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PANACRYL SUTURES
by Jane Mundy
Panacryl sutures are absorbable stitches, intended to be absorbed by the body so there is no need for removal at a later date. The Panacryl suture is made from a specific type of synthetic braided absorbable material and was used for orthopedic and general soft tissue surgery.
Absorbable sutures are designed to help speed the healing process. A suture, also known as a 'stitch', is a piece of thread that holds skin, internal organs, blood vessels and all other tissues of the human body together, after they have been severed by injury or surgery. They must be strong, flexible, and sterile.
Absorbable sutures are made of materials which are broken down in tissue after a certain time - from 10 days to four weeks, depending upon the type of suture. Panacryl sutures supposedly had the ability to support a wound for up to six months; they were considered a unique product for their combination of absorbability and strength -- but they didn't always absorb.
Panacryl sutures have done more harm than good to many patients by not dissolving as intended. On February 16, 2006, the FDA initiated a recall of 1,061,712 sutures which were distributed nationwide and internationally. Just over a month later, the manufacturer Ethicon Inc., a division of Johnson & Johnson, voluntarily recalled its sutures, stating that: "The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations." The company now faces liability lawsuits similar to a product it sold more than a decade ago. In 1994, Ethicon was sued after 3.5 million packages of its Vicryl brand of sutures were recalled--the sutures were contaminated due to a faulty sterilizer.
In December of 2006, Dr. Joel Lippman, chief medical officer at Ethicon, (and now whistleblower against Ethicon and Johnson & Johnson) objected to the release of its Panacryl sutures. He was subsequently fired for "inappropriate action." In his lawsuit against the company, Lippman says he objected to the release of the Panacryl suture, "whose use resulted in numerous adverse events."
Some of these adverse events include:
- Non-absorption by the body;
- Suture granulomas (a bump under the skin, as a result of scar tissue forming around the suture);
- Suture "spitting" (spitting sutures occur when the suture is pushed out to the skin surface by the body rejecting the suture);
- Extremely high rate of infection;
- Tunneling (tiny tunnels form around the incision area caused by the suture inhibiting healthy tissue growth. This looks like miniature mole tunnels at or about the incision site where the Panacryl sutures were used).
If you had surgery that required sutures and are still experiencing abnormal pain at the site of the surgery, ask your surgeon if Panacryl absorbable sutures were used. You may required another surgery to have them removed and then you may want to contact a lawyer.
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