The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

Kirsten Clodfelter  JUN 30, 2017 @ 07:05 AM   FiDA highlight

Dr. Amy Reed, an anesthesiologist and patient-safety advocate, died in May 2017 after a four-year battle with leiomyosarcoma of the uterus. The cancer was spread by a power morcellator, the medical device used for her 2013 hysterectomy.

The surgical tool, released in 1995, was once lauded for facilitating minimally invasive surgery that decreased recovery times and minimized the risk of post-surgical infections. Morcellation, used to remove uterine fibroids or conduct complete hysterectomies, was performed on approximately 50,000 women a year in the U.S. in the early 2010s.

Yet for patients like Dr. Reed, whose uterine fibroids appeared benign but hid an aggressive type of cancer, morcellation can become a death sentence. The device is equipped with a spinning blade, which slices up tissue for removal piece by piece through small incisions. When the blade cuts through a cancerous tumor, it sprays malignant cells around the body, spreading the disease. Following her procedure, Dr. Reed, a mother of six, was left with advanced, Stage 4 cancer.

to be continued on Forbes website:  https://www.forbes.com/sites/kirstenclodfelter/2017/06/30/the-fda-owes-patients-improved-medical-device-regulation-after-dr-amy-reeds-death/#400df9afdc90

Dr. Amy Reed Dies at Age 44, Mother of 6 Children and Advocate for Safe Medical Devices

Amy Reed, Doctor Who Fought a Risky Medical Procedure, Dies at 44

By DENISE GRADY

MAY 24, 2017  (FiDA highlight)

Dr. Amy J. Reed, a physician and cancer patient who turned a personal calamity into a crusade to spare other women from the medical procedure that harmed her, died on Wednesday night at home in Yardley, Pa. She was 44.

Dr. Amy J. Reed and her husband, Dr. Hooman Noorchashm, in 2014. (MATTHEW CAVANAUGH FOR THE NEW YORK TIMES)

Her husband, Dr. Hooman Noorchashm, said the cause was leiomyosarcoma of the uterus, a type of cancer.

Dr. Reed and her husband fought for years to ban the use of a surgical tool called a power morcellator, which has a spinning blade that slices up tissue so it can be extracted through small incisions. Though the device is regarded as a great boon to minimally invasive surgery, if a patient has cancer, as Dr. Reed did, morcellation can spread the disease.

Dr. Reed and Dr. Noorchashm (pronounced NOOR-chasm) won some notable victories. Because of their efforts, the Food and Drug Administration studied morcellation and in 2014 recommended that it not be used in the “the vast majority” of women having surgery for uterine fibroids, a common tumor that is usually benign but that can hide a dangerous type of cancer.

Some insurers began declining coverage for morcellation, and one major manufacturer took its morcellators off the market. Use of the technique dropped.

Dr. Reed, an anesthesiologist and the mother of six children, underwent surgery involving morcellation in 2013, when, at 40, she had her uterus removed because of fibroids. The operation was performed at Brigham and Women’s Hospital in Boston, which is affiliated with Harvard Medical School, where both Dr. Reed and Dr. Noorchashm had teaching positions. A biopsy after the operation found that Dr. Reed had a hidden leiomyosarcoma, an aggressive type of cancer.

Only then were Dr. Reed and her husband told that her surgeon had used a power morcellator to slice up her uterus. The device allows doctors to work through small slits rather than big, open incisions, so that patients can heal faster and run less risk of bleeding and infection.

At that time, morcellation was performed on 50,000 women a year in the United States to help remove fibroids, or to remove the entire uterus.

The device had sprayed malignant cells around inside Dr. Reed’s abdomen, leaving her with an advanced, Stage 4 cancer.

As physicians, Dr. Reed and Dr. Noorchashm knew at the time that her morcellation procedure could be a death sentence. As a surgeon himself, Dr. 

Dr. Reed quickly embarked on a series of aggressive treatments, but she still suffered one recurrence after another, in her abdomen, lungs and spine. She had several major operations and received arduous courses of chemotherapy, radiation, immunotherapy and experimental treatment.

The couple fought the medical establishment as fiercely as they did the cancer, seeking to ban morcellation. They sent thousands of emails to the F.D.A., device makers, hospitals, legislators, professional societies and individual doctors, and they reached out to news organizations to publicize their cause.

Dr. Noorchashm also collected the names and histories of women whose cancer had spread after morcellation, enlisting them, or their survivors, in the crusade.

Dr. Amy Reed with her husband, Dr. Hooman Noorchashm, and their children in their backyard in Yardley, Pa., in the summer of 2015.

JENNIFER CAPOZZOLA

Their activism, alienating some colleagues and aggravating administrators, came at a price. Dr. Noorchashm had been a rising star in cardiothoracic surgery at Brigham and Women’s, where his wife had the operation, but as he continued to criticize its gynecology department, his career there began to stall.

He and Dr. Reed were both hired by the University of Pennsylvania, and moved there in 2014. Both had extended family in and around Philadelphia.

