Panacryl Suture FDA Recall
A Panacryl Suture FDA Recall was issued on March 27th, 2006 because of continued problems associated with Johnson & Johnson’s synthetic absorbable suture. The recall is believed to involve some 1,061,712 sutures that had been distributed on a domestic and international level.
A division of Ethicon Inc., Johnson & Johnson issued a customer notification letter on March 28th, 2006 detailing the specific nature of the recall, stating that the suture’s “unique absorption profile… could act as a foreign body so that surgeons should consider its use in specific situations.” In short, the Panacryl Suture had problems associated with body rejection in which it was seen as a foreign body and pushed to the surface of the skin. The truth of the matter is that “spitting sutures” (as it is typically referred) is but one of numerous complications leading to the voluntary Panacryl Suture FDA recall.
Panacryl Suture Complications
The Panacryl Suture was developed for use as an absorbable suture that could be used for postoperative wound healing, specifically in the case of orthopedic or general soft tissue surgery. It was designed in such a way so as to support an extended wound healing time of up to six months, after which it would absorbed by the body. However, a number of serious complications led to the eventual withdrawal of Panacryl Sutures from the market. Some of the more common complications included:
- Spitting Sutures: oftentimes the body saw the sutures as a foreign body and rejected them, forcing them to the surface of the skin.
- Tunneling: healthy tissue growth can be inhibited by miniature tunnels that may form around the incision marks made by the sutures.
- Suture granulomas: the sutures can cause a scar tissue buildup that develops into a sizeable bump underneath the skin.
- Failed absorption: if the sutures are not absorbed by the body after the wound is healed, the patient will require additional surgery to remove them.
- Infection: the Panacryl Suture has been associated with an extremely high rate of postoperative infection.
More often than not, Panacryl Suture complications have been found to affect the soft tissue of the lower abdominal area. Such complications could extend patient healing time by as much as a year.
Panacryl Suture Injuries – Manufacturer Liability
Johnson & Johnson and parent company Ethicon Inc. currently find themselves embroiled in a great deal of personal injury litigation associated with injuries caused as a result of the defective Panacryl Sutures. A former high-ranking medical official who spent 15 years with Ethicon and Ortho McNeil has made claims that he had warned the company about potential problems associated with Panacryl Sutures. He has told the courts that his complaints had fallen on deaf ears and eventually cost him his job. He claimed that it was not the first time he had objected to the marketing of a product (the Ortho Evra birth control patch and Intergel representing two such objections) that had eventually been recalled or the subject of serious defect concerns.
It is the responsibility of product manufacturers to ensure that their products are safe for public use or consumption. Failure to abide by such a policy is viewed as negligent and grounds for personal injury litigation should such negligence result in personal injury. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact Aylstock, Witkin, Kreis & Overholtz today at (844) 794-7402 to get information regarding your rights as a Panacryl Suture injury victim.