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.
Please share what you have learned!
Twitter: @JjrkCh

Thursday, December 22, 2011

Medical Device Double Jeopardy?

Link to NEJM here. Breast Implant disappears during Pilates exercise.

This very brief article remarks upon treatment of a Maryland woman who had breast implant prosthesis (breast cancer).  She reported that her breast implant was swallowed into her body and disappeared.  The medical providers located the implant and added surgical mesh!  

Surgical mesh is a medical device that is being questioned for its' safety and effectiveness, yet surgeons continue to implant it into unsuspecting patients.

What protections will she be provided if the surgical mesh proves to be a problem rather than a solution?  That is what Congress is responsible for determining:  right now, the charter of the FDA disallows patient stakeholder voting rights, there is no independent, accessible post-market data registry and legal protections unfairly favor the medical provider and medical device industry.   Patients beware!

No comments:

Post a Comment