."
And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.
If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state:
Victoria; New South Wales/ACT; Queensland; South Australia; Western Australia; Tasmania; Northern Territory.
http://www.mamamia.com.au/transvaginal-mesh-implants/
Tuesday, November 22, 2016
Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes
Bayer’s Essure Contraceptive Implant, Now With a Warning
By RONI CARYN RABIN NOVEMBER 21, 201
Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.
The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.
Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.
Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.
EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES
“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”
Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.
Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.
F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.
The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.
Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.
“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.
The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.
The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.
Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.
“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.
Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.
The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”
Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.
The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.
Many doctors who insert the implant do not know how to remove it.
By contrast, drug trials are required to have a comparison group of participants who are given a placebo.
Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.
This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.
The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.
Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.
http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F
Monday, October 31, 2016
Patient Outcomes Research Rejected at Harvard/Mass General 100 Years Ago
DAVID L. RYAN/GLOBE STAFF
Dr. Ernest Amory Codman told his wife before he died in 1940 not to spend money on a headstone. Dr. Andrew Warshaw spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.
By Liz Kowalczyk GLOBE STAFF JULY 21, 2014
Dr. Ernest Amory Codman was in his mid-40s when his golden career as a sought-after Harvard surgeon began to unravel. He had quit in exasperation from Massachusetts General Hospital, and when he took his dispute with hospital leaders public, colleagues turned against him. Many stopped sending him patients.
MASSACHUSETTS GENERAL HOSPITAL ARCHIVES
Dr. Ernest Amory Codman.
It was the early 1900s, and Codman was impatiently pushing hospitals and doctors to adopt a practice many considered heretical at the time: Record the “end results’’ for every patient — including harm caused by physicians’ errors — and make them public.
A century later, many of Codman’s ideas are the bedrock of modern medicine. And a group of doctors, including a former Mass. General surgery chief, plans to make sure he gets the wider appreciation he deserves this week.
Codman’s ashes are buried in his wife’s family plot in Mount Auburn Cemetery in Cambridge, with no personal marker. Dr. Andrew Warshaw, the hospital’s chief of surgery from 1997 to 2011, has spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.
The headstone is “an overdue homage” to Codman and the ideas he pushed at Mass. General and nationally, Warshaw said. “His senior doctors couldn’t be bothered. They said it wasn’t necessary. Of course, people were threatened.’’
Even after Mass. General began tracking some outcomes, making that information public was anathema. “The general executive committee does not consider it advisable,’’ Dr. Joseph Howland, the hospital’s assistant administrator, cryptically wrote Codman in April 1914.
Codman himself lived his beliefs with excruciating honesty.
“I made an error of skill of the most gross character and even failed to recognize that I had made it,’’ he wrote in a published report after a woman died following a gallbladder operation in 1917.
These days, there is little escaping Codman’s notions, as everyone from patient safety groups to President Obama pushes for measurable quality and transparency in medical care.
Codman’s close examination of patient cases led to weekly meetings now held at Mass. General and many other hospitals called “morbidity and mortality’’ conferences, and his insistence on “hospital standards’’ eventually prompted the formation in 1951 of the Joint Commission, a national organization that evaluates hospitals.
“He deserves to be much better recognized,’’ said Dr. William Mallon, a shoulder surgeon who wrote a comprehensive biography of Codman that was published in 1999.
But it was not until another Harvard physician, Dr. Lucian Leape, started publishing studies on the frequency of medical errors in the 1990s that the profession and government began to intently examine the issue.
And it has been only in the past 10 years that regulators, patient safety experts, and some doctors have advocated for making outcomes and errors public, as a way to further encourage improvement. As Mallon pointed out, however, few physicians are as open as Codman about their mistakes, in part because of the threat of lawsuits, and mortality and morbidity conferences remain highly confidential.
Dr. Lamar McGinnis, a cancer surgeon from Georgia who has researched Codman’s career, said it was not only his ideas, but his abrasive personality that hurt him professionally. “He was really stepping on toes,” McGinnis said.
‘He deserves to be much better recognized.’
Frustrated with Mass. General’s refusal to fully embrace his ideas, Codman left his full-time job there in 1911 to start his own 12-bed hospital in a Beacon Hill brownstone. He required his doctors to report their results and he tracked his own patients on hundreds of 3 x 5 cards. He advertised the “Medical Ethics of the Codman Hospital’’ — a mission statement of sorts that stated “large fees are only justifiable’’ when a surgeon’s skills have been proven.
