Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes

Bayer’s Essure Contraceptive Implant, Now With a Warning

By RONI CARYN RABIN            NOVEMBER 21, 201

Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.

The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.

Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.

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Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.

EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES

“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”

Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.

Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.

F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.

The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.

Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.

“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.

The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.

The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.

Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.

“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.

“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.

Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.

The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”

Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.

The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.

Many doctors who insert the implant do not know how to remove it.

By contrast, drug trials are required to have a comparison group of participants who are given a placebo.

Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.

This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.

The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.

Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.

http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F

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

Profitable Innovations: But Is Your Implanted Medical Device Safe?

http://well.blogs.nytimes.com/2014/03/31/the-device-makers-shortcut/?_php=true&_type=blogs&ref=todayspaper&_r=0

THE CONSUMER

The Device Makers’ Shortcut

By RONI CARYN RABIN MARCH 31, 2014, 4:31 PM 16 Comments

A few years ago, the Food and Drug Administration announced a stunning recall, saying that electrical wires in some St. Jude Medical heart defibrillators, which were implanted in tens of thousands of people, were defective. It was a rerun for cardiac patients: In 2007, Medtronic recalled its Sprint Fidelis cardiac devices because of faulty wires.

In both cases, the F.D.A. warned that the wires could cause painful shocks or fail when needed, and patients were left to choose between living with the leads under close monitoring or having dangerous surgery to replace them. Both companies reported deaths linked to the flawed leads.

Now a new paper by Harvard researchers, using records only recently made available by the F.D.A., explains how the faulty leads got onto the market, shedding light on a little-known process used by manufacturers to alter medical devices without putting them through human trials. (An approval pathway for lower-risk medical devices, called the 510(k) clearance, has received more public scrutiny, including harsh criticism from the Institute of Medicine.)

For so-called high-risk devices like heart defibrillators, the F.D.A. typically requires proof of safety and effectiveness in clinical trials with real patients under real-life conditions. But once such a device receives initial approval, the researchers found, an administrative maneuver permits companies to tinker with it — making the electrical wire thinner, for example — without testing the changes in a single patient.

The process, called a premarket approval supplement application, allows manufacturers to get upgrades and improvements to patients faster, medical device companies say. The application is “intended for a change to an already approved P.M.A. that has met the agency’s rigorous requirements for safety and effectiveness,” said Janet Trunzo, senior executive vice president for technology and regulatory affairs with AdvaMed, a trade association. She noted that the F.D.A. could require a more rigorous review process if necessary.

The problem is that a device can be modified over and over, even dozens of times, without ever being put through new trials in patients. From 1979 and 2012, the researchers found, the F.D.A. approved 77 new cardiac-implanted electronic devices like pacemakers and defibrillators. During that same period, the agency approved nearly 6,000 supplement applications.

A spokesman for Medtronic said the company did test the Sprint Fidelis’s new leads in patients, but the trials were begun in November 2003, around the time the company also filed its supplement applications, and the resulting data were not shared with the F.D.A. before the thinner leads went on the market. The study was published only in 2007, shortly before the recall.

For each device that went through the full premarket approval process, 50 subsequent changes were made, researchers also found.

“Over time, the accumulation of changes may lead to a device that is substantially different than the original product,” said Dr. Aaron S. Kesselheim, senior author of the paper, published in JAMA, the journal of the American Medical Association.

“Most of top-selling devices that are out on the market now have all been approved via supplements for the last 10 years,” he said. They are “substantially different” from the versions originally approved, he said.

While some of the supplement changes were minor, like rewriting instructions or changing the color, 37 percent involved a change to the device’s design, Dr. Kesselheim and his colleagues said. Companies are not required to mention the changes on the package labels, and generally do not.

As a result, doctors are often unaware which version of the device they are implanting, said Dr. Rita Redberg, a cardiologist and professor at University of California, San Francisco, who has written on the topic. “These supplements are not just flying under patients’ radar screens, they’re flying under doctors’ radar screens,” Dr. Redberg said.

The recalled wire in St. Jude’s defibrillator was approved as a supplement to a device whose original design had been approved in 1996 but had undergone 78 supplementary revisions, according to the research. The recalled Sprint Fidelis lead was approved as a supplement to a device originally approved in 1993 and modified 91 times.

