Metal-on-Metal Hips: A Tale of Harm, Weak
Medical Device-Approval, and Lax Postmarket Scrutiny

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Hip replacement, National Institutes of Health

Nearly 1 million metal-on- metal hips have been implanted in patients in the United States, making the US the world’s largest consumer of the implants. According to a BMJ/BBC Newsnight Investigation released today, the “risks associated with these devices have been known for decades, yet patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment.” At issue are “leaky hips,” specifically, “release of metal ions that can seep into local tissue causing reactions that destroy muscle and bone and leaving some patients with long term disability,” writes Deborah Cohen, BMJ’s Investigations Editor. In a companion paper, Carl Heneghan, MD, director of the Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK, and coauthors, point to the litany of safety warnings out on these implants for a decade or more.

Together, these reports point out:

  • internal memos deemed proprietary acknowledging safety issues dating back more than a decade;
  • lack of medium-to-long-term safety and reliability data on these devices;
  • uncertainty about safe levels of metal (cobalt and chromium) ion exposure;
  • design flaws;
  • a weak device regulatory approval process, seemingly more intent on rapid market entry, and not requiring clinical data submission prior to approval;
  • postmarketing databanks in the EU that alone are insufficient for flagging safety;
  • and despite all of this, exhibitors at a February 2012 American Academy of Orthopedic Surgery annual meeting, showcased metal-on-metal hips to thousands of attendees.

This story is hardly new, but what’s alarming is that the metal-on-metal hip story is emblematic of how thousands of medical devices like hip implants get out to market. FDA does not require clinical data submissions, but merely proof that the implants are “substantially similar” to other devices already out there through FDA’s 510(k) program.

Richard Deyo, MD, Professor of Evidence-Based Family Medicine, Oregon Health and Science University, Portland, OR, reviewed the report. In an email, Deyo wrote: “I think implanted medical devices should have much closer pre-approval scrutiny than they currently receive, and there is a need for much better post-marketing surveillance. The latter might uncover problems of this sort before too many patients are affected.”

As far as patients are concerned, Deyo wrote: “Patients may want to inquire as to the length of the track record for any implantable device. This is a situation where it’s not safe to assume that the latest is the greatest. It often takes years to learn about the durability of implants, and some new devices prove to be worse than older ones.”

Rita F. Redberg, MD, Professor of Medicine at the University of California San Francisco, told Patient POV:  ““We are dependent on foreign registries for data on hip implants and currently,there is no provision that would require collection and reporting of such data.” Redberg says we need more data in the  FDA premarket process, as well as more consistent and complete postmarketing surveillance. “A  US hip and knee registry would help,” Redberg said, adding that plans for such are moving very slowly.

Hip and knee replacement registries are further along outside of the United States. In 1999, Australia launched a mandatory, confidential hip and knee registry that generates detailed information on outcomes, implant performance, patient deaths, and revisions. Proponents say that it has been helpful in real-time quality control, in weeding out poorly performing implants, as well as pushing orthopods with less-than-optimal outcomes to improve their technique or stop doing implants. New Zealand similarly launched its registry in 1999.

In both Australia and New Zealand, individual surgeon data has not been discoverable, but this has been a sticking point for the US-based Association of Health Care Journalists and ProPublica, who have been fighting in the US to have the HHS National Practitioner Databank accessible at the provider level.

Patients need to think through who they should lobby to improve their odds of getting a safe, new hip, pacemaker, or new knee, should they need them. Thousands of devices become FDA approved through the 510(k) process, without clinical data submission. Sadly, I doubt most of us, including me, have tools available to make the best choice on where to go for a hip implant with a good track record and an orthopod with good outcomes. I haven’t found the websites of orthopedists very helpful.

