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

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

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

Health Disparities and Behavior Change:
A Plea to Stop the Attack Ads

The NYC Department of Health and Mental Hygiene takes on a poor, white, single-mom, smoker in a harsh black-and-white tv spot. An off-camera announcer essentially tells her to quit smoking or risk leaving her children without a parent. That’s the latest spot, viewable in the New York/NJ/Connecticut market. The NYC Department of Health and Mental Hygiene has been running these in-your-face ads that press for healthy behavior change for awhile, but what’s changing is that more places are pushing them as well. Proponents of the ads claim that shock gets people to pay attention and consider changing their ways. I am not addressing the ads that show diseased lungs or people on oxygen here.

I do not like this television spot at all. Yes, it’s eye-catching, but so what? I don’t think it is going to get poor, white, single-mom smokers to quit smoking. Besides, the spot is completely unsympathetic to the woman.

Fighting Smoking, Confronting Poor Single Moms

The television spot opens with a somber male authoritatively stating:

“Mrs. Wadley, I am sorry. You have cancer.” You see an obviously poor white mom who must smoke, facing a harsh light, having trouble focusing. [Perhaps a harsh flash was used.]

The off-camera voice bellows: “What’s worse than finding out you have cancer?” 

The camera shifts to the woman anxiously facing her children. Their backs are to us and in the foreground. Everyone is fidgety: the woman facing her two kids, and her children facing her.

[The answer] “Telling your children that you have cancer,” states the announcer, who we never see.

For a second, the spot flashes on a list of resources to help you quit–thankfully.  Information flashes on and off so fast that any viewer would have to wait for the next spot to copy the information down.

The announcer sounds like a pompous creep and the woman is made to look like a parasite — as if she warrants a push to care for her children and not leave them without a parent.

Disclosure: I never smoked, but I recognize that cigarette smoking causes lung cancer, and that smoking can kill. I’d like to see interventions that work.

Shock Tactics

I don’t know about you, but anyone who has tried to get me to change my lifestyle who attacks me, doesn’t get very far. Many years ago, a doctor made a snide remark about my weight. When I left the doctor’s office, I made a beeline for a hot fudge sundae. I had a neighbor once who was obese, who was bullied by neighborhood kids. As a result, he went on a crash diet, losing lots of weight. He told me that he was so mad that he wanted to show them he could do it. I wonder whether the weight loss was durable: it’s hard to imagine that bullying would lead to healthy behavior change and better health outcomes. If it works, it is not the kind of society that I want to live in.

An ad campaign by Children’s Health in Atlanta, Georgia,  featuring individual fat black and white kids, was yanked recently when the public objected to the strategy. I asked a few people for comment on these photos of 11-year-old children –isolated shots with each of them looking somewhat uncomfortable in their fat selves.

“At first, you look at it and you wonder if it is child abuse,” emailed one person, responding to the photos in the CNN story linked to in the preceding paragraph. She has an obese adult child and continued: “We probably should have started earlier. Now it is too late.” Another emailed me: “The ads are too harsh. If I were an obese child or youth, I would feel humiliated by them.  The ads also have the potential to give fodder to those who bully obese kids.”

An interesting footnote: in Georgia, more positive role models showing kids exercising and eating healthier are now being used to reduce childhood obesity in Georgia.

Another NYC Department of Health spot features an obese black model with a photoshopped, amputated leg to drive home the point that, if you eat supersize portions, you could end up with diabetes and a leg amputation.

Even though subsequent news coverage focused on the identity of the model, whether he knew he was photoshopped, and the ethics of using actors and photoshop, I’d like to see evidence that ads like this really work,  do not cause harm, or worse still, backfire, leading to even more distrust of health authorities.

In the meantime, I have seen another approach: Michelle Obama competing in push-up challenges and potato sack races on television talk shows and on the White House lawn. I’d like to see more concerted efforts to get the poor and minority regular access to healthy, affordable food. I’d like to see more sympathy regarding the barriers to quitting smoking, eating health food, and exercising when you are poor and you have few options.

Admittedly, my litany here is not scientific.

Many people may think whatever it takes to get people to stop smoking, lose weight, and maintain a normal weight, it is worth it. I disagree. I’d like to see the science that backs these kinds of ad campaigns before they are disseminated any more widely. I don’t think that shaming people who smoke or eat too much for their own good is an acceptable strategy. I can’t believe that a stimulus like this is durable either. If ads like this really work and they don’t harm, researchers ought to share the data. But so far, I just hear empty claims – no outcomes data, no follow-up. If people are motivated to quit smoking or adopt a healthier data as a result of the ads, where is the data?