Please Support Ariel Grace's Law HR5403

June 10, 2016

The Honorable __________________

___________________ HOB

Washington, DC 20515

Dear ________________________, 

H.R.5403 Ariel Grace’s Law  https://www.govtrack.us/congress/bills/114/hr5403

On June 8, 2016, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced an important new bi-partisan bill.  This bill seeks to remove the preemption protection granted to Class III medical devices which receive initial premarket approval by the FDA.  Accordingly, manufacturers of medical devices, which  later may be shown to be defective and dangerous, will not be automatically shielded from liability.  Often the threat of civil litigation is the necessary force to ensure that manufacturers provide medical devices that are both effective and more importantly, safe. A similar bill had over 100 cosponsors several years ago, and we hope to drive similar bipartisan support.

The bill is aptly named, Ariel Grace’s Law, after Ariel Grace Burrell, whose stillborn birth was caused by a Class III medical device. Kristiana Burrell has given her blessing to have the bill named after her daughter and the bill was introduced on the one year anniversary of the birth/death.

This  bill is  applicable to all Class III medical devices. It is an amendment to an already existing statute and merely amends the statute to allow access to courts for those injured by defective medical devices and is states as follows:              

This Act may be cited as the “Ariel Grace’s Law

(a)  Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:

(b)  NO EFFECT ON LIABILITY UNDER STATE LAW- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”

(c)  EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall

(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and

(2) Apply to any civil action pending or filed on or after the date of the Act.

As your constituent, I strongly urge your support of this bill. It is unconscionable and unjust that manufacturers who have a medical device approved by the FDA pursuant to a  premarket approval process can be forever shielded from liability and immune from suit even when the device later proves to be dangerous and/or defective and causes injury to device users. It was never the intent of the Federal Food, Drug and Cosmetics Act to provide blanket immunity for medical device manufacturers for defective devices placed into the stream of commerce.  Quite simply, there is no plausible reason nor rationale for the failure to support this amendment, which serves to protect your constituents.  Accordingly, I strongly urge you to join forces with Representatives  Fitzpatrick and Slaughter and make this bill into law as soon as possible.

My best,

Bayer Alters 'Essure' Adverse Event Reports

Fitzpatrick Questions FDA About Essure Reporting

April 19,2016 (FiDA highlight)

WASHINGTON, D.C. — Congressman Mike Fitzpatrick (PA-8) sent the following letter to the Food and Drug Administration Tuesday regarding dramatic changes in the reporting of adverse events caused by the medical device Essure:

Dear Dr. Shuren,

Information has been brought to my attention that shows a dramatic change in how Adverse Event Reports relating to the permanent sterilization device Essure were submitted to the FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.

As you know, when a manufacturer submits an Adverse Event Report to the FDA one of the data fields to be filled is “Reporter Occupation.” Examples of how that field can be coded by the manufacturer include “Physician,” “Health Professional,” “Nurse,” “Pharmacist,” “Paramedic,” “Risk Manager,” and “Other.”

As it relates to Essure, from January 2002 through June 2015, the manufacturer of the device submitted nearly 600 Adverse Event Reports in which the “Reporter Occupation” field was coded as “Physician.” This corresponds to the narrative information included in the report in which it clearly states the information in the report came from a medical doctor, a Gynecologist/ Obstetrician, a physician, or other similar term.

However, this coding changed dramatically in July 2015. I find this extremely concerning given the fact that on July 17, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.

After the FDA’s public announcement, Adverse Event Reports received by the agency from the manufacturer of Essure no longer coded reports from medical doctors as Physician reports. Instead, almost every report received from a physician between August 2015 and February 2016 listed the Reporter Occupation field as “Other.” This is a clear change from how the manufacturer coded prior to FDA’s announcement despite the same keywords, like medical doctor or Ob/Gyn, being found in the narrative portion of the reports. A similar change was noted in reports received from nurses.

I respectfully request the FDA to review the Adverse Event Reports from physicians and provide answers the following questions:

1. Did the FDA request the manufacturer to change how it was coding physician reports?

2. If the FDA did not request this change, is there a legitimate basis by which a manufacturer would suddenly change how they code reports from medical doctors and Ob/Gyns and code the occupation as “Other” instead of as “Physician”?

3. Was the FDA aware of this change?

4. Did the manufacturer of Essure notify the FDA it was changing how it reported the Report Occupation field within the Adverse Event Reports?

