Lisa McGiffert, Director of Consumers Union’s Safe Patient Project, comments to an FDA advisory panel that has been meeting over the past two days on metal-on-metal hips, June 28, 2012.
The most confounding question about metal on metal hips was asked several times yesterday: “Why were these devices implanted in 500,000 people without safety testing? It should have been tried but not on this scale.”
Consumers Union learned a lot during the Congressional debate on the recently passed FDA User Fee Act, mainly that there are many counterforces to creating a common sense system that would prevent this kind of thing from happening again. Recalls, guidances, and post-market studies take a long time during which unsuspecting patients are having devices implanted in them that don’t have the science backing up their widespread use.
Here’s what I learned yesterday: It seems that making a metal-on-metal hip safer is not a solvable problem. There are no benchmarks, too many variables, and too many questions that will take too long to answer.
What can the FDA do to undo this misstep? Three things:
1) Put out an alert immediately: Women should not get metal-on-metal hips, with a strong warning for those of childbearing age. I’m heartened by the discussions of panel members yesterday who kept bringing up the findings of poor outcomes for women with metal-on-metal hips. The alert should also advise every woman with a metal-on-metal hip of possible health issues and encourage them to get a check up. Tell them what to monitor and what symptoms to watch for and that they may need to watch for them for many years. The FDA should enlist the media, organizations (medical societies, consumer, community), social media (email lists, Facebook, Twitter). The agency should spread the word as if it really wants the public to know.
2) Don’t count on doctors or hospitals to give potential patients enough information up front. Informed consent does not work. Doctors don’t know or don’t tell or leave it up to someone else who doesn’t do it either. We need a public version of informed consent, from an unbiased source. Patients don’t get the kind of information they need to be clear about the risks so they can make informed decisions to opt for safer devices or safer alternatives. I have heard this countless times from people harmed by health care and you heard it from patients yesterday: “If I had known then what I know now, I would never have chosen a metal-on-metal hip.”
3) Make sure that doctors don’t embrace future devices without sufficient evidence that those devices are better or more durable than existing ones. Ensure full disclosure to doctors of the limitations of the FDA process that brings devices to the market. Doctors should get notice when post-market studies are ordered at clearance/approval and they should have to disclose information about these studies to patients before surgery. There is so much marketing to use the newest product — we need a counterbalance and FDA needs to be that, with clear and concise information delivered in an effective manner.
Consumers Union supports a national Registry — it should be a top priority. It could begin with implants and high-risk devices. It should be comprehensive and neutral, with FDA having full access to all information in it. It should not be run by manufacturers that produce each device. Another vital function of registries that no one mentioned yesterday: to notify patients and doctors when things go wrong. If we had a national registry in place today, we would be able to easily tell all of those women with metal-on-metal hips about the danger signs they should watch for.
The Sentinel Initiative was not mentioned yesterday. The FDA User Fee bill just passed added devices to this post market system for drugs. It could be an option for answering some of the questions posed by the panel yesterday.
Thank you for the opportunity to speak.