No Objective Patient Outcome Data: Sacrificial Lambs

Women's health rally hopes to change legislation

Updated: May 07, 2017 9:51 AM CDT

By Kent Luetzen

MISSOULA -

Women from around the country who have been harmed by medical devices such as Essure --  a type of birth control -- used their voices to rally on Saturday. One rally was held in Missoula in hopes of raising awareness about what they call "hidden dangers" of some FDA-approved products. 

The group says women deserve better communication from doctors on the side effects of products and for manufacturers to not hide behind the FDA's pre-market approval certification.

For some of these women, products which were said to be safe have caused serious health issues including autoimmune diseases such as eczema, lupus and celiac disease.

Ray Curtis, who’s wife died from hysterectomy complications, is hoping Montana legislators will continue their work to protect women.

"They're (treated) almost like human guinea pigs. These devices are being used for purposes they weren't intended to be used for," Curtis said.  "Legislation can bring about awareness to begin with, but also get government to protect woman who are unsuspected like my wife and me... we didn't know.."

Missoula's rally was just one of over 20 throughout the United States.

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,

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

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.

NYT Editorial: FDA/CDRH STOP Bayer Essure Harm!

Safety Questions About a Birth Control Device

By THE EDITORIAL BOARD OCT. 14, 2015

The Food and Drug Administration convened a panel of experts last month to examine the safety and effectiveness of a device for permanent birth control that has generated thousands of complaints from women who say they were harmed by it.

The device, known as Essure, is implanted in a woman’s fallopian tubes to induce scar tissue formation to block the tubes and prevent eggs from being fertilized. It is an alternative to procedures that tie or cut fallopian tubes, and some 750,000 women have received the device around the world, mostly in the United States.

The American College of Obstetricians and Gynecologists considers Essure as effective as surgical procedures and safer in some respects. Planned Parenthood considers it an important option.

More than 5,000 women have reported harmful effects to the F.D.A. (this is very likely an undercount since many problems go unreported). According to the advisory committee’s summary, patients have reported persistent pain, bleeding, allergic reactions and the need to remove a faulty device and repair any damage. There have also been hundreds of unwanted pregnancies. The risks of removal are unknown because various techniques have not been evaluated in clinical studies. Many women out of desperation had hysterectomies, which they said eased their symptoms.

In addition to these complaints, a petition has been submitted to the F.D.A. by a Florida law firm claiming that the small company that developed the device committed fraud by manipulating data in the clinical trials that led to F.D.A. approval. The F.D.A. sent the complaint to its own compliance office. That is not good enough. The charges need to be investigated by an independent office free of influence from the F.D.A., like the inspector general of the Department of Health and Human Services.

The manufacturer, Bayer HealthCare Pharmaceuticals, which acquired the device in 2013, argues that the percentage of women reporting problems is low and that many of the problems are unrelated to the device.

All birth control measures carry risks and benefits. What women and doctors need to know is how this device compares with surgical procedures and intrauterine devices in preventing pregnancies and causing minimal harm. The F.D.A. needs to look hard for ways to get that information and should consider suspending sales of Essure until better data is available.

http://nyti.ms/1ZDcQCZ

Write to cures@mail.house.gov by June 13, 2014. Here's why!

21st Century Cures – Patients 

“There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”1 

For patients and their families, the gap between the number of diseases and the number of treatments is not a statistic; it is their daily struggle. Despite the medical breakthroughs of recent years, for many diseases, treatments or research simply do not exist. 

Through legislation such as the Food and Drug Administration Safety and Innovation Act and the PREEMIE Reauthorization Act, which included the National Pediatric Research Network Act, the Energy and Commerce Committee has sought bipartisan solutions to facilitate and accelerate patient access to innovative treatments. Although progress has been made, significant work remains. That is why we launched the 21st Century Cures initiative, and the involvement and guidance of those patients on the frontlines and their advocates is critical. Our goal of accelerating the cycle of discovery, development, and delivery of promising new treatments and cures is shared by many, but perhaps most of all by patients and their families. 