5. Was the FDA aware of this change prior to the September 24, 2015 Advisory Committee meeting related to Essure?

6. Does the FDA review Adverse Event Reports with the Reporter Occupation field coded as “Physician” differently than reports coded as “Other?” Are “Physician” reports given more weight when FDA is reviewing Adverse Event Reports than reports coded as “Other?” If so, please describe the differences in how the FDA reviews a report received from a physician compared to other types of reports.

7. If the FDA were to generate a list of Adverse Event Reports received from “Physicians” about Essure, would reports coded as “Other” be included? If the Reporter Occupation is listed as “Other,” does the FDA conduct additional analysis of the narrative portion of the report to determine if the report came from a medical doctor?

8. Is it illegal for a manufacturer to knowingly manipulate data listed on an Adverse Event Report?

9. What are the penalties for knowingly submitting false information to the FDA in an Adverse Event Report?

10. Has the FDA ever held a manufacturer accountable for falsifying or intentionally miscoding information submitted in an Adverse Event Report?

I appreciate your prompt attention to this request. Should you have any questions, please do not hesitate to contact Justin Rusk on my staff.

Sincerely,

_______________________________________________________

Statement of Dr. Zuckerman on Bayer’s adverse reports on Essure

Statement of Dr. Diana Zuckerman, President

National Center for Health Research

Bayer’s vague labeling system of Essure contraceptive problems brought to Congress’s attention

April 19, 2016

This seems to be a clear attempt by Bayer to make the adverse reports regarding Essure seem less credible. By counting physicians and other health professionals as “other,” Bayer assumed correctly that the FDA would take them less seriously. And, the same thing would happen when the FDA reported those adverse events.

This is not the first time that Bayer has misrepresented information about the risks of Essure, and it is time for the FDA to realize that they can’t trust the information that the company is providing.

FDA and Bayer Essure Asked to Explain: 303 Fetal Deaths and Kickbacks

FITZPATRICK QUESTIONS FDA OVER ESSURE DATA, ALLEGED KICKBACKS

Jeffrey Shuren, M.D., J.D.

Director, Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

February 16, 2016

Dear Dr. Shuren,

As you are aware, thousands of women have filed formal complaints to the Food and Drug Administration regarding the permanent contraceptive device Essure. These injured women have reported numerous symptoms related to this FDA-approved device, such as extreme pelvic pain, allergic and immunological reactions, heavy bleeding, unexplained weight gain, loss of teeth and hair, and broken coils migrating throughout their body and puncturing internal organs.

Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths.

However, my office is in receipt of a review of adverse event reports related to Essure, conducted by women harmed by this device and an adverse event data expert. This independent report counts 303 fetal deaths. A copy of this report is enclosed.

In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device.

Additionally, my office is in receipt of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the United States of America, 27 States, and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare, LLC. A copy of the complaint is enclosed.

The complaint alleges that the manufacturer of Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient.

According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000. Additionally, the complaint alleges that the manufacturer of Essure would set up “referral lunches” to generate business by connecting primary care physicians and Ob/Gyns to create what the manufacturer called “coin-operated doctors,” designed to lead to the increased use of Essure. Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.

These alleged illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare.

In addition to the review of 303 fetal death reports, I request that the allegations of illegal kickbacks filed against the Essure manufacturer also be included as part of the review being conducted by the FDA.

Sincerely,

Mike Fitzpatrick

Member of Congress

http://www.modernhealthcare.com/article/20160217/NEWS/160219918/congressman-says-fda-grossly-underestimated-harm-of-permanent#comments

http://bit.ly/1PRfMor

Congressman says FDA grossly underestimated harm of permanent contraceptive Essure

By Shannon Muchmore  | February 17, 2016

A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks.

Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns.

“They came together as a group frankly because nobody would believe them, not even their own doctors,” he said.

Madris Tomes, a medical-device reporting expert with Device Events, said she searched publicly available FDA data to find 303 reports of fetal deaths, a stark contrast to the five previously reported by the FDA, the agency responsible for evaluating the device's safety and usefulness.

The FDA was not immediately available for comment.

Fitzpatrick also discussed a complaint filed in the U.S. District Court for the Northern District of California that alleges doctors received $20,000 of free medical equipment for agreeing to buy 25 Essure kits.

The complaint also states that manufacturer sales representatives would organize lunches with primary-care providers and OB-GYNs, to generate more referrals to the OB-GYNs who produced the most revenue and advertised the most. The sales team internally referred to such providers as “coin-operated doctors.”