“These leads may have worked in the lab, but that is very different from what happens inside a human blood vessel,” Dr. Redberg said. “People move around, they’re very complex, and the lead is going to be exposed to a lot more stress and forces of resistance.”

Clinical trials don’t always find rare complications. But the failure rate in St. Jude’s device was high enough that it would have been noticed in a trial, she said.

The pace of supplements has increased significantly during the past decade, to 704 a year from 77, the researchers found. The last time an implantable cardioverter defibrillator went through a full rigorous premarket approval process was in 2000, the researchers said, “indicating that all models released since then have been supplements” to existing models.

But since a Supreme Court decision in 2008 determined that manufacturers were immune from liability for personal injuries as long as their devices had been approved by the F.D.A., injured patients who want to sue face an uphill battle. Dr. Kesselheim and his colleagues put forth several proposals in their article, suggesting the F.D.A. convene a panel of experts to review approved medical devices every five to seven years and determine whether the clinical data from the older models still applied to the newer versions.

But the agency appears to have rejected the idea. An automatic advisory panel review is not “a necessary or efficient use of F.D.A. or taxpayer resources,” said Susan Laine, a spokeswoman.

 FiDA comment

The JAMA article concludes by highlighting the importance of rigorous post-market data gathering to bolster the FDA assurance of ‘safe and effective’.  This could be done by PCORI (Patient Centered Outcome Research Institute) which is a new government non-profit agency commissioned and funded by Congress.  However, though the omission of implanted medical device patient outcomes research has been demanded by harmed patient and patient advocates, PCORI has resolutely avoided this responsibility.  http://www.americanprogress.org/events/2014/01/16/82429/high-priced-drugs-and-medical-devices/

http://www.investigatorawards.org/investigators/aaron-kesselheim

Aaron Seth Kesselheim M.D., J.D., M.P.H.

Assistant Professor

Department of Medicine

Harvard Medical School

Email: akesselheim@partners.org

Discipline: Medicine, Drug Development, Law

Investigator Award

Sources of Transformative Innovation in Medication Development

Award Year: 2009

How can the engine of pharmaceutical innovation in the United States, sluggish now despite substantial investment, be jump-started again? Whether the right pathway involves increased government support of basic research or a transformation of industry product development and clinical trial work, patent law will play a key role. Aaron S. Kesselheim, M.D., J.D., M.P.H., explores a number of questions related to this issue, including how basic, translational, and product-development research combine to create breakthrough drugs and how patent-based incentives facilitate or impede drug development. His project, Sources of Transformative Innovation in Medication Development, will identify the most transformative drugs that have emerged in the past 25 years, examine their scientific origins, and assess the intellectual, social, and financial factors that influenced their development. Dr. Kesselheim also will analyze whether patents have rewarded the most important contributors to new pharmaceutical breakthrough products and test an alternative to the current patent system. His project addresses whether new legal or resource-allocation strategies are needed to reinvigorate pharmaceutical innovation and how possible reforms might encourage drug development, apportion rewards more appropriately, and help contain research costs.

Background

Aaron S. Kesselheim is an assistant professor of medicine at Harvard Medical School, based in the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women?s Hospital (BWH). He graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is board-certified in internal medicine, serves as a primary care physician, and attends on the general medicine inpatient service at BWH. He is a member of the New York State Bar and is a patent attorney. His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. He received a career development award from the Agency for Healthcare Research and Quality to study comparative evidence, regulation, and trends related to prescribing off-label drugs. He has contributed commissioned works on market-based incentives for pharmaceutical R&D to the Institute of Medicine and the Robert Wood Johnson Public Health Law Research Program. He has also investigated other issues at the intersection of law and public health, including health care fraud, expert testimony in malpractice cases, and insurance reimbursement practices. His numerous articles and book chapters related to these topics have appeared in leading medical and health policy journals, including the New England Journal of Medicine, JAMA, and Health Affairs. In 2010, he received the Alice S. Hersh New Investigator Award from AcademyHealth, the main professional organization for health services/policy research. The Hersh award is given annually to an outstanding health services researcher under age 40 in the U.S. In addition to his research, Dr. Kesselheim has taught on law and public health issues at Harvard Medical School, Law School, and the School of Public Health. He has testified before the U.S. House of Representatives and addressed different state legislatures on drug policy matters, and he has consulted for the federal government?s clinical trials registration website (ClinicalTrials.gov). He has also served as an ad hoc peer reviewer for numerous medical and scientific journals (earning a commendation for his work from Annals of Internal Medicine in 2009), the Harvard Law Review, and the London School of Economics.

