|
Re: [ERC] IMPORTANT ALERT: Withdrawal of 'GYNECARE INTERGEL Adhesion
From: Marjorie (anonymous@obgyn.net)
Thu Apr 17 10:06:13 2003
I don't know the answers to your questions- I am just passing it along,
though I do know that the gel works as an adhesion barrier, but there are
several different kinds out there.
>From: anonymous@obgyn.net
>Reply-To: anonymous@obgyn.net
>To: Multiple recipients of list ENDO <anonymous@obgyn.net>
>Subject: Re: [ERC] IMPORTANT ALERT: Withdrawal of 'GYNECARE INTERGEL
>Adhesion
>Date: Thu, 17 Apr 2003 08:25:56 -0500
>
>Marjorie,
>
>Can you tell me what exactly how this is used?
>
>During my laparotomy, my doc placed some type of device between my
>bowels and uterus to prevent any further adhesions from forming.
>
>Are docs being advised to notify their patients if this pertains to
>them?
>
>Thanks-
>
>Lynnette
>
>At Thu, 17 Apr 2003, Marjorie wrote:
> >
> >>From: "ERC" <EndoFL3@aol.com>
> >>Reply-To: erc@yahoogroups.com
> >>To: <ERCSupportGroups@yahoogroups.com>, "Erc@Yahoogroups.Com"
> >><erc@yahoogroups.com>
> >>CC: "ERC Dir. of Special Projects" <EndoFLKAL@aol.com>
> >>Subject: [ERC] IMPORTANT ALERT: Withdrawal of "GYNECARE INTERGEL
>Adhesion
> >>Prevention Solution" from the Global Market
> >>Date: Wed, 16 Apr 2003 16:32:27 -0400
> >>
> >>PASS ON:
> >>
> >>The FDA Safety Information and Adverse Event Reporting Program GYNECARE
> >>Worldwide (a Johnson & Johnson Company) and FDA Center for Devices and
> >>Radiological Health (CDRH) announced the voluntary market withdrawal of
> >>"GYNECARE INTERGEL Adhesion Prevention Solution" from the global market
>and
> >>are urging customers to immediately stop using this device.
> >>
> >>Post-market reports include late-onset post-operative pain and repeat
> >>surgeries following the onset of pain, non-infectious foreign body
> >>reactions, and tissue adherence. In some patients a residual material
>was
> >>observed during the repeat surgery.
> >>
> >>This product has been distributed in the following countries; Austria,
> >>Canada, Egypt, England, France, Germany, Greece, Ireland, Israel, Italy,
> >>Japan, Kuwait, Netherlands, Portugal, Republic of Singapore, Saudi
>Arabia,
> >>Scotland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates
> >>and
> >>the United States.
> >>
> >>Read the 2003 MedWatch safety alert, including a link to the FDA/CDRH
> >>statement, at:
> >>http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#interg
> >>
>
|
|
![[ endo@obgyn.net ]](../../images/endo_at_obgyn.gif)