Fitzpatrick said he is coming forward with the information before the FDA is expected to release new guidance on the use of Essure later this month so that the agency can take it into account.

Essure can be installed by a doctor at a regular office visit lasting less than an hour. A small, flexible coil is inserted into each fallopian tube, causing scar tissue to form and block eggs from getting into the uterus.

The FDA approved the procedure in 2002 and Bayer bought the device from Conceptus in 2013. Some women who had the device implanted, however, said they suffered from intense pain and heavy bleeding. Complaints also included fetal deaths and uterine perforation.

The FDA issued an alert in June after a search of its Manufacturer and Use Facility Device Experience Database found more than 5,000 adverse-event reports. 

In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe. The panel took no formal vote, however, and did not take the product off the market as many advocates had requested.

Fitzpatrick, who has introduced a bill requiring the FDA to pull its approval of Essure, sent a letter this week to the director of the FDA Center for Devices and Radiological Health, outlining the findings and requesting an immediate review.

FDA Approved Medical Device Being Blamed For Countless Injuries, Medical Conditions

February 17, 2016 1:51 PM By Mike Dougherty

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

PHILADELPHIA (CBS) — Congressman Mike Fitzpatrick is calling for the Food and Drug Administration to ban the use of a medical device that’s been the source of tens of thousands of complaints.

Bayer Essure is implanted into the fallopian tubes for permanent sterilization, but women are reporting widespread complications and even death.

Essure has an FDA gold stamp of approval, but Congressman Fitzpatrick says it’s responsible for more than 300 fetal deaths and countless other medical complications.

It goes deeper. Fitzpatrick says kickbacks from Bayer, the manufacturer provided illegal financial incentive to doctors.

“The manufacturer is providing free marketing and advertising services to OB/Gyn. They were encouraging them to use Essure on their patients, and they were making a lot of money.”

Fitzpatrick says money from insurance companies, tax payers and women like Amanda Dikeman, who went through years of pain and suffering before the device was removed.

“My once very thick hair began falling out in clumps. I battled continuous urinary tract and kidney infections.”

Lawmakers want to know why it took so long for the FDA to receive patient complaints and why nothing has been done about them.

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

Women Want Bayer Essure Taken Off Market

Essure is a medical device that gets surgically inserted into a woman's fallopian tubes. It's marketed as a form of permanent sterilization for women, but it's been linked to more than 300 fetal deaths, and a group of 27,000 women on Facebook want to see it taken off the market. KYW's Mike Dougherty reports.

Mike Dougherty  Mike is a general assignment reporter and editor for KYW Newsradio 1060. His career at 1060 began as a desk assistant in January '07. A short nine months later, he was promoted to AM Drive writer while still studying broadcast journalism at Temple...

How Many Adverse Events Does It Take to Get Bayer Essure Recalled By FDA? MORE !!!$$$???

Birth-control device under FDA review

By Maryellen Fillo, Conn. Health I-Team Writer | February 1, 2016 (FiDA highlight)

• 

Alyson Hannan, of Farmington, is among the women who have had problems after having the Essure birth-control device implanted.

When Alyson Hannan, 44, decided she was done having children, she chose Essure, a non-surgical, permanent birth-control option approved by the Food and Drug Administration.

The day the tiny metal coils were inserted into her fallopian tubes in her doctor’s office is one that she can’t forget, said Hannan, regional sales director for Met Life who underwent the procedure on Sept. 11, 2014. “I will never forget that date. None of us will.”

Hannan is among tens of thousands of women, now referred to as “E-Sisters,” who have banded together on Facebook to share their stories of adverse health problems, including allergic reactions, chronic pelvic pain, device migration, hair loss and headaches.

Their public clout and a citizens’ petition prompted the FDA to launch a review of Essure, and U.S. Rep. Mike Fitzpatrick (R-Pa.) to sponsor legislation calling on the FDA to withdraw its approval for use. The controversy will come to a head in February, when the FDA is expected to complete its review, and when members of the “Essure Problems” Facebook group are heading to Washington to lobby Congressional members to support Fitzpatrick’s “E-Free Act.”

The concerns over Essure have been fueled by a January report by a federal watchdog agency, conducted at the request of U.S. Rep Rosa DeLauro, a Democrat from Connecticut’s 3rd Congressional District, that faulted the FDA for failing to adequately track and disclose safety concerns that arise after drugs go on the market. Inspectors from the Government Accountability Office expressed particular concern about the lack of tracking of products cleared under two expedited approval programs.

