Could One Company Be . . . Medtronic? St. Jude?

Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years

By FRED SCHULTE and CHRISTINA JEWETT   OCT. 2, 2017  The New York Times

WASHINGTON — Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of patients.

A report released on Monday by the inspector general’s office for Health and Human Services said officials needed to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the inspector general’s office said.

The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.

Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.

The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It did not outline specific injuries that patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that had either been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.

How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.

The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, like serial and batch numbers, during the billing process.

“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report said.

David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said that medical device recalls nearly doubled from 2003 through 2012 and noted that they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the inspector general’s office. In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.

Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products in patients.

“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.

Ms. Zuckerman noted that the report did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh.

Medical device companies and some doctors have opposed tighter reporting, arguing that it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.

“It is abundantly clear that data collected in electronic health records is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.

Mr. Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.

A spokesman for the Centers for Medicare and Medicaid Services said the agency had not seen the report and would have no comment.

But in written remarks included in the report, Seema Verma, the agency’s administrator, said the tighter reporting requirement was “under consideration” and that the agency would “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”

This article was produced in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation. 

• https://www.nytimes.com/2017/10/02/health/heart-devices-medicare.html?_r=0

Take Action Now! Tell Congress NO on 21st Century Cures bill.

Congress is working on a bill called 21^st Century Cures that would lower the standards for approving drugs and medical devices.  They say it will benefit patients, but it was written primarily by industry.  Unfortunately, a key vote will be tomorrow  morning 5/19/2015!

The National Center for Health Research has drafted a letter to the House of Representatives for individuals to sign with their name and city/state/zip code.  Please spread the word to friends and relatives that care about safe medical products!   

I can’t emphasize enough how important it is that Congress hear from as many individuals as possible NOW!

Diana Zuckerman, Ph.D.
President

National Center for Health Research

Cancer Prevention and Treatment Fund

1001 Connecticut Ave, NW, Ste. 1100

Washington, DC 20036

(202) 223-4000

www.center4research.org

www.stopcancerfund.org

NCHR Twitter / NCHR Facebook

CONSUMER VERSION

Dear Representative XXX,

As patients and consumers from across the country, we are writing to share our very strong opposition to several sections of the 21^st Century Cures legislation.  A few of the issues of particular concern to us follow.  We are not lobbyists, we are American taxpayers, and we hope you will improve the bill to better reflect the needs of regular people like us. 

Subtitle D: Modern Clinical Design, Section 2062 and 2063

FDA standards have developed over the last 100 years so that Americans could trust that medical products are proven safe and effective in scientific studies on humans.  Randomized clinical trials are the gold standard to make sure that a new drug, device, or vaccine is safe and effective.  This section encourages the FDA to lower its standards to even include anecdotes that the bill calls “clinical experience.”  Please remember that clinical experience resulted in tragedies such as thalidomide and the Dalkon shield.  

Whether the FDA is reviewing a drug for a new use, for long-term studies after a drug is already approved, or for a new drug, the FDA should compare the drug to make sure its benefits are greater than its risks for most patients.  That means it needs to be studied on hundreds of men and women, of different ages and different races.  

In medicine, physicians are looking for “evidence-based medicine” not the opinions of a few doctors.  That’s why this section is so dangerous for patients: it would allow the use of individual experiences or summaries of studies (instead of the details of the studies)

 Sections 2121: Approval of Drugs for a Limited Population of Patients

We all worry about antibiotic resistance, but this section tries and fails to address it.  It discourages the FDA from relying on randomized clinical trials that evaluate the impact of a drug on real patients, and instead encourages the FDA to rely on preliminary data.  That might be justifies for patients who would otherwise die without an experimental drug, but unfortunately there is no way for the FDA to prevent these drugs from being promoted and prescribed for all patients.  Millions of patients could die as a result.

4.      Section 2123: Encouraging the Development and Use of New Antimicrobial drugs

This section would pay a bonus to hospitals to prescribe new antibiotics and anti-fungals.  But, these drugs should be used only when needed, to preserve their effectiveness as long as possible.  Many frail elderly patients are put on antibiotics whenever they get sick, in order to prevent pneumonia.  If Congress encourages hospitals to prescribe these new drugs, it encourages overuse and inappropriate use.  The result: fewer effective antibiotics and a Medicare system that goes broke even sooner than many have predicted.

