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FDA - who owns breast implants following explant

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"Benson, M." <cynthia.benson@...> wrote: From: "Benson, M." <cynthia.benson@...>"Rogene S" <saxony01@...>Subject: FW: Suddenly !Date: Mon, 28 Aug 2006 15:16:22 -0400 Rogene Here is verbatim information from our Office of Device Evaluation regarding patients who desire their explants. Hope this helps! “This is not a breast implant issue so I don’t know that we have anything to send them specific to breast implants. Patients pay for their devices, so they own them – unless they signed something waiving their right to them. They should contact the appropriate hospital regarding the hospitals procedures for handling removed devices and the potential biohazard.” Benson Office of Communication, Education and Radiation Programs Center for Devices and Radiological

Health U.S. Food and Drug Administration 1-800-638-2041, ext. 109

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I knew it!! So the plastic surgeon's office was lying when they said the FDA

rules prohibit

returning them to the patient!!

Someone should show them this.

Oh that makes me angry. I got my implants returned - no questions.

From: " Benson, M. "

<cynthia.benson@...>

> " Rogene S " <saxony01@...>

> Subject: FW: Suddenly !

> Date: Mon, 28 Aug 2006 15:16:22 -0400

>

> st1\:*{behavior:url(#default#ieooui) } Rogene

>

> Here is verbatim information from our Office of Device Evaluation regarding

patients

who desire their explants. Hope this helps!

>

> " This is not a breast implant issue so I don't know that we have anything to

send them

specific to breast implants. Patients pay for their devices, so they own them –

unless they

signed something waiving their right to them. They should contact the

appropriate

hospital regarding the hospitals procedures for handling removed devices and the

potential biohazard. "

>

> Benson

> Office of Communication, Education

> and Radiation Programs

> Center for Devices and Radiological Health

> U.S. Food and Drug Administration

> 1-800-638-2041, ext. 109

>

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