Spain Bans Bayer Essure Sterilization Coils

Spanish Ministry of Health has called Bayer to withdraw contraceptive Essure

Posted On 20 Dec 2017By : Bioethics Observatory - Institue of Life Sciences UCVComment: 0

After civil proceedings were opened against pharmaceutical company Bayer all over the world because of the higher risks of serious adverse reactions associated with its contraceptives (see HERE), now, under the authority of the Ministry of Health of Spain, has called for pharmaceutical giant Bayer to stop marketing the contraceptive Essure and to withdraw it from the market, ” as it does not have a valid CE marking certificate”. Thus, as a precautionary measure to avoid birth control implant risks, the Spanish Agency for Medicines and Medical Devices (AEMPS) has ordered health centers and professionals who have Essure to stop using it.

The AEMPS note explains that “Essure® is a permanent contraceptive system, designed to be used as a micro-insert to block the Fallopian tubes and that acts mechanically by causing a foreign body reaction that causes blockage of the tube”. It adds that “it is not advisable to remove the device or modify the follow-up guidelines of users.” Suspension of the certificate was effective from 3 August 2017 for a period of 90 days until 2 November 2017. On 4 August, the European Union took the decision to suspend the marketing of these sterilization implants for three months, after the body responsible for renewing the certification required additional elements before reaching a decision (see further information HERE)

Please sign and share this petition! Thank you!

https://www.petition2congress.com/ctas/the-medical-device-safety-act-hr-2164

The Medical Device Safety Act H.R. 2164

440 Messages Sent So Far

The Medical Device Safety Act 2017 H.R. 2164 #MDSA17

The Medical Device Safety Act of 2017 was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.

We are asking for your support of The Medical Device Safety Act 2017, H.R.2164, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are tens of thousands of consumers who have been harmed by, disabled by, or lost a loved one to a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA17

Toxic medical device cartel penetrates government at the highest levels.

 May 13, 2013 by Brian Johnson

J.C. Scott, SVP, government affairs for AdvaMed is named one of the top lobbyists in theBeltway by CEO Update, a publication covering trade councils

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.

Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.

"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."

AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.

His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).

Report doctors with fraudulent medical device investments.

https://oig.hhs.gov/fraud/docs/alertsandbulletins/2013/POD_Special_Fraud_Alert.pdf

Federal regulators: Beware doctors pushing medical devices

March 26, 2013, 4:28 PM

By Russ Britt

The Health and Human Services Inspector General’s office issued a fraud alert Tuesday, warning consumers and medical professionals about physician-owned groups that get kickbacks from medical device companies in exchange for pushing the devices on to patients.

The warning doesn’t name names but says these so-called physician-owned distributorships “produce substantial fraud and abuse risk and pose dangers to patient safety.” In particular, the warning addresses implantable devices used in procedures either at hospitals or ambulatory surgical centers.

Of concern is whether patients get inappropriate medical referrals or recommendations influenced by financial incentives. Such practices violate the Social Security Act, which prohibits doctors to recommend devices for any Medicare or Medicaid program where they would get reimbursed. Further, regulators don’t believe disclosure by the doctor is enough, since it’s often used as an added incentive for patients to use a particular product or facility.

You can read the full warning here.

Follow Russ Britt on Twitter @russbrittmktw

Follow Health Exchange blog on Twitter @MWHealthBlog

Legal crime? Profit trumps patient harm.

http://www.nytimes.com/2012/11/27/business/st-jude-medical-suffers-for-redacting-a-product-name.html

NEWS ANALYSIS

A Name Blacked Out, a Reputation at Risk

By BARRY MEIER  FiDA highlight

Published: November 26, 2012

Peter Muhly for The New York Times

Dr. Ernest Lau holds a Durata lead from a St. Jude Medical Fortify ICD, an implanted heart defibrillator.

                       

IS covering a product’s name in a public document a sign that a company has something to hide? And how should doctors, patients and investors react if the product at issue is one on which peoples’ lives and a company’s fortunes depend?

Such questions now loom over St. Jude Medical after the disclosure last week that its executives had blacked out the name of a heart device component when they released a critical federal report involving the product. The value of St. Jude has since plummeted more than $1 billion, or 12 percent. But the company’s actions may have a more lasting impact on its reputation and the health of patients, some experts say.

Last week’s incident was the latest development in a controversy involving the component, an electrical wire that connects an implanted defibrillator to a patient’s heart. St. Jude officials say the wire, which is known as the Durata, is safe. But uncertainty about the company’s statements is growing, underscored by its handling of the report, which involved a Food and Drug Administration inspection of a plant that makes the Durata.

St. Jude released that report in October as part of a filing with the Securities and Exchange Commission. The F.D.A. provides device makers with the reports in an unaltered form, and they may contain criticisms of a company’s procedures.

But the version of the report that St. Jude filed with the S.E.C. left some doctors and analysts uncertain about which company product or products were at issue for a simple reason — St. Jude had redacted, or blocked out, all 20 references to the Durata in it.

Company executives said they had done so based on their “good faith” interpretation of how the F.D.A. would act if it publicly released the report under the Freedom of Information Act. But both an F.D.A spokeswoman and a lawyer who specializes in medical devices took exception with that view, saying that names of approved products typically do not qualify as the type of confidential business information that the F.D.A. would redact.

Among other things, F.D.A. inspectors found significant flaws in the company’s testing and oversight of the Durata. It was those revelations and the implications that the problems could lead to further F.D.A. action against St. Jude that led to the sharp fall last week in its stock price.

In 2005, Guidant, a device maker that no longer exists, also found itself under scrutiny. Back then, its executives decided not to tell doctors that one of its defibrillators could short-circuit when a patient needed an electrical jolt to save a life. The expert who brought the Guidant problem to light, Dr. Robert Hauser, a heart specialist in Minnesota, has also raised concerns about the St. Jude wires, adding that he believes that its executives have been less than forthright.