They had apparently burned their bridges at Harvard. At one point, when Dr. Reed needed to return to Brigham and Women’s for a medical procedure, she and Dr. Noorchashm were stunned to find that the hospital had assigned a guard to inspect their bags and escort them at all times, for security reasons. Dr. Noorchashm called a lawyer. A judge put a stop to the escort, issuing a restraining order against the hospital.

The gynecology profession also fought back against Dr. Noorchashm and Dr. Reed, insisting that leiomyosarcoma was so rare that the benefit of morcellation — the ability to have minimally invasive surgery — far outweighed any risk.

Before 2013, the F.D.A. had received no reports of uterine cancers being spread by morcellators. But after Dr. Reed and her husband went public — interviewed by newspapers, magazines and TV news shows — reports began to pour in. Dr. Reed, with her hair gone and her youngest child sometimes climbing onto her lap during interviews, was a sympathetic figure.

The couple’s efforts gained traction. The F.D.A. responded by studying published and unpublished medical data on morcellation. Before then, estimates of how many women with fibroids would have undiagnosed leiomyosarcomas or other uterine sarcomas were based on studies of varying reliability, and ranged from 1 in 10,000 to in 1 in 500. But the F.D.A. concluded in April 2014 that hidden sarcomas were more common than earlier estimates had stated — and probably occurred in about one in 350 women with fibroids. The tumors are extremely difficult to detect without surgery.

Soon after the F.D.A. issued its findings, one maker of morcellators, Johnson & Johnson, pulled its devices off the market. But others remained.

In November 2014, the F.D.A. went further, recommending that power morcellators not be used in the vast majority of women having fibroid surgery. Using the device in women with undetected sarcomas, it said, “may spread cancer and decrease the long-term survival of patients.” The F.D.A. portrayed the statement as a “safety communication,” not as an announcement of a new regulation.

Morcellator use dropped significantly, but many gynecologists still favored it, and the devices remained available. Dr. Noorchashm and Dr. Reed would not settle for less than a complete ban, and continued to agitate. They prodded legislators to ask the Government Accountability Office to investigate morcellation.

In a report issued in February, the G.A.O. criticized the F.D.A.’s method of collecting data on problems stemming from morcellation, noting that the system was dependent on voluntary reports from doctors, who frequently fail to report bad outcomes.

The F.D.A. said it agreed that it needed a better system to detect harm to patients. By September 2016, the agency had received 285 reports of uterine cancer being spread by morcellation.

Amy Josephine Reed was born on March 22, 1973, in Bristol, Pa. Her mother, the former Joann Tunis, was a pharmacist and executive at the drug company Pfizer. Her father, William Reed, was a health insurance consultant.

Dr. Reed graduated from Pennsylvania State University in 1995 and went on to the University of Pennsylvania, where she earned a Ph.D. in immunology and a degree in medicine. She specialized in anesthesia and critical-care medicine.

She and Dr. Noorchashm met as graduate students and married in 2001. In 2011, both were offered teaching posts at the Harvard Medical School and clinical positions at its affiliated hospitals — Dr. Noorchashm at Brigham and Women’s and Dr. Reed at Beth Israel Deaconess. She treated victims of the Boston Marathon bombing in 2013, as well as the surviving bomber.

Besides Dr. Noorchashm, Dr. Reed is survived by her parents; her daughters, Nadia and Ava; her sons, Joseph, Joshua, Luke and Ryan; and seven siblings: Alison Perate, Andrea Kealy, Amber Trainer, Matthew Reed, Justin Reed, Daniel Trainer and Sarah Trainer.

https://mobile.nytimes.com/2017/05/24/us/amy-reed-died-cancer-patient-who-fought-morcellation-procedure.html?_r=0&referer=http%3A%2F%2Fm.facebook.com

Collision of Archaic 1976 Congressional Legislation & Power Morcellator and Bayer Essure PREVENTABLE Harm

Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA  November 18, 2015

By Matthew Bin Han Ong

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

 

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

“Are you aware of this problem?” Murphy asked Shuren. “[Johnson & Johnson] was apparently aware of the dangers of this device as early as 2006, based upon a report from Dr. [Robert] Lamparter, a pathologist from central Pennsylvania, who cited about one out of 300 samples of morcellated tissue from his hospital had evidence of a hidden cancer, which is morcellated.”

At the hearing, Murphy pressed FDA’s Shuren on how much the agency knew about these incidents.

“Let me ask another question: Brigham & Women’s Hospital was aware of the dangers in 2012,” Murphy said. “A patient by the name of Mrs. Erica Kaitz was seriously injured in 2012 by the device and then died in 2013, according to reports.

“I wonder, do you know if the hospital reported that to the FDA? Would you know?”

Shuren: “I’m not aware of that.”

Contacted by The Cancer Letter after the hearing, Brigham declined to comment. The J&J subsidiary Ethicon said the company wasn’t aware of any reportable adverse events prior to December 2013.

