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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Thursday, November 10, 2011

National Women's Health Network speaks out on failed dangerous medical device implants.

Dear Friends,

Yet again the health and safety of women are taking a backseat to corporate interests
! You’ve heard from us before about terrible harm done to women by dangerous – like
 devices breast implants and weight loss devices – that the Food and Drug Administration (FDA) has approved without adequate research to demonstrate that the products are safe and effective.  Now the House of Representatives is considering 10 bills that would further weaken the FDA’s standards for medical devices. The changes proposed by the leadership of the House Energy and Commerce Committee would: 
  • restrict what questions the FDA can ask the manufacturer about a new device
  • require the FDA to review devices faster without allowing adequate time to review safety concerns
  • change the FDA’s mission, tilting the balance away from protecting public health
Medical device manufacturers claim these changes are needed to foster innovation.  But the NWHN believes that innovative medical devices have to be safe and effective, and they should address unmet health needs.  If these bills become law, many more people would be exposed to untested devices that may be ineffective or dangerous.  Innovative products that harm patients, will do no good for women’s health.

The experience of the millions of women who have been hurt by dangerous devices shows that the standard for approving medical devices is already too low.  In many cases a company doesn’t even have to prove that a new device is safe and effective to be allowed to market it – all they have to do is prove that it is similar to a device already on the market.  Congress needs to make the FDA’s standards for medical devices stronger – not weaker -- and to encourage the agency to do a better job monitoring what happens to the devices it has approved.

Contact your Representative
 and urge them to protect women’s health by opposing these 10 bills and supporting legislation that would raise the standard for device approvals and provide the FDA with the authority it needs to conduct adequate post-market safety surveillance.

Thank you,

Cindy Pearson
Executive Director
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National Women's Health Network
PH: 202.682.2640 | FAX: 202.682.2648 | For health information: 202.682.2646
1413 K Street, NW, 4th floor, Washington DC 20005

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