The lack of inadequate pre-marketing and post-marketing studies of Essure was highlighted in a recent article in the New England Journal of Medicine that was co-authored by Yale University School of Medicine researchers.

DeLauro, was among the first members of Congress to speak out against Essure, writing to the FDA in October to say she was “deeply disturbed by reports from women about severe adverse health effects they have suffered…” and calling on the agency to withdraw Essure from the market.

Essure, approved by the FDA in 2002 for women ages 21 to 45, is a flexible coil that is inserted into each fallopian tube in a doctor’s office. Essure is made of nickel titanium alloy and a polyester-like fiber called polyethylene terephthalate, or PET. The procedure, performed in a doctor’s office, takes about 10 minutes. The medical device was originally manufactured by Conceptus, which was purchased by Bayer HealthCare in 2014. Once inserted by an OB-GYN, scar tissue forms around it, blocking the tubes and preventing eggs from being fertilized.

Varying experiences

An estimated 750,000 women have received Essure. Warnings on the product include side effects such as mild cramping, vaginal bleeding and some temporary discomfort.

In response to the public outcry, Dr. Dario Mirski, Bayer’s vice president and head of U.S. medical affairs, said, “Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.”

“We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure,” Mirski said in a press release.

The FDA has received 5,093 medical device adverse reports on Essure, a majority of them citing abdominal pain, irregularities in menstrual cycles, fatigue and possible nickel allergy. Some women have reported perforation of the uterus and/or fallopian tubes or intra-abdominal or pelvic device migration. Four adult deaths and five fetal deaths were also reported, according to the FDA.

In September, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to discuss the risks and benefits of Essure and received over 2,800 written public comments. The FDA said that it expects to complete its review by the end of February.

In the meantime, members of the “Essure Problems” Facebook group are heading to Washington on Feb. 2 to speak to Congressional members to garner support for Fitzpatrick’s “E-Free Act.”

In Connecticut, doctor’s opinions on the device vary. Dr. Henry Jacobs, an OB-GYN and president of the Connecticut State Medical Society, said he used Essure when it was first introduced, but does not generally use it now, opting instead for tubal ligation, another permanent sterilization procedure.

“There were too many factors that made me say, ‘Hey, I can do this another way’,” Jacobs said. “I think Essure is worthy of a review.”

Dr. Russell Turk of the Stamford Health Medical Group said, “Overall I feel it is good but I have had a couple of things occur but nothing bad.”

“As with any form of contraception, there are always benefits and risks,” Turk said, whose office is in the Riverside section of Greenwich.

Turk said he does the outpatient procedure in Stamford Hospital’s Tully Health Center, rather than his office.

“I don't like the idea of fishing around in a uterus in an office setting,” said Turk, noting some bigger medical groups might have more sophisticated equipment.

He said he goes to the center because “sometimes there can be problems with the insertion and if that happens we have other options like a laparoscopic tubal and are in a safe setting with the right equipment and can proceed.”

At first, Turk said he instructed his patients who wanted the Essure device to have a nickel allergy test but was advised it wasn’t necessary. He said he has never had a patient who suffered any allergic reaction to the device.

“I do ask patients if they have a nickel allergy or if they think they might,” Turk said.

Turk said his patients have requested Essure and he offers it.

“I don’t think anyone feels there is never a possibility of something going wrong,” he said. “There is no perfect form of contraception other than abstinence.”

‘E-Sisters’ ranks grow

Dr. Odie Kuiper, an OB-GYN in Avon, said he has used Essure nearly 200 times with no reported problems, but is very careful to review risks with his patients.

“I understand the request for (FDA) review, because no one wants anything that is not safe for a patient,” he said. “But I don’t think the adverse effects are common enough to take the device off the market.”

Angela Desa-Lynch of California, one of the founders of “E-Sisters,” doesn’t want to leave the decision up to the FDA.

“In 2011, when we started the page, we had just 130 women — at a time when the horrible side effects of the implant were not well publicized, and everything was all gumdrops and candy canes,” she said. “Now we are over 25,000 members, and our mission is to save other women from what we have been through.”

Desa-Lynch, the mother of two sons and a daughter, had a hysterectomy to remove the coils, after it was determined she was allergic to the materials used in the device.

