Get an Unsafe, Ineffective Medical Implant & Lose Your Civil Rights!

DeLauro Pushes to Protect Consumers from Unsafe Medical Devices

September 26, 2017 Press Release

WASHINGTON, DC (September 26, 2017) —Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).

”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.

“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”

“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”

DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.

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

Birth-control device under FDA review

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

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

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

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

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

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

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

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

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

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

Varying experiences

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

‘E-Sisters’ ranks grow

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More scientific rigor picking out a garbage disposal!

http://ctwatchdog.com/health/more-women-need-to-be-involved-in-medical-device-trials

More Women Need To Be Involved In Medical Device Trials

June 8, 2012

By Ct Health I Team

Written by Rochelle Green  (FiDA blog bold added)

Hundreds of thousands of women at risk for irregular heart rhythms have a battery-powered, iPod-sized gadget embedded in their chests. The implantable cardioverter defibrillator (ICD) can be a lifesaver, shocking a dangerously fast heartbeat back to normal.Yet the actual benefit to women is uncertain, because ICDs were approved by the Food and Drug Administration (FDA) based on clinical trials made up mostly of men.  That’s typical of testing of many high-risk devices, according to medical reports. And even in the clinical device trials that do include women, generally the outcomes aren’t reported by sex.

The result is a critical gap in the data doctors rely on when making decisions about a treatment’s benefits and risks for women. It can also pose troubling dilemmas later on, said cardiologist Rita F. Redberg, a professor of medicine at the University of California, San Francisco. That was the case in 2009, when data pooled from clinical trials showed that ICDs were no better than drugs at reducing a woman’s risk of death.

“The time to collect data in both sexes is before FDA approval,” said Redberg. “Especially with implanted devices, where there’s no going back.”

Only recently has the FDA proposed guidelines to improve the representation of women in clinical device trials. Intended for the medical device industry, which sponsors most of the research submitted for review, the guidelines are expected to become final by year’s end. Similar standards for drug testing were put in place some 20 years ago, following a long period during which women of childbearing age were explicitly excluded from most studies.

The proposed FDA guidelines are nonbinding, however, and some experts who favor the new recommendations are skeptical that the medical device industry will comply.

“Industry is always most attentive to the bottom line,” said Christine Carter, vice president for scientific affairs at the Society for Women’s Health Research (SWHR) in Washington, D.C. “So companies will continue to lament that trials are expensive and that recruiting more women is a problem.” Device makers will change their study protocols just enough to meet FDA requirements, Carter predicted, but protocols will be “less than ideal for those of us concerned with sex differences and women’s health.”

SWHR and other groups have urged the FDA to strengthen the document by finalizing it as a rule. The debate highlights the competing interests that the agency struggles to balance, with industry and some lawmakers in one camp, demanding faster approvals and “less burdensome” regulation, and health advocates in another, warning that patient safety is at risk.

To U.S. Rep. Rosa DeLauro, the issue is science, not politics. “We know there are real medical distinctions between genders that must be recognized when the government is deciding whether to approve a new device,” she said.

Opening A Window On Women’s Health

Until the mid-1980s, clinical trials were practically a men’s only club. Studies funded by the National Institutes of Health (NIH) and pharmaceutical firms—the largest contributors to biomedical research in the United States—drew subjects primarily from a pool of white males. The first randomized trial using estrogen to prevent heart disease consisted entirely—and counter-intuitively—of men.

Women were considered too complicated to study, given their cycling hormones and the chance that those of childbearing age could expose a fetus to unintended risk, said SWHR’s Carter. Gender wasn’t yet recognized as a factor in health and illness, and it was assumed that study results in men would be just as useful for women.

As biomedical research advanced, however, women began to suspect that their health needs were being left behind, experts say. The results of clinical trials in men weren’t always extended to women, depriving them of powerful new treatments like cholesterol-lowering drugs, according to an Institute of Medicine report. And the male model didn’t always correspond to women’s experience of health and disease.