A mandatory, real-time patient registry with uniform requirements would be a step in the right direction, but headway in this area has been slow. Putting safety first and insisting that industry submit clinical data before the FDA approves new devices is paramount. The 510(k) process needs to be abandoned and supplanted with clinical data reviewed by FDA. Postmarketing surveillance needs to be ramped up so that safety problems are flagged as early as possible. Comparative effectiveness research could also go a long way in evaluating the safety of implanted devices. Even though cost effectiveness research provisions are in place through the Accountable Care Act, orthopods have yet to contribute to the process.

An earlier version of this article misquoted Dr. Redberg. The corrected quote appears above.


Join Patient-Centered Outcomes Research Institute (PCORI) Dialogue on National Research Priorities Today

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Are you interested in participating in efforts to shape patient-centered outcomes research priorities. Then, don’t miss today’s meeting, webcast starting 9:30 am, or via telephone to 800 number line posted below. Got comments for the PCORI people: see submission guidelines. Disclosure: This blog is independent and not part of this effort.

The Patient-Centered Outcomes Research Institute (PCORI) will hold a National Patient and Stakeholder Dialogue on its first draft National Priorities for Research and Research Agenda on Monday, February 27, 2012, from 9:30 a.m.-5:00 p.m. EST, at the National Press Club in Washington, D.C.


View Webcast

The event will dedicate three and a half hours to receiving public comment, and include presentations by PCORI and a roundtable discussion involving patient advocates, clinicians and others from the health care community.

Individuals can register to attend and provide public comment here. A webcast and teleconference will be provided. A portion of the comment period will be reserved to receive input from individuals participating by phone.

Advanced Registration is now closed, as of February 23, because the event space has reached capacity. The webcast will remain open to the public. You do not need to register in advance to view the webcast.

The event webcast will feature full audio through your computer so there is no need to call in to the teleconference if you are watching online. We strongly encourage individuals with internet access to watch the webcast to keep the phone lines open to those who do not. You can access the Monday’s webcast here.

To listen to the event by telephone call: 800-704-5185.

The National Patient and Stakeholder Dialogue supports PCORI’s public comment period on the national priorities and research agenda and provides individuals an opportunity to speak directly to PCORI in an open, public format.

Guidelines for Public Comments

An Update: The Patient-Centered Outcomes Research Institute Meeting in New York

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After urging readers to attend the Patient-Centered Outcomes Research Institute (PCORI) daytime meetings in New York on Monday and Tuesday of this week, I have to say that after attending day 1, I was disappointed. That’s because it turned out to be primarily a business meeting with a mandatory public invite because PCORI is federally funded.

Members of the audience sat passively in the audience because they were not part of the PCORI Board of Governors. Therefore, plenty of the discussion went on as if we were not there. You may as well have been behind glass. No agenda or handouts were available on site for the audience, but I was told that materials were posted on the PCORI website the day before.

The day’s events were webcast, but the webcast is no longer available. A public comment period was part of  both days. Most commenters in the Monday session pressed for inclusion in the work that follows.

I don’t fault PCORI for the way that the day unfolded. The group is just beginning. And I regret that I was unable to make the evening discussion forum, which was set up for public discussion.

I was impressed that some of the Board of Governors went out of their way to engage participants during the breaks, promising to move towards inclusion of the public. I have hopes that if PCORI involved the public and patients in a meaningful way, and from the outset, perhaps health care research would focus more on what matters to patients, not what researchers assume should matter to patients.

Involving patients early on would also have a more far-reaching societal benefit: more Americans would see firsthand the potential of healthcare research and healthcare reform to work for them.

Reminder: Patient-Centered Outcomes Research Institute Seeks Public Comment on What Matters to Patients

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Designing healthcare research with what matters to patients is a relatively new concept in healthcare research. If the healthcare reformers who envisaged what is called “patient-centered outcomes research” truly want to hear from patients and the public, then tomorrow’s meeting  in New York of the Board of Governors of the Patient Centered Outcomes Research Institute (aka PCORI), soliciting public comment on research priorities will be a seachange in healthcare research.

