USA Patient Network-Advanced Patient Training Workshop June 3-4, 2016

I (Joleen Chambers) attended this excellent workshop last weekend (photo above).  Every patient should have this information BEFORE taking any drug or being treated with any medical device!  Dr. Diana Zuckerman, President of the National Center for Health Research hosted the workshop and these are her presentation slides.  I also must thank PCORI (Patient Centered Outcomes Research Institute) for awarding partial financial support to the host organization of this workshop.  

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FDA has a 'hearing problem'. Harmed patients (women) amplify social media voice!

FDA Reviews Essure to See if Device Causes Problems by REUTERS  9/23, 2015

U.S. health experts will review the potential risks of Bayer AG's permanent contraceptive device, Essure, on Thursday in light of growing complaints over possible side effects, and consider whether its use should be restricted. Some 17,000 women who had the device implanted and claim it has hurt them are members of the Facebook group "Essure Problems," run by Angela Lynch, who herself experienced problems with Essure. Complaints voiced by the women include chronic pain, heavy bleeding, fatigue and skin allergies. The Food and Drug Administration panel will be asked to discuss potential changes to the product's label and whether further clinical studies should be conducted. The panel will not be asked to formally vote on their recommendations. Bayer obtained the device with its $1.1 billion acquisition of Conceptus in 2013 and maintains it is safe and effective. It says roughly 750,000 units have been sold, mostly in the United States. It's a small metal spring that goes into the fallopian tubes - an alternative to tying them. Dr. Patricia Carney, the company's medical director for Essure, said the company welcomes the discussion. "We want to understand as a company what is going on," she said. "We want to know whether there is a link to the product." Already the complaints have led some physicians to re-examine their use of the device. Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, was an early European adopter, implanting the device in nearly 1,400 women and training dozens of practitioners in its use. He now believes more research needs to be done to establish what, if any, relationship exists between the device and the problems relayed by some patients. "If there is something wrong with the device I want to know," he said. Veersema said a stronger screening process might be warranted to avoid implanting Essure in women who already have a uterine problem, such as fibroids. Angela Lynch was 28 when she was implanted with the device. She had three children and did not want any more. "Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust," she said. "After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting." In 2012 she had the device removed and underwent a hysterectomy. "After three days it was like I woke up from a five-year flu," she said. Dr. Cindy Basinski, who consults for Bayer and will be testifying on the company's behalf at the FDA meeting, has been implanting the device since 2006 and has conducted about 1,100 procedures with minimal complications. She has had "a couple" of patients come to her with complaints and one asked for the device to be removed. Basinski, who practices in Newburgh, Indiana, said she in "no way discounts the patients out there recounting their experience," but said it was not possible to draw scientific conclusions from anecdotal information. For some doctors, it is not just the implantation of the device that needs to be looked at but how it is removed. Dr. Shawn Tassone, who practices at a clinic in Austin, Texas, began implanting Essure in 2008, said there is no standardized method for removal. "I'm hoping that all this will change the way doctors counsel their patients," Tassone said. "Instead of saying Essure is an easy procedure with no side effects, (they should) say this is a surgery and there are people reporting complications."

http://www.nbcnews.com/health/womens-health/fda-reviews-essure-see-if-device-causes-problems-n432351

FDA, Medical Device Industry Profit and Harmed Women Collide With Pope Francis in DC on September 24

Essure complaints spike nearly 1,400% in 3 years

SEPTEMBER 22, 2015 BY BRAD PERRIELLO 

The FDA logged a nearly 1,400% spike in complaints filed over the Essure permanent female sterilization treatment made by Bayer (ETR:BAYN), according to a review released yesterday ahead of an FDA advisory panel meeting this week.

Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002.

In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking. Those adverse event reports include 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons such as infection and uterine perforation, the FDA said.

There were 152 complaints filed in the FDA’s Manufacturer & User Facility Device Experience database in 2012; last year there were 2,259 complaints filed in the MAUDE database, a 1,386% increase. So far this year there have been 1,363 MAUDE complaints filed with the FDA, the agency said. The FDA cautioned that the complaints it received had limitations such as incomplete or inaccurate data and did not necessarily directly indicate a faulty or defective device.

The FDA’s Obstetrics and Gynecology Devices advisory panel is set to meet Sept. 24 to discuss the risks and benefits of Essure and has invited feedback from presenters, panel members and the public. Some 17,000 women who had the device implanted and claim it has hurt them are members of the Facebook group “Essure Problems,” run by Angela Lynch, who herself experienced problems with Essure. Complaints voiced by the women include chronic pain, heavy bleeding, fatigue and skin allergies.

