Re: [ERC] IMPORTANT ALERT: Withdrawal of 'GYNECARE INTERGEL Adhesion
From: Kayla (anonymous@obgyn.net)
Thu Apr 17 11:40:57 2003
I know that this might have been used in my surgery last Monday and
previously...I am calling my surgeon today!
At Thu, 17 Apr 2003, anonymous@obgyn.net wrote:
>
>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
>>>
--
Kayla
**Just someone who cares, preparing for the medical field**
![[ endo@obgyn.net ]](../../images/endo_at_obgyn.gif)