Gynecare Intergel Solution was originally formulated to assist in the post-operative environment to ward against the development of adhesions after pelvic surgery. Adhesion, in lay terms, is the formation of scar tissue that can cause internal organs to
bind to one another after surgery. Adhesions are common occurrences in the majority of women following pelvic surgery - but can also occur in association with pelvic inflammatory disease (PID), endometriosis, and sexually transmitted disease.
Adhesions can be painful, and have a distinct impact on a woman physiologically. For example, 74 per cent of all bowel obstructions in women are thought to be caused by adhesions. They're also a leading cause of infertility, accounting for 15-20 per cent of infertility cases.There can be pain during sexual intercourse, and.... the list goes on.
Little wonder then, that Johnson&Johnson and its subsidiary, Ethicon, set out to develop a response to the issue of adhesions. The development of Gynecare Intergel Adhesion Prevention Solution was also a perfect fit for its new, pioneering women's health division, which made its debut under the Ethicon banner in 1997.
It seemed like a great idea at the time. However in what seemed, in hindsight, to be a premonition of things to come, the FDA initially turned down the manufacturer's application for the drug, citing in its' findings that the drug increased the risk and occurrence of infection in women.
Lifecore Biomedical, the company manufacturing Intergel on behalf of Ethicon, appealed the ruling. Upon a second hearing the FDA approved Intergel in 2001, but added that in its view the drug was 'reasonably safe'.
Ironically, less than two years later, Gynecare Intergel Adhesion Prevention Solution was voluntarily recalled by the manufacturer after a litany of complaints flooded into the FDA, including reports of three deaths linked to its use. Literally two years after the product was approved with some reservation by the FDA, the Gynecare Intergel solution was off the market. A year later, the FDA Centre for Devices and Radiological Health slammed Lifecore with allegations of misbranding and failure to provide documents pertaining to eleven specific reports of serious injury, or death.
What complicates the issue is the apparent off-label use of Gynecare Intergel in surgeries for which it was not approved. In other words, Intergel was expressly approved for open gynaecological procedures, but there were never approvals for hysterectomies, or laparoscopic procedures. And it is the unapproved use of Intergel, apparently, that lay at the root of most (but not all) of the issues relating to problems with the product.
It can be suggested that the reason for the FDA rant against the manufacturer in 2004 over misbranding, was the alleged misinformation that may have been responsible for surgeons using Intergel incorrectly.
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Nonetheless, a product approved for public consumption carrying a grave reservation (and yanked off the market 18 months later) suggests that tougher policies for the FDA are overdue, if not too late for those women who have died, or whose health have been negatively compromised by inappropriate use of Intergel.Looking back, it appears that the FDA had the right idea all along in denying Lifecore Biomedical in the first round of approvals. While the appeals process is a stroke of democracy, a product found to potentially put human beings at risk should never have been approved at all, appeals notwithstanding.
The black warning of 'reasonably safe' could have served as a dose of reality, and the omen it played out to be.
Three lives could have been saved in the process.
