Panacryl Sutures: Another suture experiment brought to you by Ethicon

Pittsburgh, PAEthicon Inc. has much to answer for. It is facing an undisclosed number of lawsuits from patients who have suffered or died because of alleged suture failure, the most recent wave of lawsuits relating to the absorbable Panacryl suture.

Now a Pennsylvania jury has awarded $15 million damages to a victim's family because another Ethicon surgical device—a cutter-stapler—failed.

Panacryl sutures were voluntarily recalled by Ethicon Inc., a division of Johnson&Johnson, on March 28th, 2006, after a significant number of mostly abdominal surgery patients suffered terribly from the sutures that just wouldn't go away.

Panacryl sutures were advertised as able to retain their strength for six months before being absorbed by the body. But in some cases, they were never absorbed by the body, or they messily disintegrated. In either case, the sutures became infection laden foreign bodies. Many patients had to go through repeated operations to clear out infected tissue long after their initial operations. The Panacryl suture remnants were rejected, even through the skin in some cases, or they formed granulomas, that is, lumps of unabsorbed suture material mixed with and surrounded by scar tissue.

Ethicon has defended its product (despite the recall), and blames the problems on surgical errors.

Ethicon's Vicryl sutures made it into the news in 1994 when a large quantity of sutures marketed under this name had to be recalled because of contamination at the company's manufacturing facility.

But Panacryl and Vicryl are not the only Ethicon products connected with post-surgical trauma, infection and death.

On May 27, a jury in Pittsburgh awarded $15 million to the family of a woman who died following gastric bypass surgery at a Pittsburgh hospital. The Ethicon Endo-Surgery Inc. cutter-stapler (a suturing tool used instead of needle and thread to bind tissue together during an operation) failed to form properly closed staples. The result was that her stomach contents leaked into her intestinal cavity, and she died.

In the Pennsylvania case, Ethicon tried to blame the surgeon for the staple failure, saying that an improperly sized staple had been used. But the jury decided that the Ethicon cutter-stapler had a design defect—although it allowed for different sizes of staples to be used, in fact surgeons have no way to accurately determine stomach tissue thickness when choosing which size of staple to use in the device.

Ethicon started to manufacture the stapler in 1999, the same year that Panacryl came onto the market.

The Panacryl lawsuits currently going through the courts or ending in settlements tell the stories of patients who went through prolonged pain and suffering. Their surgeons had no idea that these patients might as well have volunteered to be part of a clinical trial for an unproven suture product.

Medical history books say that humans have been experimenting with sutures to close wounds for at least 4000 years. Archeological records show that the ancient Egyptians used linen and animal sinew to close wounds. In ancient India, surgeons used the heads of beetles or ants to effectively staple wounds shut. The live creatures were affixed to the edges of the wound, which they clamped shut with their pincers. The insects' bodies were then cut off, leaving the jaws in place.

It was an Islamic surgical genius, Abu al-Qasim, living in Spain at the end of the 10th century, who first thought of using catgut (made from the intestines of sheep and cattle) not just for stringed musical instruments but also for surgical sutures. He discovered that catgut would dissolve naturally after his pet monkey ate the strings of his lute.

The human drive to improve surgical methods and equipment is a wonderful thing. The problem comes, however, when devices and new suture materials like Panacryl are hurried onto the market only to cause injury and death when they don't live up to their advertising.