Gynecare Intergel Approved for Adhesion Prevention
By Anthony M. Frasca, M.D.
May 16, 2002 - Times Beacon Record p. B11
Port Jefferson resident, Augusta Sisler, local advocate for the International Adhesions Society (IAS), is spreading the news of the recent Food and Drug Administration (FDA) approval of Gynecare Intergel. The product, which is used to prevent the formation of intestinal adhesions, is a viscous solution that is used to coat the interior of the abdomen following surgical procedures. The product is being used to prevent severe post-surgical adhesions in patients undergoing uncomplicated gynecological surgery.
It has been a struggle for LifeCore Biomedical to obtain FDA approval for its product
Interget. In January of 2000, the product was denied approval for use in the United States based on a recommendation of the FDA's General and Plastic Surgery Devices Advisory Panel. The advisory panel was not convinced that the product was beneficial in reducing adhesions. The number, severity and extent of adhesions were not significantly different between patients who were treated and a control group. Of note was the panel's concerns about the infection rate reported in the studies. In the study, 4.4 percent of patients who received Intergel after laparoscopic surgery had wound infections as opposed to 0.0 percent in a control group.
LifeCore challenged the FDA's denial on the basis that Intergel was beneficial in preventing severe adhesions and that the infection rate was not statistically significant. The issue was sent to a newly formed FDA dispute resolution panel. The dispute resolution panel was set up under a 1997 FDA reform law to give medical device makers a way to challenge product rejections. The panel heard testimony from David Wiseman, Ph.D., founder of the
IAS, and from Augusta Sisler, volunteer coordinator for the New York area. Sisler and Wiseman provided information to the panel about the significance of post-operative adhesions and potential impact of anti-adhesion products on patients. In addition, LifeCore hired experts to present evidence that convinced the panel that the company's conclusions on the effectiveness of Intergel were sound.
|Photo Caption: Augusta Sisler of Port Jefferson recently met with State Senator Kenneth P. LaValle to promote greater awareness of Adhesion Related Disorder
(ARD). Adhesions are the number one complication of surgery. The Adhesions Society, a volunteer organization, promotes awareness and research into
ARD, as well as support and information for patients.
LifeCore's strategy was effective. In September, 2001, in its first ever vote, the dispute resolution panel unanimously agreed to urge FDA regulators to approve Intergel. The FDA relented, however, and it approved the product with stringent indications. Intergel is indicated for use in patients undergoing open, conservative gynecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. The narrow indications spelled out by the FDA hardly matter.
Although it is illegal for a drug or device manufacturer to promote a product for indications that are now approved by the FDA, under federal law, doctors can prescribe any treatment they believe is best for their patients. Therefore, surgeons may use Intergel in any way they deem applicable to an individual patient.
Intergel, and any other product that deals with adhesions is important because it addresses a common, but obscure problem related to surgery. Post-surgical adhesions are a serious, insidious complication of many abdominal surgeries. Adhesions are the most common complication of surgery, more common than wound infections. Thirty-three percent of all pelvic pain in females is caused by adhesions. Fifteen-20 percent of female infertility is caused by post-surgical adhesions. There are at least 400,000 adhesolysis procedures annually in the United States, resulting in $1.6 billion in medical expenses. Hospital admissions for adhesion related disorders rival the number of hip replacements, heart bypass operations and appendectomies.
Individual emotional trauma adds to the medical expense of the disease. Sisler has undergone numerous abdominal surgical procedures as a result of post-surgical adhesions. It has taken a toll on her personal and professional life. In addition to chronic pelvic pain, there is the constant threat of bowel obstruction from scar tissue.
To her credit, Sisler has attempted to increase awareness of the disease by education and participation in local and national organizations dealing with the issue. The seriousness and occasional desperation of patients stricken with adhesions is exemplified by the willingness of the IAS to speak out on behalf of a product that may only have marginal effectiveness. The working theory is, if it helps even one person avoid the trauma that many others have suffered, it is worth it.
It is too early to tell what the future of Intergel will be and whether it will help patients afflicted with adhesive disorders. However, one thing is certain, the IAS will not stop until the public, legislators, and researchers are educated and aware of adhesion related disorders. The reason is a little known, sobering statistic; one out of three women undergoing gynecologic surgery will have nearly two hospital admissions over the next 10 years for adhesion related disorders.
Sisler said she supported the approval of Intergel "to help bring about any solution that would help adhesion sufferers."