In the early 90s, women’s health advocates began to mobilize, according to Carolyn Mazure, director of Women’s Health Research at Yale. “They took it to Congress,” she said, educating key legislators about the exclusion of women from medical research and the lack of information about gender differences related to health.

In 1993, Congress passed legislation requiring that women and minorities be included in all NIH clinical research. The FDA reversed its policy barring women of childbearing age from certain drug studies, encouraging their inclusion in all clinical drug trials. The measures also required study results to be analyzed by sex.

As an NIH researcher at the time, Mazure witnessed history in the making. “The idea that we now needed to include women and minorities in our research—we found it revolutionary,” she recalled. Her program at Yale promotes research on gender differences in health by providing seed money to get innovative projects off the ground.

In the past 20 years, scientists have discovered that sex differences are significant at every stage of life and at every biological level, from the single cell to the whole body. Gender influences how people experience disease, metabolize drugs, respond to pain, and much more. While the findings support the need for sex-based research, the going is slow, said Carter.

“There’s still only 30 percent—maybe up to 40 percent—of women involved in clinical trials, and too often their data isn’t analyzed separately from men’s,” she said.

A major challenge is changing the mindset of researchers, she said.  She described how, at a recent SWHR roundtable with more than a dozen Alzheimer’s disease experts, she had asked about the sex differences they had found in their research. Almost all responded that they hadn’t looked at the data that way.

“We’re finding this over and over, with experts in different fields,” she noted. “If you’re not aware that there are biological differences between the sexes, you don’t look for it in your data.” With each roundtable, however, she convinces more scientists to look at outcomes based on sex. “It’s time to make this more mainstream,” she said.

In the meantime, the effects of the old mindset are still in evidence: in one example, women account for just 30 percent of subjects in the clinical trials supporting the American Heart Association’s 2007 guidelines for cardiovascular disease prevention in women. Twenty of the 156 studies were men-only, according to a published gender analysis of the studies from which the guidelines were drawn.

The paucity of women “wasn’t a big surprise,” said Dr. Chiara Melloni, assistant professor of medicine at the Duke Clinical Research Institute in Durham and lead author of the analysis. But it’s a reminder to design studies with gender differences in mind, she said.

Bringing Device Studies Up To Speed

If the FDA’s device center has been slow to tackle the gender gap, its new guidelines are a prescription for change, agency officials say.

In a key provision, researchers are advised that men and women should be enrolled in proportions that reflect the gender distribution of the underlying disease. Cardiovascular device studies, for example, should enroll men and women in equal numbers, since each sex is equally at risk for the disease. Until now, most such studies have included just half as many women as men, according to an FDA review of cardiovascular devices approved in a recent five-year period.

Since medical device studies have traditionally been small, the new enrollment goals will likely require more women, and possibly bump up the number of subjects overall. The guidelines provide strategies for recruiting female subjects, and advice on examining data for potential differences by sex. And they call for sex-specific outcomes to be reported on device labels, a practice that consumer health groups have been advocating for years.

In practice, the vast majority of medical devices reviewed by the FDA are cleared for use without human testing, if they are deemed “substantially equivalent” to devices already on the market. Only 1 percent of devices undergo rigorous review and clinical trials before they can be marketed.

Even so, the new guidelines for device trials are an important advance, experts say. Dr. Patrice Desvigne-Nickens, a program director at the National Heart, Lung, and Blood Institute, praised the FDA for alerting device makers to the new imperative in clinical research. “To not look for gender differences is unacceptable,” she said.

Joleen Chambers on June 11, 2012 at 4:14 pm

Thank you for this excellent and informative article. Sadly, if a woman researches any implanted medical device she will find that data is hidden behind a barrier of “proprietary” claims by the industry. She is more likely to find hard data about any kitchen appliance than an implanted medical device. Gender clinical studies are another layer of insufficient scientific rigor.