“Dr. Lamparter did contact the company in 2006 seeking advice on ways to collect and evaluate endometrial specimens following morcellation,” an Ethicon spokesperson acknowledged to The Cancer Letter.

However, the company spokesman said the communication didn’t constitute a reportable event. “Because Dr. Lamparter did not report an actual experience with a patient, his communication was handled as a complaint, and was not reportable as an MDR,” the spokesman said.

A story about Lamparter’s report to J&J appears here.

In an earlier statement to The Cancer Letter, FDA said it received no reports of adverse outcomes before December 2013. Since then, the agency was informed of about two dozen cases of upstaging of cancer via power morcellation at a variety of health care institutions.

FDA’s answers to questions from The Cancer Letter are posted here.

The congressional hearing this week was part of a string of investigations of the controversy stemming from widespread use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.

The questions also stem from correspondence between FDA and Rep. Mike Fitzpatrick (R-Pa.), who is not a member of Energy & Commerce. Fitzpatrick became involved in response to advocacy by his constituents Amy Reed and Hooman Noorchashm (The Cancer Letter, Nov. 13).

Reed’s uterine sarcoma was upstaged as a result of a power morcellation surgery performed at Brigham.

“Under section 519 of the [Federal Food, Drug, and Cosmetic] Act (see also 21 CFR part 803), manufacturers must report to FDA information that suggests that a device they market may have caused or contributed to a death or serious injury,” the agency said in a Nov. 12 letter to Fitzpatrick. “Moreover, user facilities must report device-related serious injuries to the manufacturer and device-related deaths to the manufacturer and FDA.

“FDA has taken enforcement action in the past against user facilities and manufacturers who fail to comply with FDA’s reporting requirements. We have generally focused our enforcement resources on manufacturers—who are required under law to investigate any MDR-reportable complaint they receive—and not on user facilities. We have found that encouraging more reporting—and more complete reporting—by user facilities is a good use of our limited resources in this area,” FDA wrote in response to Fitzpatrick’s questions.

Fitzpatrick’s letter and the agency’s response are posted here.

“You will note that it is an incomplete response,” a spokesperson for Rep. Fitzpatrick said to The Cancer Letter. “We will be sending out a full release when we get a complete response.”

Separately, the Federal Bureau of Investigation is reportedly looking into the issue, and the Government Accountability Office is investigating the controversy at the behest of 12 members of Congress (The Cancer Letter, May 29, Sept. 11).

In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging Erica Kaitz’s leiomyosarcoma via power morcellation. Kaitz died on Dec. 7, 2013, nearly two months after Reed received her cancer diagnosis at Brigham (The Cancer Letter, Nov. 26, 2014).

Her widower Richard Kaitz, a Boston real estate lawyer, said that Brigham doctors mischaracterized the risk his wife was facing when she underwent power morcellation.

“They gave us numbers—one out of 10,000—that they knew to be wrong,” Kaitz said to The Cancer Letter last year. “The Seidman, Muto article was published in November 2012. It says right in that article that multiple parties at Brigham said that the number they are quoting for the risk are nine times lower than the real risk.”

https://vimeo.com/146065667

A transcript of the exchange between Murphy and Shuren follows:

Rep. Tim Murphy: Doctors, doctors, good to have you here. I appreciate this. I want to pivot a little here to talk about and piece together postmarket and premarket analysis and to look at this. In particular, a couple of devices used in women’s health care.

One is called a morcellator. Are you familiar with the morcellator? A device that is supposed to shred tumors etc. but has been associated with complications in women in terms of actually spreading cancer for them. It’s been on the market for 20-plus years, and FDA admitted for the first time it became aware of the safety issue with power morcellators after December 2013—correspondence from a physician citing a case of a family member.

This is someone who just recently had another surgery to remove another recurrence of cancer that was spread by the morcellator. The manufacturer [Johnson & Johnson] was apparently aware of the dangers of this device as early as 2006, based upon a report from Dr. [Robert] Lamparter, a pathologist from central Pennsylvania, who cited about one out of 300 samples of morcellated tissue from his hospital had evidence of a hidden cancer, which is morcellated.

My question is, did the FDA have any evidence of these dangers in 2006 or prior to that? Are you aware of this problem?

Jeffrey Shuren: In the past, the thought was that the risk—what risk of cancer there may be for a fibroma, for a fibroid—was significantly less, and one of the things that we looked into more recently, we came to a different conclusion that the likelihood of cancer is higher.

There’s still disagreement in the community, because, as you know, the [gynecology] health care professional societies disagree. They think we have overestimated the risk of the cancer, we said we have a different perspective, and that’s why we went out and we put contraindications and warnings on the use of that device, that it should only be used in a more limited set—or offered as an option—of women, and think about primarily women who, in the absence of using the device, would no longer be able to bear children, but want to bear children, and we felt in those cases the risk of a cancer is very low. They share the opportunity to weigh in, but we scaled back dramatically how that should be used.