“Patients and physicians would appreciate more information,” Dr. Hauser said.

Craig Lassig for The New York Times

Dr. Robert Hauser, a cardiologist who studies heart devices, has raised concerns about wires in defibrillators from St. Jude.

In an earlier interview, St. Jude’s chief executive, Daniel J. Starks, said the company had hidden nothing about the Durata or another heart wire named the Riata, which it stopped selling in 2010.

“We’ve been more transparent than others,” said Mr. Starks, referring to company competitors like Medtronic.

Still, some Wall Street analysts share Dr. Hauser’s view. And if one St. Jude executive can claim credit for shaping their opinion, it would be Mr. Starks.

Earlier this year, he sought, among other things, to have a medical journal retract an article written by Dr. Hauser that was critical of the Riata. The publication refused.

Now, after St. Jude’s latest misfire, Wall Street analysts, who usually agree more than disagree, are placing wildly differing bets on St. Jude, with some valuing it at $48 a share and others at $30. On Monday, St. Jude closed at $31.86 on the New York Stock Exchange.

One of those bearish analysts, Matthew Dodds of Citigroup, said he thought the Food and Drug Administration might act soon on Durata. “I believe that a lot of their actions have made the situation worse, ” he said of the company’s executives.

A St. Jude spokeswoman, Amy Jo Meyer, reiterated the company’s stance that it had interpreted agency rules in “good faith” when releasing the redacted report about the Durata. An F.D.A. spokeswoman, Mary Long, said the agency did not consider the names of approved products to be confidential. And a lawyer, William Vodra, said that while device makers try to make a confidentiality argument for product data they consider embarrassing, like injury reports, they rarely succeed.

“In my experience, the F.D.A. consistently rejects” such arguments, Mr. Vodra wrote in an e-mail.

For patients, the dilemma may become more excruciating. The company’s earlier heart wire, the Riata, has begun failing prematurely in some of the 128,000 patients worldwide who received it. And those patients and their doctors face a difficult decision: whether to leave it in place or have it surgically removed, a procedure that carries significant risks.

St. Jude executives say that the Durata, which uses a different type of insulation than the Riata, is not prone to such problems.

And with the Durata already implanted in 278,000 people, many heart specialists certainly hope they are right.

Mayo Social Media Summit

LINK

Voting for the scholarship is July 16-August 3, 2012.  http://socialmedia.mayoclinic.org/2012/07/16/joleen-c-scholarship-contest-essay/  I will win if you- DAILY - push the 'Like' button for FaceBook, Twitter, and leave a positive comment. Thank you!

My essay:

Login, “Like” Twitter & Post:  When the Medical Device Safety Act is passed by Congress and the Charter of the FDA is amended to include voting Patient Representatives on the medical device panel (as in pharmaceuticals), social media will be able to claim a large part of the victory.

Four years ago I began handling phone, mail and other correspondence for a family member who experienced early failure of a joint replacement implant.  Internet research revealed the medical and legal purgatory of thousands of joint replacement implant patients.  Navigating the medical system (for a disabled person prescribed maximum dose painkiller and living 1,000 miles apart) is challenging but not uncommon situation for many caregivers, I learned.  Because the root of the problem was intractable (poor federal public policy) my role transitioned to unpaid full-time advocate. I applied and was selected in September 2010 to attend the FDA Patient Representative workshop, which expanded my advocacy to all patients with failed implanted medical devices.   

My stated goal is to help patients with failed devices access the medical care that they require and to work toward the conclusions of the Institute of Medicine’s 7/29/2011 report. It advised the FDA to restrict the use of FDA 510(k) approvals for implanted devices and provide a post-market UDI national registry that would be accessible to patients and their medical providers.

This quest prompted me to join with a number of effective advocacy organizations such as The Society for Preventative Medicine, Consumers Union and SpeakerLink.  I created a blog (http://fida-advocate.blogspot.com) and regularly participate on FaceBook, Twitter (@JjrkCh) and LinkedIn.  I have testified twice at FDA/CDRH Town Hall meetings and have traveled from my home in Dallas, TX to Minnesota, Washington, DC -4 times-, San Francisco, CA, Irving & San Antonio & Austin, TX in my role as advocate.  Recently, financial limitations prevented me from attending Regina Holliday’s The Walking Gallery and the HDI Forum in Washington, D.C. (both with registration complete) so I participated virtually on a webinar. 

In my work toward the goal of safer and more effective implant devices I would value and benefit from discussions with trained social media professionals and other advocates.  I wish to elevate my advocacy skills and clarity of purpose so that I capably represent the patients who have been harmed and are often unable to travel or spare time/money for this endeavor.  Exposure to new ideas/attitudes would refresh and enhance my implementation of more targeted social media communications.  My advocacy includes educating the public, the device industry, administrators and legislators about federal public policy and legislative changes that would strengthen patient safety and reduce patient harm. 

I appreciate that Mayo Social Media has many qualified applicants for these three scholarships.  Thank you for your consideration and this valued opportunity to communicate via social media! 

Marketing patient harm: implanted medical devices.

LINK

AP News  Bloomberg Business Week

FDA panel sees little use for metal-on-metal hips

By Matthew Perrone on June 28, 2012  (FiDA blog bold)

           

WASHINGTON (AP) — Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.

"I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.

FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.

If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas.

Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

"The truth is there are different types of hips and different types of patients," said Dr. William Maisel, FDA's chief scientist for devices, in an interview last week. "Understanding the characteristics of patients who experience adverse events is very important."

Women and overweight people are among the groups that are more likely to have an implant failure.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."