5. Subtitle L, M, and N:  Medical Devices:  

FDA standards for medical devices are lower than for drugs, resulting in patients harmed from artificial hips, unsafe stents, contact lens solution, surgical mesh, and many other common devices.  The device sections in this proposed legislation would lower the standards even more.  How does that make sense? 

Section 2221, Third-party Assessment:  When a company wants to make changes to a medical device that is already on the market, FDA scientists should decide if the changes will change the safety and effectiveness of that product.  Companies should not be allowed to choose to pay a 3^rd party to decide if FDA needs to review those changes.  That is just common sense.

Section 2222,  Medical Device Approvals: This section lowers the standards FDA uses to approve high-risk medical devices such as heart, brain, and spinal implants.  It would allow approval based on case studies, which include only one or two patients.  But the experience of a small number of patients is not necessarily typical of what will happen to most patients, especially patients of the opposite sex or different age.  It would also allow evidence from peer reviewed medical journals instead of evidence from the actual patient data.  Unfortunately, studies in medical journals can be inaccurate, incomplete, or biased.

Health Software: Electronic medical records and other health software help doctors make medical decisions about their patients.  That’s why it is important that the software works well and won’t crash when the patients’ lives are at stake.  FDA should evaluate these devices at least as carefully as they evaluate hip and knee implants, for example.

6.   Section 3041:  Reducing Transparency in the Sunshine Act for Physicians Payments

We are glad that Congress previously required companies to make public their payments to physicians.  That law helps patients know if their doctors have a financial relationship with a company that makes a drug or device that the physician is recommending.  So we are very disappointed that Congress has already proposed a loophole for fees or gifts to doctors that are intended for “continuing medical education” purposes at fancy resorts or other meetings. It also would exempt expensive gifts such as medical textbooks and journals. Although we want doctors to be up-to-date in their education, we believe doctors make enough money to buy these themselves.  

As patients and consumers from across the country, we ask you to pause before passing this bill.  You’re moving too fast on a law that will affect every single person in this country.  We deserve a better bill and a more careful review of the fine print that could save lives if done correctly, and cost many lives if it isn’t very carefully evaluated and revised.

Sincerely,

Conflicted FDA DEFENDS illegal Olympus, device, that killed 2

FDA: Manufacturer never had permission to sell device connected to superbug deaths

By Elizabeth Cohen, CNN Senior Medical Correspondent

Updated 1:04 AM ET, Wed March 4, 2015

Story highlights

1. FDA official says Olympus never got permission to sell its endoscope
2. Medical device is connected to CRE outbreak in California that's left two people dead

(CNN)CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration.

Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs.

"Why didn't we notice it? I don't know," Riley said.

1. Just Watched
   Hospital's $1 solution to clean $30,000 superbug scope

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Hospital's $1 solution to clean $30,000 superbug scope 02:18

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"Can you imagine a prescription drug getting out on the market that didn't go through the approval process?" asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who's testified to Congress about device safety problems. "Devices need to be regulated more vigorously. This is really disturbing."

Mark Miller, a spokesman for Olympus, did not respond to calls and emails from CNN seeking comment for this story.

Outbreak started at UCLA

Seven hospital patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug CRE -- also known as carbapenem-resistant Enterobacteriaceae -- between October and January, according to hospital officials. Two of those patients died.

The patients caught CRE after routine endoscopic treatments. Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak.

The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria.

In a separate outbreak on the other side of the country, 18 people contracted CRE in North Carolina, and one of those died.

Not safer

According to FDA rules, a manufacturer must seek clearance for a new model if it includes changes that "could significantly affect the safety or effectiveness of the device."

The TJF-Q180V duodenoscope, used to check out ducts in the gastrointestinal system, includes a modification to the exact part of the device that's been implicated in the superbug outbreaks.

With this new model, Olympus sealed up that part of the device, known as the elevator channel, hoping to make it more impervious to infection.

"The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," Riley said.

Last year, at the FDA's request, Olympus applied for permission to sell the scope. That application is still pending.

Riley emphasized that duodenoscope procedures can be lifesaving, so the agency doesn't want to take them off the market.

"More than 500,000 of these procedures are done every year in the U.S., and the risk of bacterial transmission is actually really very, very low," she said. "We believe the risks outweigh the benefits."

Riley noted that the other two duodenoscope manufacturers, Pentax and Fujifilm, did apply for and were granted clearance to market models similar to Olympus' TJF-Q180V.

