Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, January 5, 2015

ESSURE harmed women speak at FDA on January 14: Please donate!

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The Case Against Essure
Jan 9, 2015 Kevin Pflug
Defective Medical Devices

Normally, when a company sells a defective product, those who have been injured may file lawsuits seeking compensation for the harm they have suffered. For women who have experienced serious medical complications because of the birth control device Essure, the courthouse doors have been closed. A legal doctrine known as federal preemption has prevented injured patients from filing lawsuits against Bayer, the maker of the medical device.
Last year, a woman filed a lawsuit in Philadelphia challenging the application of federal preemption to Essure lawsuits, alleging that the doctrine should no longer apply to Essure. If the case is successful, it could pave the way for other Essure victims to file lawsuits seeking compensation for their injuries.
What Is Federal Preemption and What Does It Mean For Those Harmed by Essure?
Federal preemption is a legal doctrine derived from the Supremacy Clause of the United States Constitution. Under the Supremacy Clause, federal laws may supersede any inconsistent state laws or regulations. For a federal statute to preempt state law, however, Congress must draft the law to specifically state that it preempts state regulation.
While the federal law governing medical devices, the Medical Device Amendments Act of 1976, contains a preemption clause regarding state regulation of medical devices, the preemption provision does not expressly prohibit lawsuits based on state law tort claims, such as negligence or breach of warranty.  
In 2008, the Supreme Court ruled in the case of Riegel v. Medtronic that the preemption provision of the Medical Device Act prevents injured patients from filing lawsuits based on state law claims involving certain medical devices that have received premarket approval from the FDA. Thus, women who have been harmed by Essure have been unable to file lawsuits against Bayer. This prohibition seems particularly unfair and arbitrary, especially in light of the fact that there is no such limitation on lawsuits involving FDA-approved prescription drugs or other types of medical devices that are cleared by the FDA under its 510(k) program.
Following the Supreme Court’s decision in Riegel v. Medtronic, Inc., the New York Times published an editorial titled “No Recourse for the Injured” decrying the Court’s decision, observing that:
Justice Scalia’s faith in the F.D.A. far outstrips our own. The supposedly expert and rigorous reviewers at the F.D.A. are hardly infallible. They may approve marketing of a device based on questionable evidence and they are notoriously derelict about removing dangerous products once they are on the market.
Moreover, the New York Times reported that when Congress passed the Medical Device Amendments Act in 1976, it did not intend for the law to deprive injured patients of their right to sue medical devices makers:
When it passed the 1976 law, Congress almost certainly had no intention of removing the right to sue. Senator Edward Kennedy, the Senate sponsor of the law, and Representative Henry Waxman, who sat on the House panel that approved it, have both said that Congress had no intention of granting the manufacturers immunity from lawsuits over injuries caused by their devices.
Despite criticisms from the New York Times and others, federal preemption of lawsuits involving certain medical devices remains the law of the land. Unless a judge rules that FDA premarket approval of Essure should be invalidated, Essure victims will be unable to seek compensation from Bayer.
Bayer Failed to Report Essure Problems, Misled FDA
Although the Supreme Court’s ruling made it nearly impossible to successfully sue a manufacturer who made a defective product that the FDA approved, the Supreme Court also ruled that a medical device that has received premarket approval must be manufactured and marketed with almost no deviations from the specifications set forth in the FDA approval application.
In May of last year, a Florida woman filed a lawsuit against Bayer alleging that federal preemption should no longer apply to Essure lawsuits because the company misled the FDA about the safety and effectiveness of Essure and created a dubious marketing scheme that gives doctors a financial incentive to push the product on patients.
The lawsuit alleges that the FDA’s Conditional Premarket Approval (“CMPA”) of Essure became invalid because of Bayer’s failure to comply with the terms of the CPMA order. As a result, Bayer’s CPMA is “invalid and its adulterated product, Essure, should never have been marketed or sold.”
Under the FDA’s Premarket Approval Process, devices can either be “approved,” “conditionally approved,” or “not approved.” The FDA conditionally approved Essure, meaning that the device could be marketed and sold in the United States as long as Bayer complied with a specified list of conditions. One of those conditions requires Bayer to report to the FDA whenever it receives information that reasonably suggests that the device may have caused or contributed to a serious injury. In addition, the FDA conditional approval requires that Bayer’s representations and warranties regarding the safety and effectiveness of Essure must at all times be “truthful, accurate, and not misleading.”
According to the lawsuit, the FDA’s conditional premarket approval of Essure is invalid because Bayer has failed to comply with the conditions set forth in the premarket approval of the device by:
  1. Failing to report and actively concealing perforations that occurred as a result of Essure
  2. Erroneously using non-conforming materials in the manufacture of Essure
  3. Manufacturing Essure at an unlicensed facility
As alleged in the lawsuit, Bayer “actively concealed these violations” and had the plaintiff known that Bayer “was concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same, she never would have had Essure implanted.” Failure to comply with just one of the FDA’s conditions could invalidate the CPMA Order.
If the court agrees with the plaintiff’s allegations that Bayer has failed to comply with the FDA’s conditions, the company would no longer be able to claim that Essure lawsuits are preempted by federal law. 
