March 28, 2003

Dear Director of Operating Room:

GYNECARE is conducting an urgent, voluntary global withdrawal of GYNECARE INTERGEL* Adhesion Prevention Solution, a device indicated for use in patients undergoing open, conservative gynecologic surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. You should immediately discontinue use of the device.

GYNECARE is conducting this voluntary withdrawal in order to complete an assessment of information obtained during post-marketing experience with the device, including adverse events associated with off-label use in laparoscopy and non-conservative surgical procedures (such as hysterectomy).

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. In some patients, a residual material was observed during the repeat surgery. The post-operative pain could be suggestive of other, serious complications and physicians should be aware of this in managing patients in the post-operative period.

GYNECARE is withdrawing the device from the market while we conduct a full and thorough assessment of technical issues, surgical techniques and circumstances associated with the post-market events. From the launch of this device in 1998 to February 2003, the overall complaint rate worldwide is low.

Your GYNECARE sales representative can assist you with returning product and answer any questions you may have. Or, you can call our customer hotline at 1-800-551-7683.

The U.S. Food and Drug Administration has been notified of this action.

Sincerely,
GYNECARE

*Trademark of Ethicon, Inc.