Not clean enough

Now the FDA is asking all three companies to submit evidence that the scopes can be thoroughly cleaned -- and so far it's not going well.

Riley said twice the companies have submitted data that failed to show that cleaning could get rid of 99.9999% of all microbes on the scope -- the FDA's standard for disinfection.

"We're still working with them to get good data," she said.

Riley said she doesn't know if the FDA will penalize Olympus for selling the device without permission.

Diana Zuckerman, a device safety expert (National Center for Health Research), said they should.

"It's like with kids. How do you teach your children to behave if there are no consequences when they misbehave?" she said.

http://www.cnn.com/2015/03/04/us/superbug-endoscope-no-permission/

Essure: Hazardous Birth Control Implant?

Warning: This Birth Control ProductMay Be Hazardous to Your Health

Posted: 11/19/2013 1:36 pm

 by guest blogger Diana Zuckerman, PhD, president of the National Research Center for Women & Families

"Was I just unlucky, or is this medical product not really safe?" That's a question I get asked often, and was recently asked about Essure, a "permanent birth control" device made by Bayer.

At first it seemed these women were just unlucky. But after gathering more information, it now looks like there could be much greater risks than patients are being advised of.

In case you're wondering, permanent birth control means sterilization. The purpose of Essure is to prevent a woman from ever getting pregnant again. For some women, preventing any future pregnancies could save their lives. So it is obviously a problem when Essure doesn't work and women get pregnant, which was one of the problems I heard about. But I also heard from women who were in terrible, unrelenting pain, feeling that their lives had been ruined by this product.

Since National Research Center for Women and Families is known as an objective source of medical information and isn't on the payroll of any companies, the women asked, "What do you know?" and "Is this product really safe, or are there a lot of other women like me?" And also, "Can you warn other women?"

The Food and Drug Administration (FDA) has much lower standards for medical implants than it does for prescription drugs, so I checked out Essure on the FDA website and was pleasantly surprised to see that the FDA had required clinical trials, which the agency often doesn't require for implants. These studies of women with Essure implants showed that Essure patients had a rather low rate of complications.

The studies showed that the main problem was that sometimes the device fell out. If the woman didn't realize it, she could get pregnant. If she did realize it, she'd need to get a replacement implant or use another type of birth control.

There was about a 5 percent rate of serious complications reported--not great (especially if a complication happens to somebody we care about), but not a bad rate, either. Since all birth control has some risks (such as potentially fatal blood clots), and since pregnancy has rather substantial health risks (an even greater risk of potentially fatal blood clots), the studies of Essure seemed reassuring (no pun intended).

Sometimes studies can be deceiving, however, especially when conducted by the company trying to sell you the product. An NBC news investigative team interviewed Kim Hudak, one of the women in the study who has had terrible pain in the years since she got Essure. The reporters found that the telephone surveys and medical visits that were used to provide data for the company's study had yielded information about her terrible health problems after Essure but hadn't counted them as complications. The health professionals conducting the study had made very subjective decisions: for example, that excruciating pain in the same part of her body as the Essure device somehow was unrelated to Essure and therefore needn't be counted as a complication. Instead, they reported Kim's experience with Essure as "excellent" and Kim as "very satisfied." Meanwhile, Kim was in excruciating pain--and had gained 100 pounds from the medications she was given as doctors tried to figure out what was wrong. Kim told me that she thought her health problems might possibly be caused by Essure but believed the doctor when he told her they weren't.

Eventually, Kim was in so much pain that she ignored the doctor's advice and had her Essure implant removed. Kim told me that her health has dramatically improved ever since, and she has lost most of the weight she had gained.

This is not the story of one woman. It's a story about how poorly conducted research provides inaccurate information that can potentially harm thousands if not millions of patients. Whether the study was intentionally fraudulent or just badly conducted by some of the medical professionals involved, the results are the same for Kim and anyone misled by the completely inaccurate reporting of her terrible medical problems. The fact that Bayer was accused just two years ago of covering up deaths from Yasmin, another one of its birth control products, does add extra drama. Can the company's studies be trusted? And should the FDA do a better job of scrutinizing them?

It doesn't take much to monitor these studies. For example, you can see in Kim's study survey where her health problems were clearly written and then somebody crossed them out, added his or her initials to show this was an official revision, and changed the answer from "Yes" (I have health problems since getting Essure) to "No." The woman interviewing Kim also checked "excellent" and "very satisfied."

