Ethicon's Sutures: Post-Operative Nightmare

Kenner, LAIt has been a hell of a year for Lisa Johnston. In May of 2006, she went into the hospital for what she believed would be routine surgery, requiring 5 weeks of recovery. One year and two major surgeries later, she is in chronic pain and just beginning to pick up the pieces of her life.

"I feel lucky to be alive," Lisa Johnston (not her real name) says. "The infection almost killed me."

Lisa's surgeon used Vicryl sutures, which he believed at the time to be safe. Much like Panacryl sutures (and both made from Ethicon Inc., a division of Johnson & Johnson), patients are now coming forward to report serious post-surgery complications including infection, granulomas, and so called "spitting" sutures, where the body perceives the sutures as a foreign body and rejects them, forcing them to the surface of the skin. In many cases, additional surgeries were necessary to remove the infected sutures.

Vicryl and Panacryl Recalls
What Lisa's doctor didn't know was that in 1999, a Vicryl recall had been issued due to contamination. But according to the FDA, only 25 percent of the recalled sutures were recovered -- and some may still be on hospital shelves today. Ethicon, Inc. distributed at least 3.6 million packages of contaminated sutures to the public through medical supply distributors, hospitals and physicians.

Lisa believes her sutures were among those contaminated sutures that were never recovered during the recall.

On March 27, 2006, the FDA also required Ethicon, Inc.to recall Panacryl sutures due to continued problems. The recall is believed to involve more than one million sutures which had been distributed throughout the United States and internationally.

Life-Threatening Infection
Five weeks after her surgery, just around the time she was schedule to return to work, Lisa developed a fever of 105 (F), as well as "spitting" sutures, swelling and pain. The diagnosis: severe infection requiring immediate surgery. "We thought I was going to die," says Lisa.

"The surgery was supposed to take two hours. It took five. The doctor found that every single suture had crystallized and the areas had become infected. He had to remove every suture and do it all again, but this time with no internal sutures."

Lisa returned home, covered in external sutures, looking "like I was covered with spiders." Over the next 3 weeks, she began to feel like she was slowly recovering. Then another health crisis struck.

A Third Surgery
"In the third week," Lisa recalls, "I developed a knot, called a granuloma, in the left side of my abdomen. The doctor went in again and took a tissue sample. When it was studied, they found that it contained a rare strain of bacteria. The doctor said there were no known cases of it internally."

Physicians rushed to save Lisa's life, prescribing super-antibiotics delivered 24-hours a day through an intravenous drip that "mainlined" the antibiotics directly to her heart. With her life hanging in the balance, Lisa drew up her will. "I didn't think I would get through it," she says.

After six weeks of the antibiotic drip and home health care, Lisa was healthy enough to go under the knife -- again. The surgeons took out a massive granuloma. It turned out to be an infected suture that had been missed in the second surgery.

Blood Clot Nightmare
Not long after the surgery, Lisa passed out and was rushed again to the hospital with a blood clot in her left leg. "The doctor said it was the size of his thumb, and they just kept saying 'Don't move'.

"I thought: 'This is it.'"

Lisa was hospitalized for nearly two weeks and prescribed a regime of antibiotics and blood thinners that she may have to take for the rest of her life.

She describes her time in the hospital as "like a nightmare...an emotional rollercoaster. My 10-year-old daughter was so afraid. Coming home from school she'd say to herself 'I hope Mom's okay.' Because there were many times when she would come home and be taken straight to the hospital, because we weren't sure if I was going to make it."

A Year Later
A year after her initial surgery, Lisa is back at work and looking to the future. But she remains haunted by chronic pain. "There isn't a day that goes by that it doesn't burn or hurt, and my entire stomach is numb. The doctor says it's nerve damage."

The past year has taken a toll on Lisa, and on her family. "My husband had to take a lot of time off of work. And the medication, even with my insurance, has cost thousands, because many times we couldn't use generic versions. And there's the fear. With a blood clot, you never really know."

Lisa is concerned about regulation, and believes that her health crisis could have been prevented if there was better monitoring of medical manufacturers. "It upsets me that the FDA [may not be] paying attention to these companies." She wonders, like many of us, how could this happen here?

"The hardest part is knowing that these companies... the worst thing that will happen to them is a lawsuit or a fine. But they could pay out millions and it won't change the reality of my everyday life.

"I have to live with this forever."