It would be great if you went if you went and offered your thoughts on research priorities.  Let researchers know about the gaps in care and practice that you have experienced and make a case for funding research into those areas.

Again, here are the details:

This Monday and Tuesday, May 16-17, 2011, the Patient Centered Outcomes Research Institute Board of Governors Meeting will be held at the

Millennium Broadway Hotel

145 West 44th Street, New York, NY 10036-4012

Draft Agenda

Monday, May 16, 2011

1:00-1:10 pm Welcome and Approval of Jan. Board Meeting Meeting Minutes

1:10-1:45 pm Presentation and Discussion of Mission Statement and Logo

1:45-3:15 pm Program Development Committee Report

3:15-3:30 pm Break

3:30 to 4:00 pm Public Comment Period

4:00 to 5:30 pm Methodology Committee Report

5:30 pm Adjournment

Discussion Forum Monday evening

Tuesday, May 17, 2011

8:00 – 8:45 am Finance and Administration Committee Report

8:45 – 9:15 am Consideration of and Vote on Budget

9:15—9:45 am Public Comment Period

9:45 – 10:15 am Break

10:15-11:30 am Public Affairs and Communications Committee Report

11:30-11:45 am Wrap-Up and AdjournmentAll of the  sessions are open to the public. Individuals only need to RSVP to the evening session. If you want to issue a public comment on the day of the event, you can sign up to speak on-site the day of the event or can provide PCORI advance notice of their intent to speak by emailing

Hope you all had a great weekend! Give me a shout if you are there, planning to go, or if you cannot make it and have something that you want them to know. You can raise it in a tweet to me at lauranewmanny or via email at patientpov “dot” gmail “dot” com.


Upcoming Event: Putting the Patient in the Center of Health Care Research

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Has health care research seemed removed from you, as if it happens from the top down? That’s understandable.

Health policy people and reformers often lament that they exist in a separate world, wondering what the heck matters to patients. So I was intrigued yesterday when a friend called to tell me that there was a notice in the Sunday New York Times inviting the public to a forum on Patient-Centered Outcomes Research in New York City, Monday, May 16, 2011. (I could not find it in the NYTimes online.) Please note important additions to this post, including information on two days of meetings.

If you are interested in health care, wonder how researchers set priorities for health care research, and especially if you have a point of view on what treatments and tests should be studied further, I urge you to RSVP and attend. Registrations must be received by Thursday May 12.

And if you wonder what health care reform might be able to do for you, focusing on what matters to patients is a big part of the 2010 health care reform law, also known as the Patient Protection and Affordability Act (PPACA), sometimes pronounced P-PACKA. I am taking pains to explain this because I worry that a language barrier exists between people who have been involved in legislation and policy and patients.

The health reform law created a non-profit Patient-Centered Outcomes Research Institute, a nonprofit organization that is independent from the government, with several different people representing different interests (a.k.a. stakeholders) who sit on a Board of Governors. This effort began in 2009 with stimulus money of $1.1 billion to support comparing available treatments, using a variety of research strategies.

The goal is to use what is called “comparative effectiveness research” or CER. It sure can sound like jargon, but when you break it down, CER rigorously compares available treatments, using a range of research methods, such as clinical trials, observational studies, systematic reviews, and structured assessment of evidence available from several primary studies. By 2014, public-private funding totaling $650 million will support the program.

I have no idea how the small group discussions about research priorities will go, but if you are interested in seeing the patient voice taken seriously in health research, you might try to make it. This forum is just one of several around the country. I will keep you posted.

The Patient Centered Outcomes Research Institute Forum

is set for:
Monday, May 16, 2011, 7:00-9:00PM. EST
Millennium Broadway Hotel New York, Gallery 8 on the 8th Floor (right near Times Square)
145 West 44th Street, New York 10036-4012

You must RSVP to no later than Thursday, May 12. When registering, you should write in the subject line “NY Stakeholder Discussion Group” and in the body of your email “RSVP.” Further details on the forum are posted.