If that had only happened to Kim and nobody else, then perhaps Essure could be almost as safe as the company reported. But the same people who collected data on Kim also "studied" other women, so it's likely that such changes and inaccuracies happened numerous times. That would mean that FDA's decision to approve Essure was based on inaccurate information.

Instead of monitoring the company's studies, unfortunately, the FDA has defended them. While the NBC investigative reporters were gathering information, the FDA wrote a new article for its website defending the safety of Essure.

As a person who uses medical products, what can you do to make sure you aren't harmed by implants or medications that aren't really safe? There is no easy answer. But there are a few things you can do:

.                Before starting a new medication or agreeing to a new medical implant or device, go online. Go to your favorite search engine and type in the name of the product and the word "problems" or "risks" or "complications." That will usually take you to web pages that list the possible problems with the product. You can even go to the official website for the product. Although a company's website will advertise how great the product is, by law the company is also required to list all the possible complications that the FDA has found. This isn't a perfect source of information (as my Essure example shows), but it will provide some warnings of what the risks are.

.                For prescription drugs, you can also go the ConsumerReport.org's Best Buy Drugs website to get information that compares the drug you are considering with other drugs that can be used for the same purpose. The site doesn't have information about all drugs, but it does have good comparison information about many widely used drugs.

.                Check out www.center4research.org and www.stopcancerfund.org for information about many drugs and devices. And, if you are having trouble finding the information you're looking for, you can contact our Center's free hotline at info@center4research.org to ask us. You'll receive a free, personal response within days.

One more thing to remember: The newest medical products are often not the best, even though they're the most expensive. FDA approves new medical products on the basis of information that is provided by the company making the product. It isn't until the product has been used by many thousands of patients in the real world that it's possible to learn what all the risks are and how it compares to other treatments.

Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals as well as in newspapers across the country.

'Flawed from legislative foundation': FDA June 13, 2013

510(k) Device Modifications: DecidingWhen to Submit a 510(k) for a Change to an Existing Device, June 13, 2013

The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting. FDA also seeks actual examples of device modifications that industry has made in order to help the Agency develop its policy. FDA expects to discuss the following options:

1.             Potential use of risk management in 510(k) device modifications decisions – can FDA incorporate risk management into its policy on how to determine whether device modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff?

2.             Potential reliance on design controls activities – FDA seeks proposals for how industry and FDA could utilize design control activities such as design verification and validation to ensure that device modifications are appropriately evaluated prior to marketing.

3.             Potential use of critical specifications – FDA seeks proposals on whether it could incorporate the use of critical specifications in its policy on how to determine whether devices modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff.

4.             Potential risk-based stratification of medical devices for 510(k) modification purposes – FDA seeks input on the practicality of stratifying devices that require 510(k)s by risk, where lower risk devices would not require 510(k)s for most modifications, if those modifications are part of periodic reports submitted to the Agency.

5.             Potential periodic reporting – FDA seeks comments on the possibility of requiring periodic reporting for legally marketed 510(k) devices.

6.             Potential other solutions – FDA seeks comments on combinations of the options above, or other options not mentioned here.

Date, Time and Location

This meeting will be held on June 13, 2013 beginning at 9 a.m at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room), 
Silver Spring, MD, 20993

•                FDA Campus Information

This public meeting will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on May 30, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after May 31, 2013.  If you have never attended a Connect Pro event, test your connection.  A quick overview of the Connect Pro program is also available.

Preliminary Agenda (All times are tentative)

Time	Subject
9:00 AM	Introduction
9:15 AM	FDA Presentation
10:00 AM	External Stakeholder Presentations
11:00 AM	Break
11:15 AM	External Stakeholder Presentations, continued
12:15 PM	Lunch
1:15 PM	External Stakeholder Presentations, continued
2:15 PM	Break
2:30 PM	Panel Discussion
3:45 PM	Open Comment Period
4:15 PM	FDA Close-out
4:30 PM	Adjournment

Registration to Attend the Meeting

If you wish to attend this meeting, you must register by close of business on Thursday, May 30, 2013.  

There is no fee to register for the meeting and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.

Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the meeting topics.  FDA would like to receive these comments by May 30, 2013, so they can be discussed during the meeting, however, comments related to this meeting will be accepted until July 13, 2013.

Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov.