Essure victims may also be able to allege that the FDA’s premarket approval of the device should be invalidated because Conceptus (the company that originally designed Essure and is now owned by Bayer) misled the FDA by failing to report the negative side effects of at least one woman who participated in a clinical trial that the FDA relied upon in approving Essure. The woman who participated in the Essure clinical trial told NBC News that she experienced severe pain that made it difficult to breath and have intercourse; however, the studies that Conceptus submitted to the FDA did not include reports of these adverse reactions. Instead, the company told the FDA that “comfort was rated as good to excellent by 99% of women.”
What Is Essure?
Essure is a permanent birth control device for women. Approved by the FDA in 2002, Essure has been implanted in more than 750,000 women worldwide. Its popularity can be attributed in part to Bayer’s aggressive advertising campaign, which touted the device as “the only non-surgical, permanent birth control available.”
The medical device is a four-centimeter, micro-insert that is placed in the fallopian tubes and prevents pregnancy by causing severe inflammation that is intended to create a total and permanent blockage of the fallopian tubes. Essure’s micro-inserts are comprised of an expanding coil made of a stainless steel inner coil, a nickel Titanium (nitinol) expanding outer coil and polyethylene (PET) fibers. After placement of the coils in the fallopian tubes by Bayer’s disposable delivery system, the micro-inserts expand upon release and anchor into the fallopian tubes. The PET fibers cause inflammation in the fallopian tubes, causing scar tissue to form over the coils, thus blocking fertilization.
On its website, Bayer claims that Essure “works with your body to create a natural barrier against pregnancy.” This statement would be true if your definition of “natural” included the use of plastic fibers to cause severe inflammation and the formation of scar tissue.
Many of the women who experience severe pain after being implanted with Essure may unknowingly be allergic to nickel, a metal used in the device. According to news reports, the FDA originally advised doctors to have their patients undergo a test to determine if they were allergic to nickel before being implanted with Essure, but Conceptus asked the FDA to remove this requirement several years ago. Recent studies have found that ten to twelve percent of women may be allergic to nickel.
Essure Can Cause Serious Medical Complications
Although Bayer claims that serious complications caused by Essure are “rare” and that the device is over “99 percent effective at preventing pregnancy,” these assertions are undermined by the actual experiences of thousands of women across the country who have either experienced debilitating chronic pain or became pregnant after being implanted with Essure. In fact, Bayer’s Essure celebrity spokesperson, Olympic skier and gold medalist Picabo Street, became pregnant after being implanted with Essure. She is no longer a spokesperson for Essure.
Two years after being implanted with Essure, the plaintiff who filed that lawsuit was hospitalized multiple times due to severe pain, fever and fainting spells. Eventually, a CT scan revealed that one of the micro-inserts had migrated from the fallopian tube and became lodged in or behind her colon. It was also discovered that there were three micro-inserts inside the plaintiff (instead of two) because the doctor attempted multiple times to successfully implant the device. The plaintiff eventually underwent a complete hysterectomy and an additional surgery to remove the coil lodged in her colon. According to the lawsuit, she now suffers from several autoimmune and adhesion disorders.
The lawsuit alleges that Bayer did not adequately train the plaintiff’s doctor on how to properly implant Essure. According to the lawsuit, the plaintiff’s physician told her that a representative from Bayer would be present to supervise the procedure. Bayer’s representative allegedly failed to attend and supervise the procedure and it took the implanting physician several attempts to successfully implant Essure in the plaintiff.
Furthermore, the lawsuit alleges that, “the skills needed to place the micro-inserts as recognized by the FDA panel are way beyond the usual gynecologist.” Bayer’s own experts in hysteroscopy (as compared to general gynecologists not on the same level as an expert) allegedly failed to place the micro-inserts in 1 out of 7 clinical participants.
Bayer Gave Doctors Financial Incentive to Push Essure
Doctors who want to implant Essure in patients must have specialized hysteroscopy equipment in their offices to insert the device. As part of Bayer’s Essure marketing program, Bayer provided this hysteroscopy equipment to doctors free of charge. In exchange, the doctors who receive the free equipment must agree to purchase two Essure kits a month from Bayer, regardless of whether he or she has patients that month who actually want the device.
According to the lawsuit, this marketing scheme is an “unreasonably dangerous distribution plan” that was “aimed at capitalizing on and monopolizing the birth control market at the expense of the plaintiff’s safety and well-being.” In addition, the lawsuit alleges that this distribution plan created an environment that “induced the implanting physician to push Essure to patients.”
Essure Victims Organize Online to Raise Awareness
If the court agrees with the plaintiff’s allegations and finds that Bayer has failed to comply with the conditions of the FDA’s premarket approval of Essure, the lawsuit may pave the way for thousands of other women to sue Bayer for their injuries.
In the meantime, thousands of women across the country have turned to social media to raise awareness of the controversy surrounding Essure. For example, a Facebook community page called “Essure Problems” has more than 4,500 likes and the “Essure Uncensored” page on Twitter has nearly 1,500 followers. 
In addition, environmental activist and consumer rights advocate Erin Brockovich has created a website to educate the public about the dangers of Essure. Ms. Brockovich recently appeared on HuffPost Live to speak out against Essure.

