I am an attorney in Sacramento California and am currently
prosecuting several lawsuits around the country on behalf of women who
have been injured by the adhesion prevention solution commonly known as
Gynecare Intergel. Intergel is an orange gel-like substance that is
designed to prevent adhesions following gynecological operations. The
gel is supposed to act as a lubricant which dissolves in the body
within 7 days.
Intergel came on the market in November 2001 to much fan fare,
only to be recalled approximately one year later. We have been
contacted by numerous women who suffered severe injuries
as a result of this product. Most of the reported injuries consist of
severe pain, swelling, fever, repeat operations, and additional
adhesions. There are two reported deaths.
Although the makers of Intergel have attempted to downplay the
problems with their product by blaming injuries on physicians''
"off-label use" of the product, we have uncovered evidence indicating
that there were major problems with the manufacturing process used to
make Intergel. In fact, an FDA inspection of the company that
manufactured Intergel revealed no less than 11 violations of medical
device Federal Regulations. Many of these violations were extremely
serious and could have negatively impacted the sterility and integrity
of the product. A January 6, 2003 warning letter to the company
indicated that all Intergel was "adulterated" and threatened an FDA
initiated recall if the problems were not remedied. Two months later
the product was recalled to allegedly examine injuries caused by
"off-label uses."
I have been told by some of my clients that members of this Newsgroup
may have also had Intergel used in their surgeries and suffered
problems.
If anyone is interested in obtaining further information concerning
our case, please feel free to call me.
Stuart C. Talley
Kershaw, Cutter, Ratinoff & York, LLP
980 9th Street, Suite 1900
Sacramento, California 95814
tel. 916-448-9800
fax. 916-669-4499
www.kcrylaw.com
Jeff - 15 Mar 2005 15:37 GMT
hey, blood sucking lawyer, please back to the rock you crawled out of.
Jeff