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the topics defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 3, 2013.  If selected for presentation, any presentation materials must be emailed to Michael Ryan, Michael.ryan@fda.hhs.gov no later than June 6, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting.

Workshop Details

Food and Beverages will be available for purchase during the breaks.

If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Joyce Raines,Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, joyce.raines@fda.hhs.gov.

Contact Us

For questions regarding meeting content please contact:

Michael J. Ryan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, rm. 1615
Silver Spring, MD 20993-0002
Phone: 301-796-6283,
michael.ryan@fda.hhs.gov

My comment:  FDA-2013-N-0430-0001  May 29, 2013 at 6:45pm CT

510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

Question D: Risk-Based Stratification of Medical Devices for 510(k) Modifications Purposes

The 510(k) process is not patient centered and this omission causes patient harm.  FDA perpetuates harm by allowing the public to believe that there is scientific research/clinical study performed prior to marketing and implantation of a device.  In addition, the public believes that if a device proves defective, unsafe or ineffective (as in a consumer product failure) the harmed patient will have rights to justice and be cared for medically and financially and any future preventable harm will be stopped.  In fact, the medical provider is not legally responsible for notifying FDA if there is an adverse event with an implant, unless there is a fatality.  In addition, the FDA is not charged with providing an independent investigation of the event.  The harmed patient is charged with finding a lawyer willing to file a lawsuit (often in federal court) and risk their careers on a lawsuit that will cost them more than it will return financially (tort reform limits settlements).  The 510(k) serves to perpetuate the bureaucracy of the FDA, profit the entitled medical device industry and imperil patient safety.  Joint replacement is now the #1 category of expenditure of Medicare yet UDI’s (unique device identifiers) and post market surveillance is lagging.  The U.S. public is paying for countless unproven implanted medical devices that fail and many patients require long-term rehabilitation, often at public expense.

On July 29, 2011 the Institute of Medicine returned a FDA commissioned study report to FDA/CDRH stating

“The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

Given that the FDA/CDRH rejected this advice via FDA/CDRH Director Dr. Jeffrey Shuren’s press release (that day) stating “FDA believes that the 510(k) process should not be eliminated . . .” 

According to Barry Meier of the New York Times  “As of October 2011, some 3,500 patients had filed a lawsuit involving that (J&J DePuy metal-on-metal hip) device.

There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.”

Jane Akre, on May 24, 2013 reports on Mesh Medical Device News Desk that “21,257 Cases Filed in Federal Transvaginal Mesh Litigation.”  These harmed women have implanted surgical mesh complications that prevent them from having sexual relations, may develop auto-immune disorders, experience extreme pain, may be prevented from returning to work and normal activities for a permanently implanted failed product that was cleared via 510(k).

Stop patient harm.  Follow the IOM instructions to design a system for scientific evaluation of patient harm/risk designed for protection from dangerous and unnecessary medical device implants. 

Steven Baker (MedWatch adverse event #5009052)

Joleen Chambers  (completed training workshop for FDA/CDRHPatient Representative, September 2010)

Women: Hip Implants 29% More Likely to Fail

Hip Implants More Likely to Fail inWomen

By John Gever, Senior Editor, MedPage Today

Published: February 18, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Failure rates for hip implants were 29% higher for women than men in a large U.S. registry study after controlling for a variety of factors including device type, researchers said.

With a total of 35,140 patients undergoing primary total hip arthroplasty followed for a median of 3 years, the crude all-cause rate of failure (defined as subsequent revision surgery) was 2.3% for women (95% CI 2.1% to 2.5%) compared with 1.9% for men (95% CI 1.6% to 2.1%), according to Maria C.S. Inacio, MS, of the Southern California Permanente Research Group in San Diego, and colleagues.

After adjustments for age, body mass index, diabetes status, degree of presurgical symptom severity, implant fixation method, device category, and femoral head size, the authors calculated a hazard ratio (HR) for revision of 1.29 for women versus men (95% CI 1.11 to 1.51), they reported online in JAMA Internal Medicine.

The risk appeared most prominent for aseptic revision (HR 1.32, 95% CI 1.10 to 1.58) compared with septic failure (HR 1.17, 95% CI 0.81 to 1.68), the researchers found.

Larger femoral head sizes appeared especially problematic for women. For head sizes of 36 mm or more, the adjusted HR for failure in women versus men was 1.49 (95% CI 1.14 to 1.95), whereas differences in revision rates for smaller head sizes were not significant after adjustment.