The committee appreciates that certain aspects of the discovery, development, and delivery cycle have different meanings for different patients. Depending on the condition or disease at issue, the state of biomedical research, and the translation of such research into treatments and cures, varies. We want to hear about the state of biomedical research and therapeutic innovation for specific diseases and better understand how Congress can help move the ball forward. 

To help the committee’s effort, we are seeking input from the patient community on the following questions: 

􏰀 What is the state of discovery of cures and treatments for your disease? Are there cures and treatments now or on the horizon? 

1 Statement of Margaret Anderson, Executive Director of FasterCures, at the 21st Century Cures Roundtable held on May 6, 2014, http://www.youtube.com/watch?v=Fr4Re7sfDzE&t=33m21s. 

• 􏰀  What programs or policies have you utilized to support and foster research, such as patient registries, public-private partnerships, and venture philanthropy?
  
• 􏰀  How can Congress incentivize, coordinate, and accelerate basic research for diseases we know relatively little about?
  
• 􏰀  How can we work together to better translate advances in science into safe and effective new therapies for patients?
  
• 􏰀  How do you coordinate your research and outreach with other patients?
  
• 􏰀  How do you learn about new treatments and cures? How do you communicate with other
  patients regarding treatments and cures?
  
• 􏰀  What can we learn from your experiences with clinical trials and the drug development process?
  
• 􏰀  What is the role of government in your work, including any barriers to achieving your goals and advancing breakthroughs?
  
• 􏰀  How should regulators evaluate benefit-risk? How do you work with regulators regarding benefit-risk? Can this process be improved?
  
• 􏰀  What is the role of public and private funding in the research and development of cures and treatments?
  
• 􏰀  Are there success stories the committee can highlight and best practices we can leverage in other areas?
  
• 􏰀  How have you worked with other patients to support one another?
  
• 􏰀  What is the financial burden of your disease? How would better treatments and cures help
  save money for your family and the federal government?
  
• 􏰀  How can Congress help?
  Public input is critical to the 21st Century Cures initiative, especially from the patient community. With the staggering gap between the number of diseases and available treatments, there are undoubtedly countless untold stories that will provide guidance and perspective in this effort. We request all submissions and suggestions be sent to cures@mail.house.gov by June 13, 2014. 

http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140516PatientsWhitePaper.pdf

Bayer Essure: PREVENTABLE failure.

Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

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By RONI CARYN RABIN  The New York Times    (FiDA highlight added)

MAY 3, 2015

When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes.

Now, 13 years later, thousands of women who claim they were seriously injured by the implant are urging the Food and Drug Administration to take the device off the market and to warn the public about its complications.

Troubling long-term data on women using the device, called Essure, was published on Friday after an unusual eight-year delay. Several patients have sued Bayer HealthCare Pharmaceuticals, and representatives of patient groups plan to meet with officials of Bayer, the manufacturer, on Tuesday to discuss their concerns.

The device is a small metal and polyester coil placed into a woman’s fallopian tubes in order to make her permanently sterile. The F.D.A. approved Essure after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery.

Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged  in other organs.

According to a citizens’ petition filed with the F.D.A., an inspector was given records of 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired a majority interest in the company. Both the agency and Bayer say Essure’s benefits outweigh the risks.

Essure is sold in at least 23 countries, Bayer officials say, and about 750,000 devices are in use worldwide. Company officials declined to say how many American women use Essure, but said serious complications were relatively rare.

“There are no signals, nothing that would indicate a problem with Essure,” said Dr. Edio Zampaglione, vice president for United States medical affairs  and women’s affairs at Bayer. “The events being reported and seen are expected for this type of procedure.”

But in interviews with more than a dozen patients, many said the risks were anything but expected.

Angie Firmalino, a 42-year-old mother of four in Tannersville, N.Y., said she had experienced severe pain and nonstop bleeding for two years after receiving the implant in 2009.

Eventually doctors discovered that the coils had somehow lodged in her uterus and had broken apart. She has had several operations, including a hysterectomy, to remove the fragments.