Codman continued to pursue changes at Mass. General, and while the hospital began to track patient outcomes, it stopped short of investigating the reasons for poor results, according to letters Codman wrote to hospital administrators. He warned that his ideas were gaining traction in Philadelphia, threatening Mass. General’s position as a national leader.
“It is really easier to overturn a whole city than it is to wake up the trustees of Massachusetts General Hospital,’’ he said in a letter in March 1914, the month he cut ties completely with the hospital to protest the seniority system. Codman urged Mass. General to “do some house-cleaning’’ and stop promoting doctors because of their reputations instead of advancing those with good results.
Codman’s surgical career took a dive in January 1915, when he organized a meeting on hospital standards as chairman of the Suffolk District Surgical Society. Before dozens of colleagues, Codman unveiled a cartoon he had asked a friend to draw.
An ostrich with its head buried in the sand kicked out golden eggs to Back Bay doctors. The heads of Mass. General watched, scratching their heads and asking, “If we let her know the truth about our patients, do you suppose she would still be willing to lay?’’
The audience was aghast, Codman later wrote. He was told to resign as chairman of the group, and as referrals plummeted that year, so did his income — to $5,000 from $8,000 the prior year. He closed his hospital to help treat the injured after two army munitions ships collided and exploded in Halifax, Nova Scotia, in December 1917.
MASSACHUSETTS GENERAL HOSPITAL ARCHIVES
Dr. Ernest Amory Codman shocked colleagues with a cartoon critical of Back Bay doctors.
Still, Codman was hard to ignore back in Boston. He became an expert in shoulder surgery and bone sarcoma, and Mass. General reinstated him as a consultant in 1929. By the time he died in 1940 at his home in Ponkapoag, now Canton, the wounds appeared healed.
Two weeks after his death, trustees at Mass. General, which had begun to adopt his ideas, passed a resolution calling him a “champion of truth’’ who was “willing to sacrifice personal place and standing to achieve what he believed to be right.’’
Codman never recovered financially after his surgery practice dwindled, according to his biographer, and he told his wife before he died of melanoma in 1940 not to spend money on a headstone.
The memorial project took far longer than Warshaw expected.
Codman and his wife, Katherine Putnam Bowditch, did not have children, and doctors were unable to find a relative to give permission for the headstone. So Warshaw contacted Mount Auburn, which began researching the expansive cemetery plot, purchased by the prominent Bowditch family in 1845. Nathaniel Bowditch, Katherine’s great-grandfather and a ship’s captain from Salem, was a pioneer of modern maritime navigation.
Mount Auburn determined that it controlled a portion of the plot, and gave Warshaw permission to move forward with a memorial. Warshaw, who will become president of the American College of Surgeons in October, plans to make Codman’s accomplishments the theme of his opening speech in San Francisco.
A small private ceremony will be held at his gravesite on Tuesday. The memorial, which describes Codman as the “father of outcomes assessment and quality measurement in health care,’’ sits under a shady stand of eight Canadian hemlocks, just behind Nathaniel Bowditch’s grave.
Inscribed under Codman’s name and portrait in bronze are these words: “It may take a hundred years for my ideas to be accepted.’’
Liz Kowalczyk can be reached at kowalczyk@globe.com
Tuesday, June 14, 2016
Zimmer Persona Knee Revision Surgery Prompts Recall
Zimmer Persona Knee: They Don’t Make ’em Like They Used To
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June 13, 2016, 08:00:00AM. By Gordon Gibb FiDA highlight
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Warsaw, IN
It’s a common refrain in the modern age: things are not as they were. People don’t respect each other, or each other’s property like they used to. The politeness of old has vanished. “They don’t make ’em like they used to.” And for the most part, things aren’t built to last. One must forgive such a lament coming from the plaintiff behind a Zimmer Persona lawsuit alleging a failed Zimmer Persona Trabecular Metal Tibial plate.
Pundits find it remarkable that while the life expectancy of Americans continues to rise - thanks in part to ongoing advancements in modern medicine, disease prevention and more active lifestyles - the quality of the “parts” employed to make us whole again continues to decline, or so it appears.
