Citizens' Group Calls for Awereness: Sutures Suspected in Post-Operative Infections
by author Trudy Peskett

When 26-year-old Carole Carter had surgery in 1998, she never suspected she would be battling an unusual post-operative infection three years later. But the painful, oozing wound on her leg wouldn’t heal, even with repeated oral and topical antibiotics, and Dettol dressings.

About two per cent of people get post-operative wound infections, almost all of which are treatable, according to microbiologist Dr. Tony Mazzulli at Toronto’s Mt. Sinai Hospital. But in this particular case, even specialists couldn’t figure out what was wrong. As for Carole, she only wanted her life back. “I just find it really gross,” she told the Ottawa Citizen about her injury. “It looks like ground beef.”

Seeking answers, Carole’s mother, Robin Carter, began researching via the Internet. She discovered similarities between Carole’s case and American reports of people claiming to have received contaminated sutures. In 1994, about 3.6 million sutures were recalled by Ethicon, the largest suture manufacturer in North America and a US subsidiary of Johnson & Johnson; this resulted in a multitude of lawsuits from people who blamed their infections on tainted sutures. Carole got tested and discovered she had the same rare bacterium, called Mycobacterium fortuitum, as some of these victims.

Mycobacterium is undetectable by routine hospital tests; a specific test must be conducted, which is often why these infections go untreated. “If you don’t know to look for it, you would never know it’s there,” says Dr. Rebecca Irvine in a phone interview. Dr. Irvine, a medical examiner, pathologist and professor at the University of New Mexico, became interested in the issue of suture contamination when her father experienced a non-healing abdominal wound following surgery. After he later died in a car accident, it was discovered that he, too, tested positive for mycobacterium.

“Most wounds will heal by themselves, but these don’t,” she says. Other symptoms include inflammation and oozing discharge that may continue for months, even years. Once discovered, antibiotics specific to mycobacterium are the conventional treatment.

Sometimes surgical removal of the infection is necessary.

The Carters believe Carole received contaminated sutures, although Ethicon has refuted the possibility. But in June 1998—–five months after Carole’s surgery–Ethicon released a recall notice of 3,076 PDS II sutures, some of which the company says went to a Calgary hospital. However, because suture batch and box numbers aren’t marked on surgery reports, it’s nearly impossible to confirm this connection for Carole and others who have lingering questions.

Carole–now recovered physically but still suffering mental and emotional upset as a result of her ordeal–belongs to Canadian Suture Victims, a group of Canadians who believe they may have been affected by contaminated sutures. Since Robin formed the group two years ago, some 70 individuals have contacted her, and she believes there are probably more out there. Many people might not know they’re at risk.

In 2001, Johnson & Johnson issued yet another recall notice for 1.1 million sutures–Vicryl, Monocryl and PDS II–42,000 of which were sent to Canada. It is unclear how many were shipped back.

In a recall, following a letter of notice, unused product is pulled off the shelves and returned to the company. However, the procedure appears to be far from 100 per cent efficient. For example, according to the US Food and Drug Administration, only 25 per cent of those sutures recalled in 1994 were ever recovered. It is conceivable that many were unwittingly used in surgeries.

“I do think this is a serious problem,” Dr. Irvine says. “The recalls should have been dealt with a lot more seriously. Even if there is only a possibility of contamination, with things like sutures, you just can’t take risks.”

Robin suggests that having physicians mark on surgery reports which batch and box number of sutures were used would not only reduce the risk of using recalled sutures, but would also track the connection between sutures and their source of manufacture. At present, Canadian Suture Victims is exploring issues of legality.

For more information, contact Robin Carter at Canadian Suture Victims at 613-820-5166. Web site for the US-based Ethicon Suture Victims group: suturevictims.com.

Source: alive #248, June 2003