While we can celebrate the demise of the Essure medical device, it doesn’t enforce the safety of all medical devices that cause damage and complications to patients. That’s why the Medical Device Safety Act, H.R. 2164, which was introduced by Brian Fitzpatrick and co-sponsored by Congresswomen Rosa DeLauro and Louise Slaughter. 

The package bill will allot more resources for patients when the Food and Drug Administration (FDA) doesn’t do its job. 

The Medical Device Safety Act aids victims of Essure and allows themto “seek legal recourse and ensures medical device manufacturers are incentivized to maintain the safest and most effective products for all patients.” Manufacturers are virtually exempt from compensating injured patients seeking legal justice. There are 157 Class III, or high risk, medical devices currently on the market where the manufacturer is not liable for death or injury. 

The sixteen-year debate with Essure and Bayer is devastating as it’s clear that devices are allowed on the market without much concrete research or clinical trials. Patients are left confused, lost, and in debilitating pain. For many, drug safety is at the top of the totem pole, where medical devices fall much lower and are therefore approved through various loopholes. 

A jarring and heartbreaking moment in The Bleeding Edge documentary reveals the FDA Premarket Approval hearing where members on the panel are laughing about the possibility of the Essure device causing concerns for patients in the future. The footage, shot in 2002, is now a reality for thousands of patients, but no one is laughing this time. While Bayer has agreed to stop manufacturing the device in the U.S., the consequences are forever. 

In an official press release, Louise Slaughter said, “This is about saving lives. I have met with many families who have endured unspeakable tragedy as a result of unsafe medical devices. No one should have to wonder whether a device meant to save a life could malfunction with devastating consequences.”

Raising awareness of the Medical Device Safety Act, attending rally’s, and contacting Congressmen, women, and Senators by urging the support of this bill is pertinent in the future of victims from medical devices. 

Contacting representatives is necessary when enacting change and impacting the success as the bill still needs to go through the House and Senate. 

→ To support the Medical Device Safety Act, follow this link to visit Petition2Congress where you can automatically email your representative free of charge.


Featured photo by Alice Donovan Rouse on Unsplash