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Why Are Unsafe Medical Devices Used in the U.S.?
It remains a mystery to many people; how is it possible that medical products, such as hip replacement devices and birth control devices, which are ruled unsafe in other countries are still used in the United States on a regular basis? Thousands of patients in the U.S. suffer needlessly after receiving implants that are prohibited in other countries around the world. The reason why is complex – and for many, absolutely maddening.
A Chaotic System
A recent NBC News report showed how a lack of global cooperation could lead to incredible suffering. The article highlighted the story of a man who received two Biomet M2a Magnum replacement hips in 2011. Within six years, he was in crippling pain due to problems with the implants. Doctors found the implants had caused severe bone damage. In addition, tiny shards of metal were coming off the implants and entering his bloodstream. The implants were removed in 2017.
The man had no idea that, as early as 2015, regulators in seven countries had issued warnings about Biomet hip implants after patients in those countries reported severe complications. The reason is that the U.S. Food and Drug Administration (FDA) issued no such warnings. He said if he had known the Biomet implants were causing his problems, he would have had them removed earlier – potentially saving him years of misery.
Another example of the FDA falling behind international regulators involves Essure, a birth control device introduced to the U.S. in 2002. This device has been associated with severe complications, including back pain, urinary tract infections, bleeding, abdominal spasms and many others. Even though French authorities began investigating the device in 2015, and Italy and Singapore issued safety alerts in 2016, the FDA didn’t begin to restrict Essure sales until 2018.
Unfortunately, part of the problem is a lack of global organization when it comes to medical devices. Each country has its own methods of addressing devices that cause adverse events, and, according to the article, physicians in some countries don’t have access to safety information that is available in other countries. Sadly, it appears this issue is not going to change anytime soon.
If you have suffered complications due to a defective medical device, Baron & Budd may be able to help you obtain justice – whether or not the FDA has acted. Please give us a call at 866-520-2755 or complete our contact form to learn more.