The Short, Unhappy History of Intergel

Chaska, MNThe website for Lifecore Biomedical, Inc., a medical equipment manufacturing firm based in Chaska, Minnesota, boasts an "historical timeline" touting major events in the company's history. The first citation is from 1965, the year Lifecore (then known as American Medical Research) was launched. The timeline takes us through the company's name-change to Lifecore in 1987 as well as major medical milestones.

The first mention of Intergel -- one of the products Lifecore is famous for making -- comes in 1989. The citation for that year explains Lifecore was contracted to develop Intergel by Ethicon, a branch of pharmaceutical giant Johnson & Johnson. The plan was to sell Intergel through Ethicon's Gynecare division.

"As its name implies, Intergel is a gel-like substance that is literally "poured" into a woman's pelvis followed gynaecological surgery. The stuff consists of "an amber coloured, viscous solution of sodium hyaluronate, which has been ionically crosslinked with ferric ions" in Lifecore's words. Intergel is designed to aid the healing process, by preventing internal, post-operative scars (or "adhesions" in Lifecore lingo) from developing in women.

Lifecore's timeline follows the development of this important product. In 1995, Intergel was subjected to an "adhesion prevention clinical study" as Lifecore puts it. Further clinical studies followed, then in 1998, the product was rolled out in Europe by Johnson & Johnson.

Rollout in North America didn't proceed quite as smoothly. In 2000, the U.S. Food and Drug Administration (FDA) gave a thumb's down review to the drug. In the FDA's opinion, Intergel caused more problems than it solved. More specifically, it actually increased a woman's chance of infection following surgery.

The FDA's rejection was appealed. The FDA gave Intergel a second look and in 2002, decided to reverse course. The FDA approved Intergel for sale in the United States. This approval came with a strict caveat. The product had to contain a warning tag indicating that the FDA only considered it "reasonably safe".

Intergel's time in the spotlight was extremely brief; the drug was sold in North America for less than two years when its makers decided to withdraw it.

"Gynecare Worldwide, a division of Ethicon Inc., of Somerville, New Jersey, notified FDA that they are voluntarily withdrawing Gynecare Intergel adhesion prevention solution from the global market and are urging customers to immediately stop using this device," stated an FDA "MedWatch" bulletin from April 16, 2003.

"This product is intended to be used in open, conservative gynaecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions," explained the FDA. "Gynecare is conducting this voluntary withdrawal to complete an assessment of information obtained during post-marketing experience with this device, including adverse effects associated with off-label use in laparoscopy and non-conservative surgical procedures such as hysterectomy."

Apparently, the FDA had received over 100 reports of problems associated with Intergel, including three deaths.

"Gynecare has received post-market reports of late-onset, post-operative pain, and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence," read a 2003 letter Gynecare sent to physicians, urging them to yank the product from their medical cabinets.

The company that made Intergel is considerably less forthcoming; after listing its introduction in the European and North American markets, there's no mention on Lifecore's company timeline as to the unfortunate fate of this short-lived drug.