According to the Cincinnati Enquirer, Bayer has no comment regarding the social media campaign against Essure. In a thinly-veiled denial, a statement released by Bayer reads: “We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause.”

Undeterred, Essure victims are taking their fight to the FDA. On January 14, several members of the online group Essure Problems will meet with FDA representatives in Washington, D.C. to urge the agency to rethink its approval of Essure. The group is currently seeking donations to fund its trip to Washington.

DONATE HERE!           FiDA highlight

This fundraiser is to help with expenses to send six Essure Problems group administrators to Washington, DC for meetings to address Essure, it's safety and effectiveness, the FDA's role in Essure, and ultimately to impress upon those there that Essure needs to be removed from the market.

$1,712raised of $3,182 goal with 5 days remaining   DONATE HERE!85 donors


by Carrie Hirmer
From admin Amanda Dykeman: 
I just received a call from Ben Fisher, Director, Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation in the FDA.  WE LANDED OUR MEETING IN FRONT OF THE FDA LADIES!! We have 1 hour on the floor in front of the new CDRH ombudsman, staff that has prior experience with essure, and staff from the office of device evaluation and compliance!! On January 14, at 9:30 am tentatively we will finally have our time to shine!!!!  DONATE HERE!
by Carrie Hirmer
With your help, we are almost 1/4 of the way to our goal!  Thank you for your faith and trust in us and for allowing us to be your voices!
We want to show key lawmakers and other decision-makers in DC the issues faced by not only the women with Essure, but also the impact it has on the family unit as a whole.  DONATE HERE!

Your generosity and support has been amazing so far, but we still have a long way to go.  Please continue to support our efforts and share with others you think might be interested in supporting us as well.  We will not rest until the facts about Essure are known and your voices are heard!
The FDA restricts harmed patient access to speak by limiting the number of meetings and locating the meetings far from hotels and public transportation.  These women are risking their health and stretching family finances to fight for something that the government promised to do:  only clear safe and effective medical devices.  Please donate to show your support for their mission.  Any amount will do that.  
Estimate of travel costs
Hotel: $160/night
Flight:  $200 RT
Transportation: $60
Food: $40
Total:  $460/pp per day

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