TM: So there’s a case where the science available at the premarket analysis has changed, and once being used in the data, you have a mechanism to go forward on this and make some changes.

Let me ask another question: Brigham & Women’s Hospital was aware of the dangers in 2012. A patient by the name of Mrs. Erica Kaitz was seriously injured in 2012 by the device and then died in 2013, according to reports.

I wonder, do you know if the hospital reported that to the FDA? Would you know?

JS: I’m not aware of that.

TM: Is there a mechanism where the hospital is supposed to report that, or the manufacturer is supposed to report that so you can do an analysis?

JS: So, user facilities have certain requirements for reporting, so do manufacturers, if they become aware of certain events. And what I can tell you is we’ve been looking into those concerns that have been raised regarding reporting.

TM: OK. In a response to Congressional inquiries about this, the FDA admitted that the one out of 350 risk does not address other types of malignancies, which, you would add to that risk, you said. They went on to say the FDA also identified studies showing that morcellated patients had worse outcomes than patients who had not undergone morcellation.

So, this is more than just the issue with just a fibroid or if it’s cancerous. It is also a question of outcomes. Is this something that the FDA is reviewing, also with regard to their stamp of approval on these things, in terms of the outcome measures?

JS: So in terms of the tests we’ve looked at, we think where we have constrained it right now, is for use—is where the benefits outweigh the risks, but we are continuing to look at new data as it arises, and if so, we will act accordingly.

TM: Thank you. There is another issue in women’s health as brought to my attention. It’s a product called Essure. It’s a permanent birth control device that went through FDA’s rigorous premarket approval process.

Yet, despite getting the agency’s approval, it’s been linked to at least four deaths and deaths of five unborn children. Apparently, a total of 24,000 women have come forward, claiming that they have been harmed by this device.

And so the question is, how it remains on the market with potential for problems, and because this has the FDA stamp of approval, these women feel disappointed—they cannot take their cases forward, and feel they don’t have any recourse.

Is the FDA also reviewing this issue as well?

JS: In fact, we held an advisory committee meeting a few weeks ago at our behest to give an opportunity to put what new evidence is on the table to assure that people who wanted to raise concerns about it had an opportunity to provide those concerns.

And we are now currently reviewing the feedback received from the advisory committee, as well as what we have heard from other people as well as the state of the evidence, and we will come out with our conclusions on that to the public.

TM: Thank you. And as this goes through, since this hearing is a lot about premarket analysis, what this comes down to is, I just want to make sure that we are aware of what mechanism you have, because I understand the science of 1996 is different from the science of 2015 and our knowledge base, but to have an ongoing mechanism for review and changes of devices and getting information there and looking at those things.

I’m glad you had some hearings on this, but I’d certainly like to know that that’s part of the system. I’m out of time, but I look forward to hearing your comments on that in the future. Thank you.

https://vimeo.com/146065667

http://www.cancerletter.com/articles/20151119_1

Injured Device Patients Blitz CDRH’s Shuren

Injured Device Patients Blitz CDRH’s Shuren

Jim Dickinson

Posted in Regulatory and Compliance by mthibault on October 19, 2015

“Hey, hey FDA, how many people have you killed today?” Not since a chanting, angry crowd of hundreds of AIDS protesters blocked the street outside FDA headquarters in 1988 has the agency seen anything like the eruption of anger that CDRH director Jeffrey Shuren saw in his email inbox in October.

The modern-day equivalent of that mass demonstration 27 years ago (it was eventually effective in getting faster reviews for AIDS drugs) consisted of hundreds of angry patients bombarding Shuren with individualized templated letters demanding that he revoke the PMA for Bayer’s Essure permanent birth control device and resign his office.

The email campaign was organized by power morcellator activist Hooman Noorchashm, a Philadelphia-area cardiothoracic surgeon, and his physician wife Amy Reed, who herself was injured by a power morcellator that spread cancer throughout her body during a hysterectomy.

Thus two separate email campaigns by hundreds of injured patients merged, both focusing on medical devices that treat the female reproductive tract.

This bifurcated effort was quickly joined by a third injured-patient campaign that co-opted Noorchashm’s email template to the extent of demanding Shuren’s resignation and the revocation of PMAs for LASIK-approved lasers.

As the forces were joining, the email campaign folded in a new element: Shuren’s wife, Allison, was discovered to be a partner at the heavily FDA-oriented law firm of Arnold & Porter, and she had medical device companies as clients. Shuren was, therefore, “literally in bed with industry,” Noorchashm alleged in emails to his network.

Publicly targeting an individual FDA official several tiers below the commissioner, who as a political appointee may be expected to bear the brunt of public attacks, is an approach that is precedent-setting. As such, it’s likely to be seen again—all the more so because many of the complaining women indicated in their emails a bitter awareness of the fact that they can’t seek redress in the courts because of FDA preemption.

Since the 2008 U.S. Supreme Court decision in Riegel v. Medtronic, devices like Essure and the LASIK lasers that have PMAs have been preempted from state court product liability claims.

