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EFHSS Questions and Answers - Answer to Question Q00680

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EFHSS - Questions & Answers - Sterile Storage - Q00680
Silicone Breast Implants
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From: (United States)   Date: 18 November 2004, 06:47 [GMT]
Subject: Silicone Breast Implants

My sister had Dow Corning Silicone breast implants and had to have them removed because of leakage and medical problems resulting from the leakage. She submitted a claim to Dow Corning for a lawsuit. She was contacted recently and told that she would need to send the implants to them in order to continue the process, but the implants would have to be sterilized or they would not accept them. They would not give her any information on how to sterilize them. Her doctor claimed not to know and referred her to the pathology lab. The lab didn't know either.

My sister has suffered a lot due to the implants and I feel that she has been given the "run around". Can you please advise us on what she should do, or who she should contact? The implants are currently in her possession and are sealed in formaldyhide.

Thank you,

Patty Jager

From: Josy Holdener (Switzerland)   Date: 28 November 2004, 13:29 [GMT]
Subject: Re: Silicone Breast Implants

Dear Patty

I feel sorry for your sister and can't understand that neither the responsible physician nor Dow Corning cooperation gives you exact advises where and how the implants can be sterilized. I assume they have to be sterilized for the safety of the Laboratory personnel, they could be sterilized by steam, ethylene oxide or Gamma rays. The reason not every sterilization contract institution is ready to sterilize the implant could be that probably detailed sterilization protocols/results have to be provided.
Yet Patty, as you surely know your sister is not alone with her problem, there must be an organization to help your sister.Did you try "MedWatch Reporting by Consumers" at: www.fda.gov/medwatch/report/consumer/consumer.htm where you can report problems with medical products such as medical devices or go for specific question to www.implantclaims.com
I wish you and your sister all the best!

Kind regards
Josy Holdener

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