Old Proplast info may be new to others

From: The Webby (nospamattmjiatroepidemicnospam_at_san.rr.com)
Date: 12/10/04 

Date: Fri, 10 Dec 2004 19:56:49 GMT

For the benefit of those who are unfamiliar with the problems associated
with TMJ implants and a material known as Proplast, I offer the
following.

http://www.mindfully.org/Plastic/Teflon/Jaw-Implants-Fault29jul02.htm

Link provided within Peter Meiers' webpage.
http://PMeiers.bei.t-online.de/index.htm

An excerpt from the above link:

> It's hard to say what did not go wrong with the jaw implant recall. Normally,
> it is up to the manufacturer to alert medical institutions, and at times, to
> collect existing devices. But in this case, the manufacturer, Houston-based
> Vitek Inc., went bankrupt, so the FDA stepped in. Elaine Crosby, then the
> agency's compliance officer in Dallas, says her office did everything
> possible to notify patients through their doctors. The FDA also issued a
> press release, but it was overshadowed by news of the Persian Gulf War.
> Congress later ordered the FDA to conduct a more effective public-information
> campaign, but the agency did not issue any further press releases. "In
> hindsight," says David Feigal, director of the FDA's Center for Devices and
> Radiological Health, "we could've tried to make this more of an issue."
>
> Yet the law severely limits what the FDA can do. The agency seized Vitek's
> records, but they named only doctors and hospitals, not patients. Crosby says
> the agency tried to contact every institution and physician, but the law did
> notand still doesn'tallow it to force doctors or hospitals to take action.
> "Some huge proponents of the device felt it wasn't necessary to notify their
> patients," says Crosby. Doctors argued that patients were hard to locate;
> patients contend that doctors were afraid of being sued. Whatever the case,
> implant victim Leslie Zatezalo of Pittsburgh says she never received a recall
> notice even though her surgeon managed to send her regular bills. And Darcy
> Holleman of Warner, N.H., received jaw implants six months after the recall.
> She had them removed last year in a 16-hour surgery to clean out Teflon
> debris and destroyed tissue and to reconstruct her jaw.

For those who have any personal experience in this matter, this old
information will never be forgotten.

The Webby

Relevant Pages

  • Re: FDA to take "unprecedented" action Re: pain meds
    ... They're going to drive any doctors even remotely close to retirement to do ... chronic pain issues. ... The FDA sent letters to 16 companies in February ordering them to design ... The companies at Friday's meeting produce 24 opioid drugs - including ...
    (alt.support.chronic-pain)
  • NOW: Uninformed Choice is No Choice at All
    ... Drug Administration (FDA) decision to send an approvable letter ... company that makes these implants, to the role of a senior manager at ... decision to issue Mentor Corporation an approvable letter to market ... were not sufficient to demonstrate long-term safety of their product. ...
    (talk.politics.medicine)
  • Re: OT- Female Senators Caution FDA on Breast Implants
    ... Female Senators Caution FDA on Breast Implants ... The letter also noted differences between saline and silicone implants, ...
    (sci.med.diseases.lyme)
  • [News Release] FDA Endangers Womens Health With Silicone Breast Implant...
    ... FDA Endangers Women's Health With Silicone Breast Implant Decision ... breast implants, outlining specific conditions which Mentor must ...
    (soc.feminism)
  • FDA Move on Breast Implants Draws Swift Reactions
    ... FDA Move on Breast Implants Draws Swift Reactions ... The nine senators sent a letter to FDA Commissioner Lester Crawford ... The letter also noted differences between saline and silicone ...
    (sci.med.nursing)