According to the Noorchashm-Reed template letter to Shuren, CDRH’s “inability to properly consider the adverse consequences of nickel allergies and hypersensitivity in some [Essure] patients, as well as the evidence of fraud and data tampering at the time of this device’s approval, renders this PMA status invalid. These failures have very literally harmed thousands of young and otherwise healthy American women since 2002.”

The template left room for women to insert their own post-Essure adverse experiences, just a small sampling of which follows—

Tiki: “I have had uncontrollable bloating and nothing I do relieves it. My sex life with my husband has suffered due to constant cramping. I have had numerical infections in my abdomen no one can figure out what it is or get rid of it. I randomly break out in hives for no reason. This product has ruined my life for 6 long years it's time you listen to the women who are suffering. I now have to go through major surgery to get these terrors out of my body.’

Ambi X: “My story started August 31, 2010 when my decision was made for me to be sterilized by the essure device. From that day on, my life has been changed forever. This ‘non-surgical’ procedure has resulted in a partial hysterectomy, due to the migration of my left coil that was found through exploratory surgery to be lodged near my right kidney, and with residual side effects ranging from Chronic Fatigue, numerous autoimmune diseases and in no way am I able to be the Wife, Mother, Daughter, or Friend that I used to be.”

Tamara: “Just a few weeks after enduring the excruciatingly painful placement of Essure, I knew something was terribly wrong. I lost 10 pounds, had extreme abdominal and pelvic pain, suffered burning sensations throughout my body, blurred vision, slurred speech, muscle weakness, and other adverse effects. No one could explain my symptoms. I endured 3 months of feeling like I was being poisoned to death before I found a doctor to remove the device. In the last 3 years I have undergone 2 surgeries to remove my reproductive organs, over 20 Emergency room visits, countless doctor and specialist appointments, invasive tests, and developed fibromyalgia and allergies. I lost my ability to be gainfully employed and have had to miss time with my family. Essure has destroyed my health and my life as it was.”

Lusine: “In October of 2012, after deciding that my family was complete after having 2 beautiful children, I made the decision to get the Essure Procedure done because it was advertised as safe, non surgical and effective. Little did I know shortly after my health will dramatically start to decline. At the age of 35, I feel like a 70 year old. Getting out of bed to go to work every day has become a daily struggle.  I feel like my children have lost their mother for the last 3 years. I now have chronic pelvic pain, back pain, major hair loss, very painful and heavy menstrual cycles, dental issues, aches all over my body, extreme fatigue and depression. As a single, hardworking mother, all I can do is push forward through all the pain.”

Zenia: Immediately after Essure placement, I was diagnosed with Myasthenia Gravis, Followed by Anemia, Low Thyroid Graves Disease, Multi-function Motor Neuropathy, Fibromyalgia, and migraines. I've experienced hair and tooth loss, become legally disabled, undergone a hysterectomy, experienced severe pain, cramping, weakness, dizziness, memory loss, stuttered/slurred speech, and generalized body weakness.

An FDA spokeswoman told me the agency was aware of the email campaign, and “we are reviewing all of the emails received.” She declined to answer questions about how Shuren was managing his bloated inbox and what response he was making to the angry email senders.

Of course, in a bureaucracy like FDA, that will likely all be taken out of his hands and handled by others for him. Except for the resignation demand, which FDA’s responses (if there are any) will almost certainly ignore.

Flushed with the success of his campaign, Noorchashm sent Shuren an email on October 16 that concluded: “Dr. Shuren, I advise you to resign immediately. There are many harmed Americans who now know what you have allowed to happen from your leadership post at CDRH. Your center is not protecting the public's health, it is protecting industry interests—and that, sir, is treason against the America’s public health.”

It took four or five years for FDA to placate the AIDS protest movement of 1988, and although the 24-7 news cycle, Internet, and social media innovations since then have accelerated the pace of events and government reactions to them, it will likely take at least that long to placate the injured patient movement.

A major element that was not present in 1988 is the funding of FDA by industry in the form of user fees. This means that injured patients have “no skin in the game.”

All they can do is complain and in so doing hope to attract support from Capitol Hill, where industry has long ruled the roost through campaign contributions and PAC support.

Jim Dickinson is MD+DI's contributing editor.

GAO to investigate FDA regulation of power morcellators.

Government Watchdog to Investigate Hysterectomy Device Found to Spread Uterine Cancer

Government Accountability Office to probe surgical device that was marketed for two decades before FDA issued warnings

By JON KAMP

The U.S. Government Accountability Office confirmed Friday that it plans to investigate a surgical device that was marketed for two decades before the Food and Drug Administration warned it can spread uterine cancer.

Twelve lawmakers wrote the GAO a letter last month asking for a probe into laparoscopic power morcellators, which are bladed, drill-shaped tools gynecologists commonly used to cut up growths called fibroids in minimally invasive surgery, most often hysterectomies. The FDA last year estimated that women who undergo these procedures face 1-in-350 odds that they harbor an undetected cancer that a morcellator could spread and worsen.