Lynch, who was 28 when she was implanted with the device, had 3 children and did not want any more.

“Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust,” she said. “After 2 years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.”

In 2012 she had the device removed and underwent a hysterectomy.

“After 3 days it was like I woke up from a 5-year flu,” she said.

In May, Bayer cited a 364-patient 5-year study of the device published in the Journal of Minimally Invasive Gynecology that indicated no pregnancies after 5 years and that the Essure inserts were “generally well tolerated.” Pelvic pain was reported in no more than 7% of patients, but no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits, according to Bayer.

The study reported 3 serious adverse events “possibly related” to Essure in the trial, including irregular menstrual bleeding, lower abdominal pain and heavy periods and continuous bleeding. The latter 2 patients ended up having hysterectomies.

Dr. Patricia Carney, the company’s medical director for Essure, said Bayer welcomes the discussion. “We want to understand as a company what is going on,” she said. “We want to know whether there is a link to the product.”

In February a citizens petition lodged with the FDA asked the safety regulator to take Essure off the U.S. market, alleging that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.

In July, the FDA approved using transvaginal ultrasound as an alternate test to confirm if the Essure implant has been placed properly. A month later Bayer cut the ribbon on a new plant in Costa Rica where it plans to make Essure.

Material from Reuters was used in this report.

http://www.massdevice.com/essure-complaints-spike-nearly-1400-in-3-years/

Proto-AE: FDA Monitors Social Media

FDA panel set to vet Essure safety

By: M. ALEXANDER OTTO, Ob.Gyn. News Digital Network SEPTEMBER 22, 2015

On Sept. 24, the Food and Drug Administration’s Obstetrics and Gynecology Devices Panel will meet in Silver Spring, Md., to discuss the future of Bayer’s Essure permanent female sterilization coil.

FDA officials have asked the 19-member advisory panel to evaluate the currently available scientific data on the safety and effectiveness of the Essure system and make recommendations on appropriate use, product labeling, and the potential need for additional postmarket clinical studies.

Since Essure’s approval in 2002, the FDA has received more than 5,000 complaints about Essure. Most concern chronic pain, perforation, dyspareunia, device migration, menstrual problems, and possible allergic reactions to the nickel in Essure, but more than 100 adverse symptoms have been reported to the agency, according to newly posted meeting materials.

The complaints have been filed mostly in the past 2 years by patients who have organized online to share their stories and lobby to have Essure taken off the market; some are involved in legal action against Bayer. Meanwhile, Bayer maintains that, for most of the approximately 750,000 women who have received Essure, the device is safe and effective.

Advisory panel members will have their work cut out for them as they sort through the issues. The FDA has released a new 89-page review of Essure, and Bayer has submitted its own lengthy review document. Testimony is expected from Bayer, FDA reviewers, patients, and others. The meeting is scheduled to run almost 12 hours, from 8 a.m. to 7:30 p.m. Eastern time, at the agency’s White Oak Campus in Silver Spring, Md., and will be broadcast live online.

FDA noted in its review that it has been monitoring social media with automated software that scours Twitter, Facebook, patient forums, and other websites for “posts with resemblance to adverse events” or “Proto-AEs.” The program picked up 350,000 references to Essure between September 2013 and July 2015 and classified more than 20,000 as Proto-AEs, mostly related to pain, hysterectomy, malaise, pregnancy, and device removal. The social media data, however, are preliminary since the FDA has yet to remove duplications and retweets.

aotto@frontlinemedcom.com

http://www.obgynnews.com/index.php?id=11192&tx_ttnews%5Btt_news%5D=436145&cHash=e624afa2524b5dffe9ae6f48474e9351

Joint Replacement Patient Outcomes Registry: Proprietary!

Functional Outcomes Data for Joint Replacement Ups the Quality Ante

Cheryl Clark, for HealthLeaders Media , April 2, 2015  FiDA highlight added

Collected by an evolving roster of state registries, functional outcomes data complements data on readmissions and complications and is of value to surgeons, hospitals, and payers as well as to prospective patients.

As Medicare and state agencies increasingly turn their scrutiny to complication and readmission rates for the more than 1 million hip and knee replacement surgeries performed in U.S. hospitals annually, new provider registries are asking patients questions that will determine their HOOS/KOOS.

Come again, you say?

Yes, it's an odd phrase for such a serious subject.