“I lost my hair, my teeth and felt like I always had the flu,” she said.

“It changed my life, and I don’t want my daughter to ever have it as an option. I don’t ever want her to have the opportunity to choose Essure,” she added.

Angie Firmalino, another founder of the Facebook group, said the goal is to get the device off the market.

“We plan to continue to garner for support of the ‘E-Free Act,’ ” said Firmalino, of New York. “We suspect the FDA report will call for minimal requirements for the manufacturer to change labeling and such. We need Congress to act and revoke the pre-market approval of Essure so that the civil rights of women harmed by Essure can be restored.”

Hannan, of Farmington, has coped with years of severe backache and pelvic pain; long, heavy periods; insomnia; fatigue; weight gain; and a rash and boils that covered her body. She’s missed work, her children’s activities and other social events because of the way she feels and looks.

“It has been a nightmare,” said Hannan, who is scheduled for a hysterectomy in early February to remove the coils. “I don’t think the doctor had any reason to not believe it was safe until it was too late,” she said.

Hannan’s doctor, Jennifer Grant, who is in practice at the Women’s Comprehensive Health Center and on the staff of Hartford Hospital, will perform the hysterectomy. She said that she has used the Essure device for over eight years, and that Hannan is the only one to report a problem.

“I am very curious to see if her symptoms improve after it is removed,” she said.

Hannan is convinced that once the device is removed, her health will improve. But her longer-term mission is to protect other women from the device.

“I honestly feel the product was fast-tracked due to money, and in the quest to make money, they ignored what happened to 25,000 women,” she said. “I just want it out of me. I just want to be well again.”

This story was reported under a partnership with the Connecticut Health I-Team (www.c-hit.org).

http://m.ctpost.com/news/article/Birth-control-device-under-FDA-review-6794314.php

The Supreme Court Blocks Civil Rights of Medical Device Harm Citizens

Essure Harm Shielded by the Supreme Court

Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.

FRIDAY, JANUARY 8, 2016, 10:52 AM

One of the underlying tenets of our free-market is that consumers alleging harm should have legal recourse in our court system. And the 14^th Amendment of our Constitution guarantees citizens equal protection under the law.

So, if a product or service is unreasonably harming people, the court system usually provides feedback to the supplier and problems are removed.

But, if legal barriers prevent consumers from taking their cases to court, harmful products and services will persist in the market.

That’s the scenario playing out in the multi-billion-dollar medical device sector of our economy.

Most Americans do not realize that when the Food and Drug Administration (FDA) approves “high-risk” devices through its “Pre-Market Approval” (PMA) pathway, these devices are automatically shielded from litigation. This shield was created by the Supreme Court in the 2008 decision, Riegel v. Medtronic.

You can read about Riegel v. Medtronic here and here.

The presumption is that if and when a PMA device harms people, recourse will be provided through FDA review. But, unfortunately, FDA and, in particular, its Center for Devices and Radiological Health (CDRH) is a “captured” agency. What that means is that the FDA process is overly influenced by industry advocates, at the expense of patients.

Here is a clear example of why CDRH is considered a “captured” agency by prominent FDA watchdog groups.

When the federal government, on the one hand, blocks consumers’ access to state courts and, on the other, takes on the job of addressing allegations of harm outside of a courtroom, that’s not the free-market working - it’s Big Brother at work. And that’s the process protecting PMA-approved devices.

A specific example of this problem is playing out in the case of a device used to permanently sterilize women. This PMA-approved device is known as Essure, made by a German company, Bayer Health.

You can read about Essure here and here.

More than 25,000 women across the United States claim they have been harmed by Essure, but they do not have access to the state court system.

FDA did conduct a hearing on Essure in September 2015, but last I checked FDA is not an arm of the Department of Justice.

Pennsylvania Congressman Mike Fitzpatrick is fighting to overturn Riegel vs. Medtronic.

On Dec. 6, he introduced an amendment proposing the removal of all barriers to civil litigation in product liability cases against medical devices.

You can watch him introduce this amendment here at 41:50.

But Fitzpatrick’s amendment was rejected, based on technicalities, by the House Rules committee. So it will not come up for a vote in the House.

Incredibly, those voting against the amendment were Fitzpatrick’s Republican colleagues – the supposed guardians of “free-market” economics and vocal critics of federal government protectionism over the market.