“We’ve agreed to do the work,” Katherine Siggerud, managing director for congressional relations at the GAO, confirmed Friday.

In a letter earlier this week to U.S. Rep. Mike Fitzpatrick (R., Pa.), a lawmaker at the forefront of pushing for a GAO review, Ms. Siggerud said the agency accepted his request “as work that is within the scope” of GAO authority. She said the GAO would likely have the staff available to begin its work in about five months.

She said in an interview it was too soon to tell how long a probe might take. An FDA spokeswoman said the agency will cooperate with any GAO review, and does not comment on pending or ongoing investigations.

The probe will likely add scrutiny to how the FDA handled issues with power morcellators going back to 1991—when the first one was cleared for sale in the U.S.—to last year, when the agency cited evidence that the risk of hidden uterine cancers called sarcomas was much higher than many gynecologists believed. Device applications and other records show the FDA knew early on that morcellators could spread dangerous cells, but the agency said the magnitude of that risk wasn’t recognized until the issue gained prominence starting in late 2013.

“I am glad the GAO has agreed to take up this investigation,” Mr. Fitzpatrick said in a statement. “What happened with the power morcellator should never happen again.”

Rep. Louise Slaughter (D., N.Y.) and 10 other members of Congress also signed the Aug. 7 letter to the GAO.

They asked for an investigation into issues such as the FDA’s reliance on a regulatory process used to clear all morcellators for sale in the U.S.; the process has drawn criticism for being too lenient. The lawmakers also asked to know whether groups like hospitals and device manufacturers complied with FDA rules to report problems with the devices, how doctors were trained to use them and what steps the FDA is taking to determine whether morcellators are safe to remain on the market.

The FDA has defended the regulatory process used to approve morcellators and most devices as a good way to balance innovation and safety, and said that the agency is strengthening its surveillance of devices on the market. Johnson and Johnson, formerly the largest morcellator maker before it voluntarily left the market last year, has said that it wasn’t aware of any reportable events regarding morcellators and the possibility of worsened cancer until late 2013.

The FDA in November followed up on its earlier morcellator advisory by calling for a black-box warning, its strongest caution, regarding the cancer risks. The devices still remain on sale from other companies beyond J&J, although many hospitals and health insurers have curbed their use.

My comment:  I blog on FiDA Advocate blogspot.  I was trained 9/2010 at the request of FDA/CDRH to be a Patient Representative on medical device Advisory Panels.  CDRH conducts few  Advisory Panels because most (98%) new devices are cleared through the 510(k) process that simply requires the identification of a 'predicate' device and perhaps a payment of $4000.  If an Advisory Panel is called, the FDA/OSHI - Office of Special Health Issues selects the Patient Representative and this person is a NON-voting member of the panel.  Harmed patients and their advocates are rarely a part of the equation and industry has infiltrated the regulatory sphere.  The system is rigged and patient harm-for-profit is the result.  

http://www.wsj.com/articles/government-watchdog-to-investigate-hysterectomy-device-found-to-spread-uterine-cancer-1441385550

F.B.I. Investigates: Are Medical Device Adverse Events Reported?

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

By DENISE GRADY and KATIE THOMAS MAY 27, 2015

The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.

The tool, called a morcellator, has rapidly spinning blades that cut tissue into pieces that can be removed from the body through the tiny slits made during minimally invasive surgery. Morcellators have often been used in surgery to remove the uterus, but in some women with undetected cancers they have sprayed malignant cells around inside the abdomen like seeds, speeding the progression of the disease.

The inquiries were first reported on Wednesday by The Wall Street Journal, which said the agents worked out of the F.B.I. office in Newark, N.J.

Celeste Danzi, a spokeswoman for the F.B.I.’s Newark office, declined to confirm the inquiry. “We just don’t comment on the existence or nonexistence of any investigation,” she said.

In an interview with The New York Times, Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed that they had spoken a number of times to an F.B.I. agent from Newark. A retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men declined to name the agent, saying they had been warned that disclosing too much information could interfere with the investigation.

Dr. Reed, 42, an anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston. Fibroids are benign, but they sometimes hide cancer. A biopsy after Dr. Reed’s surgery found a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and radical surgery, but the cancer recurred in March of this year, near her spine, requiring still more surgery.

The couple, who have six children, have conducted a ceaseless nationwide campaign to ban morcellation. Gynecology groups have resisted, saying that sarcomas are uncommon and that morcellation makes surgery less invasive and safer for the majority of women.

In November, the Food and Drug Administration said that morcellators should no longer be used in “the vast majority” of women. But the agency did not take the devices off the market or ban their use.

Dr. Noorchashm said he contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A. He said that he and his wife spoke with the agent a number of times over a few months, and that the F.B.I. seemed increasingly interested.

Dr. Lamparter said that he had also recently spoken to the F.B.I., and that the conversation had focused on his 2006 correspondence with Ethicon, the unit of Johnson & Johnson that sold power morcellators. At that time, he warned Ethicon of the potential for the morcellators to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Johnson & Johnson withdrew its morcellators from the market last July.