1.       BOOK CHAPTERS

2.       SELECTED JOURNAL ARTICLES

                  Kesselheim, A.S. Innovation and the Orphan Drug Act, 1983-2009: Regulatory and Clinical Characteristics of Approved Orphan Drugs, In Rare Diseases and Orphan Products: Accelerating Research and Development, eds. Field, M.J., Boat, T.F. Washington, DC: N

http://www.sciencedaily.com/releases/2014/01/140121164748.htm

Featured Research

from universities, journals, and other organizations

Many cardiac devices approved by process that often does not require new clinical data

Date:

January 21, 2014

Source:

The JAMA Network Journals

Summary:

Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according to a study.

Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according to a study in the January 22/29 issue of JAMA.

"In the United States, the Food and Drug Administration (FDA) reviews high-risk medical devices -- those that support human life, prevent illness, or present an unreasonable risk -- via the premarket approval (PMA) pathway, through which manufacturers collect preclinical and clinical data as necessary to provide 'reasonable assurance' of the device's safety and effectiveness," according to background information in the article. That process has attracted attention in recent years after recall of device components, like leads from Medtronic Sprint Fidelis and St. Jude Medical Riata implantable cardioverter-defibrillators (ICDs), that were not tested clinically in human trials prior to approval because they were design changes to prior-marketed devices and considered 'supplements' to PMA applications submitted almost a decade earlier.

The process of approval by premarket approval supplement "allow[s] patients to benefit from incremental innovation in device technology by providing efficient and inexpensive FDA review pathways for smaller device changes. Supplements may include major or minor design changes as well as routine changes in labeling, materials, or packaging. By statute, the FDA must seek only the 'least burdensome' supporting data necessary for review."

Benjamin N. Rome, B.A., of Harvard Medical School and Brigham and Women's Hospital, Boston, and colleagues used the FDA's PMA database to review CIEDs (including pacemakers, ICDs, and cardiac resynchronization therapy [CRT] devices) approved as PMA supplements from 1979 through 2012. They identified the number of supplements to each original PMA and characterized the nature of the changes in each supplement.

Seventy-seven approved PMA applications for CIEDs (46 pacemaker devices, 19 ICDs, and 12 CRT devices) were the basis for 5,829 PMA supplement applications, with a median (midpoint) of 50 supplements per original PMA. In the last decade, the number of approved supplements annually increased to 704. Excluding manufacturing changes that do not alter device design, the number of supplements approved each year averaged 2.6 per PMA per year.

Thirty-seven percent of supplements represented at least minor alterations to the device's design or materials. Among 180-day supplements (a type of FDA review process) approved between 2010 and 2012, 23 percent included new clinical data to support safety and effectiveness.

"… Our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness," the authors conclude. However, clinicians and patients should … be aware … that clinical data are rarely collected as part of PMA supplement applications prior to marketing. The recalled Medtronic Sprint Fidelis and St. Jude Riata ICD leads were both PMA supplements -- Fidelis a 180-day supplement and Riata a real-time supplement [a type of FDA review process]. Neither lead was studied in human trials prior to FDA approval. The FDA's approval of many supplements without new human trials, as in the case of these recent ICD changes, highlights the importance of collecting rigorous postapproval performance data," the authors write.

Story Source:

The above story is based on materials provided by The JAMA Network Journals. Note: Materials may be edited for content and length.

Journal Reference:

Benjamin N. Rome, Daniel B. Kramer, Aaron S. Kesselheim. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012. JAMA, 2014; 311 (4): 385 DOI: 10.1001/jama.2013.284986

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The JAMA Network Journals. "Many cardiac devices approved by process that often does not require new clinical data." ScienceDaily. ScienceDaily, 21 January 2014. <www.sciencedaily.com/releases/2014/01/140121164748.htm>.