The recall was announced by the United States Food and Drug Administration (FDA) last year because the organization learned that patient's bodies were rejecting the sutures. Problems associated with the Panacryl sutures include a higher risk of infection, sutures not being properly absorbed, the body rejecting the suture and pushing it out to the skin's surface, scar tissue forming around the suture causing bumps under the skin, and tunnels forming around the incision area.
The majority of problems occurred in patients who had Panacryl sutures used in their abdominal area. Many of these patients required second surgeries to correct the problem by removing the sutures. Some patients experienced recovery times that lasted for up to a year.
Customers were notified of the recall by a letter sent on March 28, 2006. The FDA recalled all product codes, affecting 1,061712 units.
Ethicon's Panacryl sutures were popular because they were absorbed into the skin rather than being removed physically. They were considered strong and used for patients who required wound support for an extended period of time.
Panacryl sutures were made by Ethicon Inc., which is a division of Johnson & Johnson. Ethicon was also responsible for Vicryl sutures, another product that led to a number of lawsuits. Vicryl sutures were recalled in 1994 because they were contaminated due to a faulty sterilizer. That recall affected 3.5 million units of Vicryl sutures.
According to a report at World Net Daily (February 25, 2001), Ethicon knew about the problem with the Vicryl sutures but failed to notify the FDA or the public about the risks associated with the sutures. The FDA received an anonymous phone call about a problem at the Ethicon plant and sent out a surprise inspection team who discovered multiple violations of manufacturing practices.
Ethicon also pulled another product, Gynecare Intergel, off the market in the 1990s after women were harmed by the product when it was used during gynecological surgery. The gel was used to separate and protect tissues as they healed in order to prevent adverse reactions. However, Gynecare, a subsidiary of Ethicon, received reports of pain, internal scarring, and repeat surgeries after Gynecare Intergel was used. Of those patients harmed by Gynecare, three women died.
If you are experiencing serious side effects as a result of Panacryl sutures speak to a doctor to discuss your options.