Johnson & Johnson has said that after Dr. Lamparter raised his concerns, it added new language to the instructions for use of the device, and that the company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue.

In a telephone interview Wednesday, Dr. Lamparter said that he considered the change a “legal fig leaf” and that the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Penn., reported that the training they received from the company in using the device did not substantially change after he raised his alarm.

Dr. Lamparter said he initially believed that the morcellator could still be used, but not on women at high risk for cancer. However, he added, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”

Ernie Knewitz, a Johnson & Johnson spokesman, said it was unaware of any investigation.

Kate Zernike contributed reporting.

http://www.nytimes.com/2015/05/28/business/fbi-investigates-whether-harm-from-surgical-power-tool-was-ignored.html?emc=edit_tnt_20150527&nlid=50639700&tntemail0=y&_r=0

Sign up & speak up! FDA April 21: Patient outcomes and risk of medical devices

Public Workshop - An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment - April 21, 2015

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Clinical Considerations of Risk in the Postmarket Environment."

The purpose of the workshop is to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator, or member of the public actually uses the device.

Date, Time and Location:

This meeting will be held April 21, 2015, beginning at 8:30 a.m. (EDT) to 5:00 p.m. (EDT) at the following location:

FDA White Oak Campus 

10903 New Hampshire Avenue 

Bldg. 31, Room 1503 (the Great Room) 

Silver Spring, MD, 20993

Webcast

The meeting will be webcast.

Agenda

The agenda will be posted soon.

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by 4:00 pm on April 13, 2015. 

Attendance In-Person  Webcast Title     First Name * Last Name *    Email* Phone Number* Company or Organization * Request to Speak *  Yes No Topic you wish to address:

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make a comment during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that comments focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

Contact

For questions regarding workshop content please contact: Jean M. Cooper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5540, Silver Spring MD 20993, 301-796-6141, email: Jean.Cooper@fda.hhs.gov.

http://www.accessdata.fda.gov/scripts/CDRH/cfdocs/cfsud/meeting.cfm 

No Harmed Patient/Stakeholder at the WSJ Roundtable Discussion on Medical Device Regulation

Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?

Most products get to market via a fast-track process; three experts debate whether the current system makes sense

By THOMAS M. BURTON  FiDA highlight added

March 22, 2015 11:00 p.m. ET

Medical devices can save lives, but in recent years it has become clear how hazardous they are when they malfunction: metal hips that fail; bloodstream filters that fracture and prove lethal; defibrillator wires that break down.

The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps.

The vast majority of medical devices still get to the U.S. market through an abbreviated pathway, called 510(k), in which companies need only show that a new device is substantially the equivalent of a device already legally marketed.

Joining our round-table discussion on medical-device safety are Scott Gottlieb, former FDA deputy commissioner and a resident fellow at the American Enterprise Institute; Rita Redberg, cardiology professor at UC San Francisco; and Bradley Merrill Thompson, device attorney in Washington, D.C. with Epstein, Becker & Green. Edited excerpts follow.

Does the system work?

WSJ: Does the FDA’s approach stymie innovation, or do patients need more protection?

DR. GOTTLIEB: FDA’s approach to regulating devices, in contrast to its requirements governing drugs, was designed by Congress to recognize that not all devices pose the same degree of risk. Therefore, the volume of data that the FDA requires should be closely matched to the risk of the product in question.

The problem today is the FDA has deviated from the original spirit of that idea. It’s trying to apply a much more uniform and druglike approach to its regulation of medical devices, increasing the hurdles that new products must clear. At the same time, the FDA is treating more low-risk devices like they were high risk.

One example where the FDA is trying to apply a more druglike approach to devices is in the growing use of “sham” surgeries. The FDA literally asks device makers to randomly assign patients to either get a new medical product, or undergo a fake surgery [as a placebo] to simulate the same procedure. In a recent trial, involving a device for the treatment of high blood pressure, patients were asked to undergo an angiogram—a procedure with risks—without knowing if they’d get the real treatment.

The FDA began asking some medical-device makers to use dummy surgical procedures a few years ago, to make its review of medical devices more like its review of drugs. Only in the case of devices, having a placebo group often can mean obligating a patient to a fake surgery. In that setting, consumers are being asked to take a risk without any prospect of a benefit. That seems unethical, and unnecessary.

The FDA also is showing a desire to classify more things that merely inform consumers as medical devices. One example is seen in the FDA’s approach to consumer apps, like those found on an iPhone. A lot of these apps are really low risk.

MR. THOMPSON: While there are certainly some incidents of the FDA regulating devices too stringently, they are by and large the exception. You mention placebo-controlled device trials. In the example you cite, however, the FDA did not order the company to use a placebo control. That was the company’s idea. The fact that the FDA permits the use of placebo controls is hardly evidence that the FDA is overregulating.

