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FDA Approves New Antiadhesion Treatment For Gynecologic Surgery.(Brief Article)
2001 DEC 13 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has approved a solution that surgeons can use to help reduce postoperative surgical adhesions in women undergoing open gynecologic surgery. Adhesions (scars) are an undesirable clinical consequence of gynecologic surgery.
The product is Gynecare Intergel Adhesion Prevention Solution, manufactured by Lifecore Biomedical, Inc., of Chaska, Minnesota. FDA approved the solution based on a review of clinical studies of safety and effectiveness conducted by Lifecore.
A randomized trial inolving 281 women undergoing certain types of open gynecologic procedures at 16 medical centers in the United States and Europe compared the Intergel solution with standard irrigating solution.
The results showed that use of the Intergel solution was reasonably safe and was associated with a lower rate of adhesions than the standard treatment. Patients who received Intergel had approximately one less adhesion overall than those who received the standard solution, and there was a reduction in the number of women with moderate and ...
- FDA approves new anti-adhesion treatment for gynecologic surgery.
- Press release article from: M2 Presswire November 20, 2001 700+ words
...is approved for open gynecologic surgery, it is not approved...studies in which the Intergel solution was applied during gynecologic surgery performed through a...patients treated with the Intergel solution than in those who did...
- Gynecare voluntarily withdraws Intergel Solution from market.
- Newspaper article from: Medical Device Daily March 31, 2003 700+ words
...Gynecare voluntarily withdraws Intergel Solution from market A Medical Device...Solution (brand-named Intergel Solution), that it licenses from...surgical techniques, not the Intergel Solution. The Intergel product made...
- Lifecore Reports Laparoscopic INTERGEL Solution Pilot Clinical Trial Results
- Press release article from: PR Newswire June 9, 1998 700+ words
CHASKA, Minn., June 9 /PRNewswire/ -- Lifecore Biomedical, Inc. (Nasdaq: LCBM) announced today that it has completed the analysis of pilot human clinical trial data involving the use of INTERGEL(TM) Adhesion Prevention Solution in 50 female laparoscopic abdominal surgery patients. Patients treated
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- Magazine article from: Women's Health Weekly Henderson, C. W. January 25, 2001 700+ words
...cost-effective anesthetic for gynecologic surgery than its cousin remifentanil, despite...general anesthesia for outpatient gynecologic surgery," Anesth Analg, December 2000...cost-effective anesthetic for gynecologic surgery than its cousin remifentanil, despite...
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...cost-effective anesthetic for gynecologic surgery than its cousin remifentanil, despite...general anesthesia for outpatient gynecologic surgery," Anesth Analg, December 2000...cost-effective anesthetic for gynecologic surgery than its cousin remifentanil, despite...
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...analgesia (IV PCA) when used after gynecologic surgery. This needle-free system for...women in the study who had undergone gynecologic surgery. Patients received either IONSYS...relief to most patients undergoing gynecologic surgery without the needles, lines, and...
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- Magazine article from: Family Practice News Johnson, Kate November 1, 2005 700+ words
...women should not be denied major gynecologic surgery solely on the basis of their presumed...among elderly women undergoing major gynecologic surgery is relatively high, compared with...morbidity associated with major gynecologic surgery in their age group. However, with...
- Neuropathy found rare after gynecologic surgery.(GYNECOLOGY)(Clinical report)
- Magazine article from: OB GYN News Ault, Alicia July 1, 2009 700+ words
...The incidence of neuropathy after gynecologic surgery appears to be fairly low, based...enrolled 642 patients who underwent gynecologic surgery. The most common procedures were...relatively rare in patients undergoing gynecologic surgery (at 1.9%), and that there...