In 2011, Mrs. Firmalino created a Facebook page to warn friends and family about the device. The page now has nearly 17,000 members.

“If I had any idea of the possible consequences of Essure, I would never have chosen it,” said Mrs. Firmalino, who still takes ibuprofen daily to manage her pain.

In 2000, Kim Hudak was a 28-year-old mother with a 7-year-old son when she volunteered to participate in an early trial of the device. But as soon as she received the implant, she said, she developed a sharp pain in her right hip that did not go away. Her menstrual periods became very painful, and she developed a slew of symptoms including fatigue, migraines and joint pain that often kept her from working full time.

“It felt like I had a really severe case of the flu, and those were the good days,” said Ms. Hudak, now 43, who works in sales in Cleveland. “I had years and years of doctors telling me I was crazy.”

Ms. Hudak has filed a $1 million claim against Bayer seeking reimbursement for injuries and lost wages.

Yet many women do well with Essure and recommend it.

“I had it done during my lunch hour, and I ran a half-marathon shortly afterward,” said Cindy Dossett, 54, of Newburgh, Ind.

She required another procedure to curb menstrual bleeding after getting the implant, but over all, she said, “it’s a pretty easy process.”

Essure was the first device to offer women an alternative to tubal ligation (commonly known as having one’s “tubes tied”) and, as such, was considered a game changer, experts said.

The small coils are placed in the fallopian tubes vaginally, without a surgical incision and with minimal anesthesia.

Once inserted, the coils — made of a nickel titanium alloy and a polyesterlike fiber called polyethylene terephthalate, or PET — trigger an inflammatory response, causing scar tissue to form and block the fallopian tubes, preventing sperm from reaching an ovum. The scarring process can take three months, and women must use other contraceptives until testing confirms the tubes are blocked.

But pain and other serious side effects emerged early in clinical trials required for approval.

In a safety trial that enrolled 269 women ages 23 to 45, the device was successfully inserted into 200 patients. In nine of them, a coil perforated the fallopian tube, was expelled or lodged elsewhere in the body, according to a 2003 report in the journal Human Reproduction.

Trial participants were asked to keep diaries, and nearly one in 10 participants recorded painful intercourse, while one in eight had painful menstrual periods during the first three months.

In a subsequent trial of 518 women, only 449  were able to rely on the device. On 21 occasions, the implant perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil.

Participants again reported back pain, abdominal pain and pain with intercourse.

At the time, F.D.A. officials were concerned that the trials had followed women only for a year or two, while the implant was meant to last a lifetime. The agency approved Essure in 2002 on condition that the investigators continue to monitor the women who participated in the trials for four more years.

The F.D.A. said only 171 women in the smaller trial were followed for five years. A heavily redacted report, posted on the F.D.A. website, shows that five women had hysterectomies and that at least one became pregnant.

Participants reported 270 adverse events, including dozens involving pain and heavy menstrual periods. The investigators determined that only 17 of these were caused by Essure and attributed the rest to other factors. They concluded that pain and bleeding were therefore rare among users.

Although the monitoring period ended in 2007, long-term data on women in the larger trial was published only last week in the Journal of Minimally Invasive Gynecology.

Of the original 518 participants, whose average age was 31, only 366 — about 70 percent — were followed for the full five years.

Fifteen women had hysterectomies. The investigators concluded that only two of these major operations were “possibly” related to Essure.

Thirty-eight percent experienced unusually heavy periods on a recurring basis. One in 20 patients had recurrent pelvic pain, one in 15 had recurrent painful periods, nearly one in 25 had recurring pain with intercourse. Investigators said just one had persistent pain, however.

Because there is no other device like Essure on the market, and because Bayer will not say how many American women have it, experts find it difficult to judge whether the risks are disproportionate. Manufacturers are not required to include control groups in clinical trials, as is standard in drug trials, so there is no comparison group.

F.D.A. officials said they were concerned about the coils moving outside the fallopian tubes, but did not believe the device was flawed.

