pIRS

possible Intergel Reaction Syndrome (pIRS)

We have decided to initiate research into "possible INTERGEL REACTION SYNDROME" (pIRS). The goal of this work will be to gather information concerning the best strategies for treating people with pIRS. We hope to share this information with a panel of experts with view to making recommendations to patients concerning treatment for their condition.

In the initial stages of this work, we want to hear from anyone who may have experienced pIRS. We are particularly interested to hear about the therapy you have received. This will enable us to construct a more formal questionnaire.

Please send email to david.wiseman@adhesions.org with brief details of when you received Intergel, the type of procedure in which it was used and the reactions you may have experienced.

Background

On March 27 2003, Johnson & Johnson (J&J, with its manufacturing partner Lifecore Biomedical - LCBM) voluntarily withdrew the anti-adhesion product - INTERGEL - from the market pending an investigation into the circumstances surrounding some adverse events including post-operative pain and inflammatory reaction. There were also two deaths where the product had been used after the accidental puncture of the bowel. A third death has also been discussed in various company communications. FDA has also announced an investigation concerning this matter.

These investigations are still ongoing. According to estimates provided by J&J, there have been 200-300 people affected by pIRS.

We have been contacted by a number of patients who may have experienced pIRS seeking advice on how best to treat the condition. Because there is no centralized source of information for them, we have decided to initiate this effort.

Please note that since the cause of the alleged reactions to INTERGEL has not yet been determined, we are calling this "possible INTERGEL REACTION SYNDROME". We are aware of a number of lawsuits regarding this matter and wish to point out that our effort here is independent of any final determination as to cause or liability. Regardless of where one stands in any lawsuit, surely everyone can agree that the patients' welfare must come first.

Our goal is merely to gather and provide information to patients who may have suffered from pIRS, in the most rapid manner possible. We therefore welcome the collaboration of all those interested in the welfare of INTERGEL patients.

Accordingly, we have requested J&J to provide more information on the proper treatment of patients who may have suffered pIRS. In addition to financial support, we have also requested any information, however seemingly trivial, from their research that may help to devise the best treatment for these patients.

To see our previously posted information below on this subject.

INTERGEL Withdrawn from Market by Company

GYNECARE Voluntarily Suspends Marketing and Sales of Anti-Adhesion Product Pending Evaluation of Postmarketing Events

Gynecare (division of Johnson & Johnson) have voluntarily withdrawn the anti-adhesion product - INTERGEL - from the market pending an investigation into the circumstances surrounding some adverse events including post-operative pain and inflammatory reaction. There were also two deaths where the product had been used after the accidental puncture of the bowel. The relationship between the product and these events is not certain, but the company are investigating it.

WHAT TO DO IF YOU THINK YOU HAVE HAD SIMILAR REACTIONS

The IAS has been contacted by a number of patients who have asked us what to do if they believe they have had a reaction to Intergel. Gynecare (a division of Johnson & Johnson - the marketers of the product) have kindly provided us with the following announcement:

"If you have had Intergel used during a surgical procedure and have any questions about it or believe you have had a reaction to it, you may contact Gynecare directly by dialing 877-384-4266, option 1. This number will connect you with a Registered Nurse who is trained to respond to your call."

You may also contact your own doctor who will make a report to the company, since this information will be useful to them in determining the cause. (If you do contact the company, let your doctor know this so that s/he can inform the company). You can let us know too if you wish.

For more information you can read the following press releases (PDF), as well as a copy of the letter sent to doctors (PDF) and the FDA Safety Alert.

E-mail david.wiseman@adhesions.org for further details.

To Top