Dr. Oz’s heart valve: A cautionary tale about medical devices

Dr. Oz proudly endorses an implantable heart valve that he had a role in inventing, which won FDA approval in 2013. Yet, David Hilzenrath and Holly Hacker report for KFF Health News that the valve might be hurting more people than it’s helping. Overall, the FDA does a poor job of monitoring medical devices on the market and warning people of malfunctions.

MitraClip, the brand name for the heart valve, is intended to allow patients to avoid open-heart surgery. It could treat tens of thousands of people with mitral regurgitation, a condition in which blood flows backwards through the heart. But, thousands of people have reported that it often doesn’t work and can harm patients. Eleven hundred people have died from the device, according to FDA records.

The MitraClip is manufactured by Abbott and costs $30,000. As of 2019, it had been inserted in 200,000 people worldwide. And, Dr. Oz has received hundreds of thousands of dollars in royalties from the MitraClip. Yet, one FDA outside adviser said that the data showing clinical benefits of the MitraClip was “poop.”

In March 2013, the FDA reported to its outside advisors that “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered.” In a close vote, the majority of the committee determined that the MitraClip was not effective, but they overwhelmingly thought it was safe and risks were minimal as compared to benefits. And, the FDA approved the device shortly thereafter for a limited group of patients.

Since its approval, the FDA has recalled MitraClip products three times. One recall warned of “potentially deadly consequences,” but Abbott continued to promote the MitraClip. A pending lawsuit claims that Abbott illegally persuaded doctors and hospitals to use the device. How did the FDA allow this device get to market?

Bottom line: You should not trust the FDA to protect you from medical devices that are unsafe. The FDA acts extremely slowly and, in some cases, does not act in the interest of Americans. Consequently, thousands of patients are harmed or die needlessly. The FDA and Abbott continue to say that the MitraClip is safe and effective.

Here’s more from Just Care:

• Why aren’t medical devices tested against placebos?
• Beware of faulty medical devices
• Medical device company gouges hospitals that use its surgical robot
• FDA hides data on medical device malfunctions and injuries
• FDA permits doctors to implant untested medical devices at extreme risk to patients