Ethicon has investigated the reports of foreign body reaction in the presence of panacryl suture. This investigation included: a review of complaint history and trends, a review of pre-clinical state, a literature search and review, and a comparative tissue reaction study. The tissue reaction study was a ninety-one day study designed to assess and compare tissue reaction of single and looped panacryl suture (a long term absorbable suture) to single and looped braided non-absorbable suture. The tissue reaction to all four suture groups was comparable to each other. For both the single and looped test articles, the reaction was typical for implanted suture material and consisted of an initial minimal to moderate sub-acute inflammation which gradually changed with time into a minimal to mild chronic foreign body reaction. The combined results of this investigation indicate that there is no one indicator that suggests panacryl suture should elicit a greater tissue reaction than other absorbable suture.

It was reported a patient had an abdominal procedure performed through a mid line anterior abdominal wound. The wound was closed with sutures. The patient presented with discharge from the lower end of their mid line incision. Examination revealed a sinus track with discharge of purulent material. The diagnosis of a stitch granuloma was made. Patient was subsequently taken to the operating room and underwent exploration of their mid line wound. At surgery, the suture was noted to be intact. Extensive granulation tissue had formed around the suture with the suture material running in a "granulation tunnel". The surrounding tissue was quite hard with and intense fibrotic reaction. The suture line was revised with excision of the granulation tunnel and scar tissue.

H-6 conclusion: no conclusion can be drawn at this time. Should further information be obtained, a supplemental 3500a will be submitted accordingly.