Democrats are also rejecting rep. Fitzpatrick’s call to remove Essure from the market, despite many in that party who advocate for women’s health and patient safety. The party machine won’t support Fitzpatrick’s E-Free Act.

Meanwhile, Bayer is defending its product and claiming that the harm done to a relatively small group of otherwise healthy women is to be accepted given the product’s supposed benefits.  

But our country was built on protecting minority groups who are wrongly harmed.

Fitzpatrick’s position on Essure and Riegel offers Republicans an opportunity to live up to their free-market ideology and to claim women’s health as a real Republican platform – but many are failing to see this. 

Read more at http://www.philly.com/philly/blogs/healthcare/Essure-Harm-Shielded-by-the-Supreme-Court.html#ZJTeV8mB59FL1LhF.99

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

Bayer Essure Failure Rate 10%: E-Free Act

Fitzpatrick’s E-Free Act Would Take Essure Off the Market

By Jay W. Belle Isle - Oct 27, 2015

U.S. Representative Mike Fitzpatrick (R-PA) is set to introduce a bipartisan bill to Congress regarding the dangerous Bayer HealthCare product Essure. This purportedly “permanent” birth control device not only doesn’t work, but has caused countless women incredible suffering. Fitzpatrick’s E-Free Act would take Essure off the market.

Essure is a flexible, nickel-titanium coil that is surgically implanted into the fallopian tubes. The resulting scar tissue is supposed to render the user sterile. However, studies have shown that the failure rate (i.e., number of women who’ve become pregnant) is almost 10%. Furthermore, the coil often migrates causing perforation damage and the nickel is causing multiple serious allergic reactions.

Fitzpatrick chose the November 4 introduction for the E-Free Act as that is the 13th anniversary of Essure getting premarket approval from the FDA, despite the review panel’s misgivings. The FDA held a committee hearing on September 24 to review Essure’s safety and efficacy, but no recommendations have yet been made to the agency.

Fitzpatrick issued a statement saying, “Bayer is a trusted name in the industry. However, right now, one of their products, the Essure device, is harming women and needs to be removed from the market. I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”

One of the Congressman’s spokespeople said that his office has heard from hundreds of women complaining about Essure. Bayer’s spokeswoman, Tara DiFlumeri, countered that by stating that more than 10 years of research support Essure’s safety.

“Bayer stands by the positive benefit-risk profile of Essure and we look forward to working closely with the FDA as it considers the advice of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee,” she said. Bayer’s highest priority is patient safety and we sympathize greatly with any woman who may have experienced problems following an Essure procedure.”

Sure, there’s more than 10 years of Essure research out there. Internal documents have shown that Bayer “adjusted” some of that research, skewing it such that the FDA would grant premarket approval.

Bayer is no more sympathetic to the women victimized by its irresponsibility than is the FDA, which, despite its claims, turns a blind eye toward the suffering. Victims of Essure were not allowed to speak at the September 24 hearing; only medical professionals and industry representatives were heard.

The FDA may try to get away with silencing Essure victims, but Congress will hear these brave women this week. Below is a press release from Essure Problems, an advocacy group comprised of women injured by Essure:

“Four administrators of the Essure Problems Facebook page, Angie Firmalino, Amanda Dykeman, Lisa Saenz, and Melanie Goshgarian, their congressional liaison and E-Sister Amanda Rusmisell, E-Sister and scientist Tess Shulman, attorneys Marcus Susen and Holly Ennis, and local DC E-Sister Lisa Fouser, will be attending multiple congressional meetings tomorrow and Wednesday. The goal of their meetings is to gain support for Congressman Fitzpatrick’s E-Free Act. Congresswoman Rosa DeLauro has co signed the E-Free Act, and they will be presenting it to congress on November 4th, 2015, on the 13 year anniversary of the approval of Essure. The act asks that the FDA revoke PMA status for Essure and also remove it from the market. The meetings are listed below.

They will also be handing out packets to every single congressman and woman’s office. The packet can be viewed by clicking here.”

Joleen Chambers · Illinois Institute of Technology

The medical device industry has insinuated itself into our local, state and national government by lobbying for legislation that would protect it from accountability for unsafe and ineffective products. In addition, the FDA that is charged with protecting patients by regulating the industry is deeply financially conflicted with both Director Shuren (his wife Allison is a partner in a DC lawfirm specializing in medical devices and FDA clearance) and the members of advisory panels that are salaried by the medical industrial complex. There is no process for harmed patients to be heard.

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