Essure is a permanent sterilization device for women. This medical device is a nickel-based metal coil designed to be inserted into the fallopian tube and cause tissue scarring. It was approved through the Food and Drug Administration’s most rigorous approval process known as Premarket Approval (PMA) in 2002.
For tens of thousands, the personal decision to pursue this non-surgical method of permanent contraception left them with debilitating pain, allergic reactions to nickel, loss of teeth and hair, and countless other complications. What’s worse, the defective device led to at least four women’s deaths and nearly 300 miscarriages. Tragically, because of how current law is written, the manufacturer cannot be held liable for their deaths or the harm and suffering the device has caused for tens of thousands of other victims.
Due to an oversight in a 1976 law, the PMA granted by the FDA bureaucracy completely shields the manufacturer of the device from liability should the device cause severe patient harm or even death. The Supreme Court upheld that interpretation of the law in a 2008 case called Riegel v. Medtronic.
The Medical Device Safety Act, introduced in the 114th Congress,will resolve this injustice and ensure that medical device manufacturers are incentivized to maintain the safest and most effective products for all patients. Nearly 30,000 women have been harmed by the Essure device whose stories have gone unheard. This bill also would ensure that any future PMA device that causes severe injury or death is not exempt from having to answer to the victims.
Some may say this will stifle innovative new devices. There is no doubt that innovative medical devices are saving lives every day. The Medical Device Safety Act will do nothing to stifle that innovation. In fact, it will start to align device laws with drug laws, which currently do not get the same blanket liability protection device manufacturers currently receive. Second, this law only affects a small number of devices that are approved each year by the FDA. The vast majority of medical devices, over 4,000 per year, come to the market via an expedited approval pathway known as 510(k). Meanwhile, all of the 510(k) cleared devices currently are subject to liability should they harm or kill patients. Again, the Medical Device Safety Actwould simply align that current law and apply it to 60 devices that receive a PMA each year from the FDA.