“The agency believes the benefits outweigh the risks in appropriately selected patients who are adequately informed,” said Dr. William Maisel, deputy director for science and chief scientist in the F.D.A.’s Center for Devices and Radiological Health.

Dr. Zampaglione said women who underwent surgical sterilization were also more likely than other women to undergo hysterectomy. A 1998 study of women undergoing surgical sterilization in the 1970s and ’80s also found high rates of subsequent hysterectomies, he said.

The slowly accumulating data and patient reports, however, have made other experts uneasy.

The National Center for Health Research, a nonprofit group, has begun analyzing adverse event reports related to Essure, looking for patterns of complications.

“The fact that 16,000 women with children and a lot of things to do are willing to take the time to talk about this is very, very unusual,” said Diana Zuckerman, president of the group, referring to Mrs. Firmalino’s Facebook page. “I can’t think of another device like this.”

Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, has calculated that nearly one in 10 women with Essure would get pregnant over a 10-year period, a much higher rate than that among women who undergo tubal ligation.

She finds it troubling that the long-term study published last week did not include data on 30 percent of the trial participants.

In clinical trials, she said, “the most common reason patients are lost like this is because they had a problem.”

Physicians familiar with Essure are now deeply divided. Many use it regularly and say they have had tremendous success.

“It’s the best thing out there,” said Dr. Jeffrey Bittner, a gynecologist in Ottumwa, Iowa. “It’s easy, it’s safe, it’s effective — it’s hard to beat. A doctor who doesn’t tell patients that is not being honest.”

Others have become disillusioned.

“When Essure came out, I was very enamored by it and did a lot of Essures all the time, until I started seeing patients come back with problems and referred to me with complications,” said Dr. Mitchell D. Creinin, professor of obstetrics and gynecology at U.C. Davis Health System in Sacramento.

“It’s a great technology. I’m just not sure it’s ready for prime time.”

http://mobile.nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html?_r=2&referrer

Bayer Essure 'birth control' Harm is in the news! Sign Change.org petition, please

Please sign this petition:  https://www.change.org/p/u-s-house-of-representatives-amend-the-biomaterials-access-assurance-act-of-98?utm_campaign=responsive_friend_inviter_chat&utm_medium=facebook&utm_source=share_petition&recruiter=237367236

Metal coils and furious women: The stunning controversy behind an FDA-approved birth control

By Mary Rezac  (FiDA highlight)

Denver, Colo., Feb 20, 2015 / 04:02 am (CNA/EWTN News).- Perforated organs, metal coils lodged in colons, fetal disfigurement due to nickel poisoning. Chronic pain, exhaustion, bouts of depression and suicidal thoughts.

It’s the stuff nightmares are made of. But these are real symptoms that are being blamed on a real medical device, one that is being protected by the FDA. The device, Essure, is a permanent type of birth control in the form of tiny metal coils inserted into women’s fallopian tubes.

But while it’s been on the market since 2002 and has been touted as safe and effective, thousands of people are starting to come forward and question the device, including doctors very familiar with it.

It started out as a standard procedure for Dr. Shawn Tassone, Ob/Gyn. He was inserting Essure coils into a patient. The 10 minute, in-office procedure was supposed to be quick, simple and painless, and it was one he had performed many times before.

“I remember…I put the Essure in, exactly like how you were supposed to, and then as I sat there the tube started to spasm, and it pulled the Essure in,” he told CNA. “It disappeared, it coiled right into the tube.”  

Unsure of how to proceed, he looked at the product manufacturer’s representative, who was in the room with him. The representative told him to just put another coil in the same tube, but Dr. Tassone knew that was against the product’s instructions.  

“I told (the representative) that, and he was like, 'Nah, that’s not necessarily true',” Dr. Tassone said. “And you’re just being told this stuff by these reps who are college graduates, and I’m sure their hearts are in the right place, but they also want you to do the procedure because they get reimbursed more.”

