Re: [ERC] IMPORTANT ALERT: Withdrawal of 'GYNECARE INTERGEL Adhesion
From: anonymous@obgyn.net
Thu Apr 17 08:22:15 2003
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" <anonymous@obgyn.net>
>>Reply-To: anonymous@obgyn.net
>>To: <anonymous@obgyn.net>, "anonymous@obgyn.net"
>><erc@yahoogroups.com>
>>CC: "ERC Dir. of Special Projects" <anonymous@obgyn.net>
>>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
>>
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