A fast-track approval process employed by the US Food and Drug Administration (FDA) to bring new products to market more quickly without the traditional, years-long clinical trial process isn’t helping.
There is little doubt that for the majority of Americans, prosthetic knee devices work well and are on track to achieve the assumed service life expectancy of 15 years or more. However, when patients begin having problems with their medical devices - again, in the minority - even an apparent small number can have sufficient statistical impact to warrant a product recall.
That’s what happened last year with the Zimmer Persona Trabecular Metal Tibial plate. The latter is a plate that sits atop the tibia and serves as the surface area for the prosthetic knee device. According to various attorneys engaged in Zimmer lawsuits, a growing minority of patients reported loosening of the plates. This, in part, appears to be exacerbated by a lack of bone growth into the tibial plate, which would serve to anchor the plate. For a statistically large number of patients, this bone growth was either insufficient or not happening at all, leading to Zimmer Persona Knee pain and failure of the artificial knee.
Just referencing the failure of a medical device, implanted into a human body and failing soon after implantation, is serious enough without consideration of where a patient might be, or the activity involved at the point at which an artificial knee fails: driving a car; crossing a busy intersection; skiing; even walking across the kitchen with a steaming hot cup of tea from which a patient could suffer scalds or serious burns were a Zimmer knee to suddenly fail.
Thus, the Zimmer Persona Recall of 2015 when the Zimmer Persona Trabecular Metal Tibial plate was voluntarily recalled by the manufacturer - a recall endorsed by the FDA. Many patients experiencing Zimmer Persona Knee pain from a failed Zimmer Persona Trabecular Metal Tibial plate and requiring revision surgery to replace the failed component(s) are filing a Zimmer Persona Metal Plate lawsuit to seek compensation for pain, suffering and even loss of income. Revision procedures are often more complex than the initial procedure, with higher rates of complication. Having to go through a second surgery so soon after the first, followed by additional rounds of physiotherapy and rehabilitation, can eat into an individual’s income and livelihood given the additional time away from work.
The Zimmer Persona Trabecular Metal Tibial plate, it should be noted, was brought to market through an FDA 510(k) Clearance, the regulator’s fast-track program that allows design updates or new devices substantially similar to those already on the market and performing well to be brought to market without having to go through a clinical trial.
Clinical trials are long-term tests on volunteer patients, conducted to establish the safety and efficacy of a medical device before it is released to market and made available to the general population. If there are problems that surface in clinical trials, the device can be revised prior to a full market release.
Zimmer Biomet (Zimmer) is not the only manufacturer recalling medical devices. Other blue-chip medical devices firms are becoming saddled with recalls. Similarly, the FDA 510(k) Clearance is available to most large device manufacturers.
Speaking of Zimmer, US Official News (4/14/16) reports another Zimmer Persona Recall, but this one has to do with packaging. According to the FDA, the recall involved the Persona Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty (REF # 42-5114-008-18).
The recall stemmed from a complaint that there were two sets of information on the box containing the product: One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
The products at issue were distributed to various states in the United States as well as globally (but not Canada).
The Zimmer Persona Recall was voluntary, issued by the manufacturer.
https://www.lawyersandsettlements.com/articles/zimmer-persona/zimmer-persona-lawsuit-recall-10-21533.html?opt=b&utm_expid=3607522-13.DLfjpNTnSeOVrAk1Ud2uNA.1&utm_referrer=https%3A%2F%2Fwww.facebook.com%2F
Monday, January 4, 2016
Pelvic Surgical Mesh Regulation: Too Little, Too Late!
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
For Immediate Release
January 4, 2016
FiDA highlight & comment
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. *
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.
Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months,(June 2018) as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.
Doctors may perform surgery on women with POP who have significant symptoms, often using a minimally invasive transvaginal technique to reduce recuperation time. Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP, but over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:
- Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
- Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
- Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP; and
- Issued two proposed orders in May 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a PMA application.
Manufacturers may choose to submit a PMA before the 30-month deadline.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Study: 50% Harmed Women Have Complete Recovery When Bayer Essure Coils Removed
Results of National Center for Health Research study of 1104 women with Essure problems
2015 FiDA highlight
86% reported pain (mostly pelvic or abdominal)
34% reported excessive bleeding – some bled every day of the month instead of a regular period
22% fatigue
16% hair loss
12% hysterectomy
12% depression
7% allergy
These are all women reporting serious complications, not a random sample of Essure patients.
