Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, May 9, 2017

No Objective Patient Outcome Data: Sacrificial Lambs

Updated: May 07, 2017 9:51 AM CDT

By Kent Luetzen

Women from around the country who have been harmed by medical devices such as Essure --  a type of birth control -- used their voices to rally on Saturday. One rally was held in Missoula in hopes of raising awareness about what they call "hidden dangers" of some FDA-approved products. 

The group says women deserve better communication from doctors on the side effects of products and for manufacturers to not hide behind the FDA's pre-market approval certification.
For some of these women, products which were said to be safe have caused serious health issues including autoimmune diseases such as eczema, lupus and celiac disease.
Ray Curtis, who’s wife died from hysterectomy complications, is hoping Montana legislators will continue their work to protect women.
"They're (treated) almost like human guinea pigs. These devices are being used for purposes they weren't intended to be used for," Curtis said.  "Legislation can bring about awareness to begin with, but also get government to protect woman who are unsuspected like my wife and me... we didn't know.."

Missoula's rally was just one of over 20 throughout the United States.

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