It was through personal experiences with patients, as well as hearing other women’s stories, that Dr. Tassone eventually stopped doing a procedure he’d once been so sure was safe and effective. He said that while he’s not a conspiracy theorist, he does believe there are a large number of women with severe complications from Essure that are not being acknowledged by the medical community at large.

A Facebook group 14,000 strong

A lot of these women can be found on the Facebook group, Essure Problems. Of the 14,000-plus members, the majority are women who share a strange kind of sisterly bond – almost all of them have had Essure, and almost all of them bitterly regret it.  

When the Essure coils are implanted, they are supposed to stay in the fallopian tubes, where they create a chronic infection that will cause scar tissue to form around the coils, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.

Some possible side effects after the Essure insertion procedure are listed on the product’s website and include: “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body.”

Angela Desa-Lynch, an administrator for the Essure Problems group, said the women in the group have experienced these problems to the extreme.

“Whatever they’ve put on the label, multiply it by 200,” she said. “They say chronic pain, or they say mild cramping or abdomen pain, but they don’t tell you that it’s debilitating. They don’t tell you that it’s 'I can’t get out of bed and take care of my kids' kind of pain.”

When Desa-Lynch had her Essure coils in, she said she felt like she had the flu constantly. She was 28 years old, and her youngest son was just three months old.

“My little son…he had no idea the real parent I could be, because I was going through all these health problems,” she said. Desa-Lynch had to have a total hysterectomy to remove the coils, but she said the recovery process didn’t end with the removal.  

“You’re mad,” she said. “This is not what I signed up for. I just wanted a birth control, I didn’t want a life time of health issues, and to remove my woman parts, that’s not ok.”

Watching the posts on the page can be an emotional rollercoaster, Desa-Lynch said. She hears from women who’ve become depressed, suicidal, divorced, bankrupt, or a combination of those things after having complications from Essure.

Moving coils and the difficulty of removal

One of the most horrific complications is device migration, where the coil leaves the tube and becomes lodged in other parts of the body, usually the colon or somewhere in the pelvis. This can cause a blocked colon or other complications.

It can be extremely difficult for women who want to have their Essure coils removed. Many doctors will deny that the Essure is the root of women’s problems, because the clinical trials they’ve seen from the FDA claim the risks of such complications are so low.

Additionally, Medicare and most insurance companies classify Essure removal as “cosmetic,” which further disincentivizes doctors to remove the coils and often puts women who require the removal into personal debt.

“One woman had a coil in her colon, she went from a business owner to bankruptcy” after four surgeries to remove it, Desa-Lynch said.

Physical removal of the coils can also be difficult because they are fragile and may break.

“You have fragments now in your body, and we’ve had women where they come back after removal and they have these masses growing in their abdomen,” Desa-Lynch said. “Your body’s going to try to encapsulate whatever foreign object is there, and now you have all these little cysts growing everywhere.”

Both she and Dr. Tassone said that from what they’ve seen, the only completely safe and secure way to make sure all of Essure is removed is a total hysterectomy.

What happens if you get pregnant with Essure?

Then there are the women who become pregnant while using Essure. No sterilization method is guaranteed to work 100 percent of the time, save for a total hysterectomy with removal of the fallopian tubes. According to Essure’s website, the device is 99 percent effective at preventing pregnancy, but that is with so-called perfect use.

In the real world, doctors may misplace coils or a woman’s tubes can heal or push Essure out. Furthermore, women given Essure are told to use an alternative form of contraception for the first three months following the procedure until a second appointment which checks for proper coil placement – but many women fail to follow through on this step.

Given these margins for error, a recent Yale School of Medicine study estimated 96 of every 1,000 women who undergo hysteroscopic sterilization, or Essure, would get pregnant within 10 years. For laparoscopic tubal ligations (known as 'having your tubes tied'), the pregnancy risks were significantly lower: 24 to 30 pregnancies per 1,000 women.