About 35% had Essure removed and about half of those had a complete recovery. Only 5% of those who had them removed reported no improvement in symptoms.
http://bit.ly/1PHkokA
Monday, August 17, 2015
Sacrificial lambs! U.S. Senate: AMEND 21st Century Cures Act
- OpEd by
- A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices?
I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use.
In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits.
When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
Just look at the morcellation debacle. A device intended to grind tissue into little pieces, thus allowing hysterectomies to be performed through a small incision, was found after 20 years of use to be spreading cancer. High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.
That's right, untold numbers. No one in the United States is effectively watching what happens to these devices after they are implanted in patients. The safety feedback loop, which helps spur device improvement and safeguards patients, is all but lacking.
The problems with metal-on-metal hip implants were first systematically detected in England, which has an effective reporting registry.
Problems with retrograde medical endoscopes spreading untreatable bacteria were known in Europe two years before the United States, and morcellators posed an unacceptable risk of spreading cancer for many years before anyone noticed.
Some have stated it is not practical to test all medical devices. This may be true, but I want any device implanted in me to be thoroughly tested.
The U.S. House of Representatives passed the 21st Century Cures Act but instead of strengthening medical device oversight, the House weakened the requirements for testing even further.
What are patients to do?
First, remember that for many implants the benefits are overestimated and the risks underestimated. Before any implant procedure patients should at least ask:
■ What is the implant's failure rate?
■ How does the tissue react around the implant?
■ If the implant fails can it be taken out?
I was faced with a decision once to have metal cervical joints placed at multiple levels in my neck. I asked the above three questions. The first two were not known and the answer to the third was no. I chose to have the "old-fashioned" cervical fusion.
Some would think that a device that has long been in use would be safe. But, as exemplified by the morcellator, which was first marketed in 1994, if no one monitors for problems they may be perpetuated indefinitely. Out of sight, out of mind.
Next, patients should check the MRSA and C. Difficile rates at their hospital, available on Hospital Compare (https://www.medicare.gov/hospitalcompare/).
If you are having a hip or knee implant or a lumbar or cervical spine fusion, check for your surgeon's complication rates on ProPublica's Surgeon Scorecare website(https://projects.propublica.org/surgeons/).
Finally, remember nothing lasts forever and all man-made devices can fail, so keep your follow-up appointments.
For those with chrome-cobalt metal hip implants, consider having blood cobalt levels tested to screen for dangerous, and sometimes life-threatening, heavy metal poisoning. Your doctor may tell you there is not good literature to support the testing. But remember few are looking for or monitoring problems.
Dr. Stephen Tower just reported in the Journal of Patient Safety 25 cases of cobalt poisoning from hip implants. Until the true incidence is known, play it safe and get tested.
According to a report from Johns Hopkins published in the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. It is more likely than not that you are or will be an implant recipient.
Almost everyone has a stake in health-care policy regarding implants.
We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.
Dr. Kevin Kavanagh of Somerset is board chairman of Health Watch USA.
My comment: I trained 9/2010 at FDA/CDRH as a Patient Representative. In 2008 my brother was implanted with a Tornier elbow that was designed by the Mayo Clinic surgeon that performed the implant. The elbow failed(pain and loss of function) and was 'revised' by removing two of the components . . . yet it was not reported to the FDA as an adverse event. Multidistrict lawsuits (MDL's) for metal-on-metal hips(100,000) and pelvic surgical mesh(75,000) have begun to prompt anemic settlements for the PREVENTABLY, severely and permanently harmed patients. Implanted elbows are rare (@4,000 annually) and can be considered an 'orphan' device and lawyers have little incentive to bring a lawsuit. The surgeon is not legally required to report an AE (adverse event) unless there is a fatality and the FDA does not investigate anyway. If patients knew the catastrophic downside and actual patient outcome statistics on implants they would demand the medical device implant industry provide a product warranty on permanent implants. Marketing statements should align with patient outcomes. The 21st Century Cures Act is an affront to public health and all the SACRIFICIAL LAMBS that Dr. Kavanagh refers to.
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