Much of the increased risk for women also seemed concentrated in metal-on-metal implants, with a doubling in risk for women versus men (adjusted HR 1.97, 95% CI 1.29 to 3.00).

But that was primarily because of reduced risk of failure with metal-on-metal devices in men (adjusted HR 0.68 versus highly crosslinked polyethylene, 95% CI 0.45 to 1.02), whereas in women, the adjusted failure rates for metal-on-metal versus crosslinked polyethylene were similar, adjusted HR 1.07, 95% CI 0.72 to 1.60).

Clinical Implications?

In an accompanying commentary, Diana Zuckerman, PhD, of the National Research Center for Women and Families in Washington, D.C., suggested that the study's clinical implications were relatively trivial.

She noted that most patients considering hip replacement are already suffering pain and limited mobility and have few other options.

"Knowing that their chances of success are lower than men's is not helpful to women who are unable to perform many activities of daily living," Zuckerman argued.

Instead, she said, what is needed is "long-term comparative effectiveness research based on large sample sizes, indicating which total hip arthroplasty devices are less likely to fail in women and in men, with subgroup analyses based on age and other key patient traits, as well as key surgeon and hospital factors."

But Glenn Don Wera, MD, of UH Case Medical Center in Cleveland, told MedPage Today that the study provided valuable insights into the reasons for higher failure rates in women.

He noted that the higher rate of revision in women was already known from Medicare data. In the current study, however, "they were able to control for a number of clinical factors, including the kind of prosthesis the patient had, the experience level of the surgeon, and the different institutions and the different prostheses they were using."

That the increased risk in women was still evident despite adjusting for those factors indicates that something else, such as women's generally smaller stature, is responsible, Wera suggested.

Revision Rate: Beyond Infection

Data for the current study came from the Kaiser Permanente system's registry of total joint replacements from 2001 to 2010. Procedures were performed at 46 hospitals in California, Hawaii, Oregon, Washington, and Colorado by 319 different surgeons.

The registry is the largest of its type in the U.S., the authors said and includes data on surgeons' and hospitals' arthroplasty procedure volumes; the patients and the implants they received (cemented, uncemented, or hybrid); and implant bearing surface, such as metal on metal, metal or ceramic on highly crosslinked polyethylene, or ceramic on ceramic. The researchers put the DePuy metal-on-metal hip resurfacing monoblock device into its own category.

Only patients undergoing unilateral procedures were included in the analysis.

About 58% of the 35,140 procedures were performed in women (mean age 65.7 versus 63.8 for men). Just over 60% of both sexes had scores of 1 or 2 on the American Society of Anesthesiologists index, with nearly all of the remainder having scores of 3 or more.

The age difference between men and women was statistically significant. In addition, women in the cohort tended to be slightly more likely to be white or Asian and to have osteoarthritis, rheumatoid arthritis, or dysplasia. They were less likely to be diabetic or obese and to have osteonecrosis or post-traumatic arthritis.

Not surprisingly, women were much less likely to have implant femoral head sizes of 36 mm or more (32.8% versus 55.4% for men, P<0.001). About twice as many men as women had metal-on-metal bearings (19.4% versus 9.6%), whereas ceramic or metal on highly crosslinked polyethylene were more popular for female patients (P<0.001).

The DePuy resurfacing implant was used in 1.3% of women versus 2.6% of men (P<0.001).

Preferences for fixation types also differed between men and women, with hybrid methods more common in the women and cementless fixation more common in men.

Mean surgeon and hospital volumes did not differ between sexes.

The authors noted that with no significant increase in risk of septic failure for women, their results mean that "factors other than infection" are responsible for the higher overall revision rate.

Limitations to the analysis include its observational design, the relatively short follow-up period, lack of data on some potential confounding factors, and the use of revision surgery as the definition of implant failure. Also, the researchers used relatively broad categories of implant type, conceding that design variations within these categories could have influenced the results.

The study was funded by the FDA.

Study authors and Zuckerman declared no relationships with commercial entities. Several study authors were Kaiser Permanente employees.

Primary source: JAMA Internal Medicine
Source reference:
Inacio M, et al "Sex and risk of hip implant failure: Assessing total hip arthroplasty outcomes in the United States" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.3271.

Additional source: JAMA Internal Medicine
Source reference:
Zuckerman D "Hip implant failure for men and women: What and when we need to know" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.19.