In an e-mail interview, FDA representative Eric Pahon told CNA that clinical trials of women who became pregnant with Essure showed “no increased risk of neonatal or pregnancy complications, as long as the pregnancy is in the uterus. The FDA will continue to monitor the safety of Essure to make certain.”

What the women of Essure Problems have found is that doctors will not remove the coils even if a woman becomes pregnant. Most will automatically recommend abortion, because they don’t know what to do.

“They don’t know what can happen, because there is nickel in Essure and it can leach, and the device can move and perforate the sack and has done it, so because the doctors don’t know how to treat you, that’s the first thing they ask you to do is to terminate,” Desa-Lynch said.

Should a woman with Essure choose to continue the pregnancy – and many of them do – she risks nickel poisoning and device migration to her baby, and a 55 percent chance of miscarriage, according to the numbers from the Facebook group.

“Your baby isn’t growing”

One Essure pregnancy story stood out to Desa-Lynch as particularly jarring. A young woman in the Facebook group, born and raised as a devout Catholic, became pregnant despite being on Essure. At 24 weeks of pregnancy, the doctors told her: “Your baby is not growing.”

Her baby had gotten nickel poisoning, so the brain wasn’t developing and the limbs weren’t growing properly. The young woman was told her baby at best would be severely deformed at birth, if not completely brain dead.

“When you’re Catholic, abortion is not something that crosses your mind, you just think 'ok, well, we’ll deal with this',” Desa-Lynch said.

However, after the grim diagnosis, the young woman chose abortion. Desa-Lynch said the woman doesn’t even comment on the Facebook page because she is so haunted by her experience, but she’s there, and she watches the comments.

“I can’t imagine being in her position,” Desa-Lynch said. “It puts you in a hard spot. Here you think you’re doing what’s right for you, what’s right for your family, and what’s right for your health, and now you’re facing these situations that you don’t even know how to handle and neither does your doctor, and you have to go against all of your morals and values…I don’t know what I would do.”

“It goes against a lot of women’s morals,” she added, “and women get severely depressed. Someone posted just yesterday that one of her good friend’s daughters had (Essure) put in and she killed herself, because they go to a doctor and they don’t listen to you.”

When the suicidal posts started popping up more frequently, the group administrators decided to set up a buddy system of sorts. They connected women in the group with other women who were close by, so that they’d always have someone they could go to who understood their situation. The administrators watch posts closely and alert the smaller state groups of concerning posts.

“We work collectively and united,” Desa-Lynch said. “It’s amazing to see women pull together the way that they have and fight for each other.”

False data and bad numbers

As a medical device, Essure had a questionable start at best. When it was pre-approved by the FDA in 2002, the FDA used clinical trials from the device manufacturer, the company which would profit from the approval and sales of the device, to determine whether or not it was safe for women.

When asked if this process created a conflict of interest, the FDA responded: “Although the manufacturer may submit any form of evidence to the FDA in an attempt to substantiate the safety and effectiveness of a device, the FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective.”

Desa-Lynch and the administrators of Essure Problems have three full sets of records from the clinical trials that show complaints of abdomen pain in women in the trial being marked off as “unrelated.”

Dr. Tassone has seen the clinical trials, and said there are times when the ages of women with complaints or complications are crossed off and altered in order to better fit the picture the manufacturer wanted to portray.

“The clinical trials that they were basing their information on were falsified, and we’ve brought this to the FDA,” Desa-Lynch said. “They (the FDA) just say, 'upon their investigation they find everything to be safe, they find the benefits to outweigh the risks'.”

In addition, it is basically impossible to track exactly what percentage of women with Essure have experienced severe complications. Although Bayer and the FDA know that 750,000 kits have been sold, there’s no one keeping track of how many women have had the procedure.

Further complicating the numbers is the fact that multiple kits can be used for a single procedure. Dr. Tassone said he’s used up to three kits on a single woman, which happens if coils break before or during insertion.  

“We have over 200 women who’ve had two kits used on them,” said Desa-Lynch of the Essure Problems group, “So it’s kind of hard to give a percentage on bad numbers.”

