The U.S. Food and Drug Administration (FDA) recalled Panacryl Sutures on March 27, 2006 because of ongoing problems with the sutures. Customers were notified via letter sent by Ethicon Inc., on March 28th, 2006. The problem was that patient's bodies allegedly saw the Panacryl Suture as a foreign body and were rejecting it.
Problems with Panacryl Sutures allegedly include: higher risk of infection, sutures not absorbing properly, bumps under the skin where scar tissue formed around the suture, tunnels forming around the incision area, and the suture being pushed out to the skin's surface because body rejected the suture.
Panacryl Sutures were notable because they did not have to be removed from the body; they were simply absorbed into the skin. They were used in soft tissue surgeries such as tendon repairs and were also marketed as useful in situations in which wound support was needed for up to six months.
At least one high ranking Ethicon official has come forward saying that he warned Ethicon about problems with the Panacryl Sutures. The official, who was Chief Medical Officer at Ethicon and also held high ranking positions at other Johnson & Johnson subsidiaries, says he warned Ethicon about the numerous adverse events associated with Panacryl Sutures and asked them not to release the sutures. Ethicon ignored his warnings and released the sutures only to have them recalled in 2006.
According to the FDA website, the sutures are composed of lactide and glycolide. All Panacryl suture products codes were recalled, with 1,061,712 units on the market. Panacryl sutures were approved by the FDA in 1999 and were marketed by Ethicon Inc., a division of Johnson & Johnson.
In many cases patients who experienced negative effects because of Panacryl sutures required corrective surgery. If a doctor used Panacryl sutures in your surgery and you have suffered serious side effects from the sutures, you should contact a lawyer to discuss your options.