Intergel sales halted pending investigation of deaths, pain. (Antiadhesion Treatment).

The marketer of Intergel Adhesion Prevention Solution, an antiadhesion treatment for gynecologic surgery, has ceased its sale pending an investigation of reports of pain, repeat operations, and three deaths among women who received it.

The Food and Drug Administration is also investigating the reports.

Gynecare Worldwide, a division of Johnson &Johnson, voluntarily withdrew the product from the international marketplace and has notified physicians to immediately discontinue its use and return unused products and samples to the company. The solution is manufactured by Lifecore Biomedical Inc. of Chaska, Minn.

Physicians received a letter from Gynecare saying that the reported problems were associated with off-label use in Iaparoscopic and nonconservative surgical procures, and in some indicated uses. Intergel is approved for use only in open gynecologic procedures and is not intended for use in laparoscopic surgery. Studies on laparoscopic application failed to demonstrate effectiveness and also showed higher infection rates in patients treated with Intergel than in those who did not receive the product, according to the FDA.

Lifecore Biomedical's product information specifically states that Intergel has not been proven safe and effective in laparoscopy or in hysterectomy.

The deaths under investigation resulted from infection and have not been specifically tied to the use of Intergel, said Jackie Russo, public ...