You suggest the FDA overregulates mobile apps. In the last couple of years, it has sought to reduce, not enlarge, its regulatory oversight. For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.

Instead of sweeping, fundamental reform to either clamp down or loosen up FDA oversight, I favor continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.

DR. REDBERG: As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices. And that doesn’t begin to address the billions of dollars these devices add to health-care bills.

Only a few percent of all devices on the U.S. market go though the only pathway that requires any clinical data. And even that most-stringent pathway doesn’t require two randomized clinical trials. In fact it doesn’t even require one; this most rigorous evidence standard can and frequently is met by non-randomized trials without controls, or by case-series or even expert opinion.

These devices cannot be removed without significant risk of serious morbidity or death, as has been learned by the many women who received pelvic mesh, or had their uteri removed with the aid of morcellators, for just two of many possible examples. Yet another example of a high-risk implanted device entering the market without clinical studies is the inferior vena cava filter, which for some models, studies have shown that 1 in 4 fracture after implantation in the major blood vessel entering the heart and are risky to remove. And after metal-on-metal hips, touted as a great innovation, entered the U.S. market without clinical studies, many Americans learned the hard way that they have a fourfold increased revision rate compared with other artificial hips and leak metal ions into the bloodstream.

WSJ: Brad and Scott, isn’t it clear that too often, devices get on the market with minimal evidence of safety?

DR. GOTTLIEB: My concern is that a lot of the fundamental questions about device safety turn on issues of biomechanical performance. For example, some common questions are how resilient an implanted valve will be to the shearing effects of blood flow, a joint to constant stresses, or the durability of a pacemaker’s circuits.

The FDA is trying, in too many cases, to answer these questions by requiring longer and larger trials in people and large animals like pigs and sheep.

The issue at the heart of the tragedy with [uterine] morcellators [in hysterectomies] is a different one. Here there was a much more fundamental misunderstanding about the biology of a disease state. The FDA didn’t fully appreciate the risk of certain kinds of cancer, and how frequently they occurred.

MR. THOMPSON: The truth, I think, lies somewhere in between the extremes that [Dr. Gottlieb] and [Dr. Redberg] have staked out. I agree with [Dr. Redberg] that sometimes unsafe or ineffective products reach the market. Morcellators are indeed a recent example. That’s regrettable. However, that fact, by itself, doesn’t mean we should fundamentally change the system.

Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many. But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too.

Preventing failures

WSJ: In one of the worst failures, a Medtronic defibrillator wire, the company relied on stress testing, not a clinical trial; 268,000 patients were exposed to a wire that led to multiple deaths.

MR. THOMPSON: That problem was found eight years ago. The fact you need to go back that far speaks to the overall robustness of the FDA process.

DR. GOTTLIEB: The failure of any defibrillator lead is tragic, but to portray the malfunction of Medtronic’s lead as an example of a device failure that could have been avoided through a bigger clinical trial gives short shrift to the basic science and engineering challenges that permeate this type of problem, and how one tries to prevent it from occurring.

Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them. The U.S. is the gold standard when it comes to device safety. There are always opportunities to enhance the process. For example, the FDA is implementing a unique device identifier [UDI] system to better track device performance [after approval].

DR. REDBERG: Only a few percent of all medical devices enter the market via a pathway that requires at least some clinical data.

Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness.

We must have national, publicly available registries of devices and procedures, so that we can track in real-time the outcomes, and then truly know the benefits and the risks.

Mr. Burton is a reporter in the Washington bureau of The Wall Street Journal. He can be reached at tom.burton@wsj.com.

My comment:

"The Wall Street Journal and Thomas M. Burton have my gratitude for tackling this issue, but my dismay for having a ‘roundtable’ discussion that does not include the patient perspective.  

You do not need to go back eight years to find implanted medical devices failing.  Nearly 70,000 women are in federal court in an MDL lawsuit for failed pelvic mesh sold by more than a half dozen U.S. medical device makers.  14,000 women have met on Facebook Essure Problems to provide mutual support and begin the legal and legislative process of removing this dangerous Bayer ‘permanent’ birth control product from the market.  The company is profiting while they suppress information and harm more young women and their families.

As a trained FDA Patient Representative (9/2010) I learned what little regard the clearance process had for PREVENTABLE harm to patients.  In the ‘Informed Consent’ there is no access to non-proprietary patient outcome research on the device and no discussion of the impact of “Riegel v Medtronic” and pre-emption on the civil rights of the patient should he/she be harmed.  There is no product warranty and hospitals and doctors have a back-door way of dealing with the complex medical issues of a FAILED device:  the patient is referred for psychiatric help, a pain clinic or the doctor/patient relationship is severed by the doctor.   Harmed patients are buried alive by the perpetrators-in plain sight.”  This is legal, thanks to aggressive lobbyists for the medical device (petroleum, chemical, metals) industry.  

http://www.wsj.com/articles/do-the-fdas-regulations-of-medical-devices-need-to-be-overhauled-1427079649?KEYWORDS=FDA