HOOS/KOOS stands for hip disability and osteoarthritis outcome score and knee disability and osteoarthritis outcome score. These are 40- and 42-question surveys that ask about patients' pain levels, symptoms, stiffness, function during sports and recreational activities, and quality of life before and after joint replacement surgeries.

The surveys aim to determine whether a surgery has restored a person's ability to do what she used to do, or what she expected she'd be able to do, and whether it alleviated her suffering.

This is the sort of functional data that has so far been missing from Medicare's Hospital Compare, which recently began disclosing hospital-level rates of 30-day readmissions and serious complications for patients undergoing joint replacement surgery. Readmissions and complications are, of course, extremely significant.

But some might argue that it's also important to know whether patients got the results they anticipated, and whether they perceive that they are worse or better off months later.

Down the line, private payers may tether the price they'll pay for some procedures, at least in part, to how well a surgeon scored on these kinds of surveys. It's another form of value-based contracting.

Registries Abound

Evolving state registries to measure such fine points of patient outcomes include the California Joint Replacement Registry (CJRR), the Virginia Joint Registry, and the Michigan Arthroplasty Registry Collaborative Quality Registry (MARCQI), as well as a national network called the American Joint Replacement Registry (AJRR).

These organizations seek to answer questions about surgeon and hospital proficiency after patients have lived with their new joints for periods of time. Most of the registries use versions of HOOS/KOOS, among other quality and safety indicators.

Now, there's an even larger database on the scene, the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE TJR). I know, it too has a funny name, like a video game set in outer space.

Co-directed by Patricia Franklin, MD and David Ayers, MD, of the University of Massachusetts, FORCE TJR was funded with a $12 million grant, now expired, from the federal Agency for Healthcare Research and Quality.

To date, Franklin says, FORCE TJR has amassed pain and outcome data for 30,000 surgeries performed by 150 surgeons at 70 hospitals in 24 states. For the bulk of those surgeries, the network has collected more than two years' worth of follow-up data. All patients added to the registry are followed indefinitely.

And while the data is not public, FORCE TJR has used results from 25,000 of those surgeries to create demographically representative benchmarks so various kinds of hospitals and a representative sample of surgeons can compare their risk-adjusted scores.

Now, the network is trying to recruit more doctors to join the registry. It's been "ahead of the others in implementing this and making it mandatory for every patient" so that surgeons and hospitals that participate can't cherry pick the patients who get surveyed, Franklin says.

An important factor in creating and implementing registries is how surgeons learn from information they receive, or from those who get higher scores, especially if it shows wide variation in scores, such as infection rates.

Nationally, she says, the average 90-day all-cause complication rate from hip and knee replacement surgeries is 4.5%, but the variation is nearly four-fold, from 2.2% to 8.9%.

It's Only Good If It's Used to Improve

Reports have suggested that because surgeons are busy and lack support from their hospitals, they may not have an opportunity to learn from better performers or implement practice changes to improve their own results.

After getting less than desirable scores, a surgeon from one orthopedic practice told Franklin that now, there's someone available to answer patients' questions more promptly after they're discharged, and schedules are always rearranged to see patients "the next morning" if there's a concern about redness or swelling or pain near the incision.

Without prompt attention, a patient might go to the emergency department "and see someone who didn't know the patient or know about their surgery."

Another benefit is that results are relayed back to the hospital and surgeon every quarter, unlike data now posted on Hospital Compare, which is usually at least two years old. "Often, this is the first time that the surgeon really [has gotten] this kind of feedback," Franklin says.

In time, she imagines that the Centers for Medicare & Medicaid Services will publish FORCE TJR data, perhaps in aggregate or as a composite, either on Hospital Compare or Physician Compare.

"The question is, what data will be useful to the public? That's what Hospital Compare will have to test. I imagine we will get there in time. But it will have to be information that is meaningful to the patient," and information that will show variation as well, Franklin says.

U.S. News & World Report may soon publish names of hospitals and whether they choose to report if their orthopedic surgeons are participating in such a registry, she says. That's at least a start.

Several insurance companies are already using models to collect data like this from surgeons.

With so many aging baby boomers insisting on high levels of physical function into their senior years, hip and knee replacement procedures can only be expected to grow. In 2011, according to the National Center for Health Statistics, there were more than 710,000 knee replacements, and more than 460,000 hip replacement procedures. Their costs were $11.31 billion and $7.96 billion, respectively.

I just hope all of this quality data is available publicly if and when I need to get one.

http://www.healthleadersmedia.com/print/QUA-314942/Functional-Outcomes-Data-for-Joint-Replacement-Ups-the-Quality-Ante

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