Protected status and incentives

But despite the thousands of complaints, Essure is classified as a Class III medical device, a category reserved for devices with PMA (premarket approval). These devices are pre-empted, which means people injured by the product cannot collect damages from the manufacturer.

Typically, Class III medical devices are live-saving devices such as heart stints. The idea behind preemption is that by protecting companies from having to pay damages, it encourages them to continue creating better devices that are necessary for saving and sustaining lives.

The only Class III, protected medical devices that do not save or sustain life? Essure coils and breast implants.

“This is part of the problem,” Dr. Tassone explained. “When you are having studies being done by companies who are falling apart (Conceptus was bought out by Bayer), you have an inherent bias. If the (product) is revoked, then this multi-million dollar project was flawed somehow and they lose money.”

“And you see that with other devices, there is a lot of money involved, and the FDA is not doing due diligence, because sometimes the FDA has people on it who are not necessarily getting paid, but who are affiliated with some of the big companies.”

Doctors, too, receive incentives for using Essure. If they meet a certain implantation quota, the manufacturer gives them a $20,000 scope that can be used to perform multiple procedures. Doctors also are often paid to attend Essure trainings and conferences.

But Dr. Tassone said he believes that most doctors originally implanted Essure because they were told, and truly believed, it was a safe and effective procedure.

“We were told in the beginning that it doesn’t cause any pain and the initial studies that came out said that,” he said. “It makes it look like the doctors are getting greedy by putting Essure in because we get more money, but in reality, 99 percent of us actually believed it was a good procedure and was safer for the patients and it worked.”

He said the procedure itself is still considered less risky than a tubal ligation, which is an involved surgery rather than an in-office procedure. Still, Dr. Tassone stopped implanting Essure about a year and a half ago, and he said it usually doesn’t take much to convince his patients to opt for a different procedure.

“The way I counsel my patients now, I send them to what the Facebook group says,” he explained. “Usually I tell them Essure is a foreign body and it’s permanent - most women don’t want that, when you explain it that way.”  

Lawsuits and Erin Brockovich

There are only a few pending lawsuits involving Essure at the moment, Desa-Lynch said, because the PMA act goes all the way up to Congress.

But the Essure Problems Facebook group intends to fight until Essure is off the market and the PMA act is changed. And they just might win, because of a certain famous lawyer that has joined their fight.

“It kind of started as a joke on the form, like, 'Let’s e-mail Erin Brockovich, haha',” Desa-Lynch said. But they did, “and she listened!”

The lawyer, made famous from a 2000 film about her life as a single mother and environmental lawyer, has created a website, http://www.essureprocedure.net/, where women who’ve had Essure can share their stories and where she posts the latest news about the fight against the device.

“That right there kicked off the empowerment, that kicked off the movement of 'Ok, we can do this',” Desa-Lynch said.

Dr. Tassone said he’d like to see more acknowledgement from the medical community of the pain and suffering Essure is causing some women, as well as more transparency from the manufacturers.

“Acknowledgement is the first step,” he said. “Like the company saying, 'Yeah, this is a foreign body and okay, let’s take a look at this.' That would go a million miles for some of these people, that maybe, it’s not all just in their head.”

He also wonders whether a device that caused similar reactions in men would even be on the market.

“If you have a coil and you said you were going to use it in men for vasectomies and you were going to insert it in to block the testicle from having sperm come out, would we be doing that or not? Because they could feel that implant,” he said.

“But with tubes, and in women’s health – because everything is on the inside - I think it’s out of sight, out of mind.”

Until the Essure Problems group can get their case pushed through in court, Desa-Lynch said it’s enough for them to keep informing women and to prevent them from getting Essure.

“We’ve saved over 600!” Desa-Lynch said proudly. “We keep track of them. That right there is enough to know that this is the right thing to do.”

 http://www.catholicnewsagency.com/news/metal-coils-and-furious-women-the-stunning-controversy-behind-an-fda-approved-birth-control-95749/

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Tags: Contraception, Women, Women's Health, Essure, Sterilization