Testimony at FDA Advisory Committee Hearing on Metal-on-Metal Hip Implants

I am Dr. Diana Zuckerman, president of the National Research Center for Women & Families.  Our Center does not accept funding from device companies, so I have no conflicts of interest.

Our nonprofit Center analyzes and reviews research on medical issues, and provides objective and understandable information to patients and providers.   My perspective is as a former faculty member at Vassar and Yale and research director at Harvard.  I am also currently a fellow at the University of Pennsylvania Center for Bioethics.

I was trained in epidemiology at Yale Med School, so I focus on quantitative data – real proof of benefits and risks.  And when I met with several surgeons to decide what to do about my painful hip exactly 2 years ago, I asked questions that most patients don’t ask.

I read all the research studies I could find – that didn’t take long.

I asked the surgeons about implant materials and I asked which company made the best implants.  I was amazed at how little objective information there was, and how there were so many different hip models that it was virtually impossible to get useful data on which hips were safest and most effective.  When I finally found some data, the hips involved were not sold in the U.S.

The first thing I decided was that I would NOT get metal on metal hips.  I knew enough about friction and debris wear that metal on metal seemed like a ridiculous idea.  I chose the surgeon who felt the same way.

Two years later, there are better data on metal on metal hips than I ever found in PubMed, but FDA does not seem to take the data seriously.

The data clearly show that metal on metal hips don’t last as long as metal on polyethylene.  As a patient, that’s all I would need to know to decide against metal on metal.

I’ll tell you why.

The surgery is not fun.  I was very healthy and relatively young for hip surgery, and the recovery was horrible.  I couldn’t sleep.  The pain killers had many miserable side effects, and when I went off them I was in pain.  I was nauseous for weeks, and I was not allowed to drive for a month.

I was lucky.  I’m the boss so I didn’t lose my job.  I could recover at home because I had loved ones to take care of me.  I had great insurance so I paid about $650 for my $35,000 surgery and rehab.  A nurse and physical therapist come to my home when I needed them.

But even so, if I had to have a revision surgery in the next few years because my implant isn’t as good as other implants, that would be devastating.  Having hip surgery is debilitating and horrible, and by all reports, revision surgery is often worse.

I have 5 questions to add to FDA’s lengthy list of questions for you:

#1.  Where is any evidence of any advantage of MOM hips that would justify keeping them on the market, given the higher revision rate?  By evidence, I mean data from scientifically conducted clinical trials.

#2.  Why do women have more problems with MOM hips than men?  Is there any research underway to explain that?

#3.  Why would a doctor recommend metal on metal hips based on the current scientific evidence?  Especially for women.

#4.  Why should FDA allow MOM hips to remain on the market given the lack of evidence that they have benefits that outweigh the risks, compared to metal on polyurethane hips?

#5.  Why should all of us pay an extra $3.5 billion so that 100,000 patients with MOM hip implants can suffer through an additional revision surgery that they otherwise would not need?

I have not talked about the other adverse outcomes from MOM hips, such as the toxicity of heavy metals in our bodies and the very real risk of serious damage to bone and tissue.  These are of great concern, but I believe the revision statistics are the key issue.

FDA recently had a public meeting about Patient Centered Outcomes, but they seem to have missed the boat with this meeting.  Patients suffer greatly when hips need to be replaced twice as soon as expected.  Patients can lose their jobs and their independence when hip surgery is unsuccessful and needs to be repeated.  Some go into rehab and never go home again, because there is nobody at home to take care of them.  Some never recover from the costs of additional surgery and additional medical bills.  The studies that have been done so far don’t capture these quality of life issues.  They should.

Most important, keeping these MOM hips on the market for the next 5-10 years while research is conducted is not ethical.  Thousands of patients will be harmed in the meantime.  If companies want to sell MOM hips, they should be required to prove their safety first.  FDA made a tragic mistake by not requiring a PMA for MOM hips, and they should not compound that mistake by grandfathering MOM hips while waiting for safety studies that should have been conducted years ago.