And yet the sutures remain an issue, because sutures that are supposed to disappear, are not.
It's a problem that quite literally, won't go away.
The Panacryl suture was introduced in 1999 as the latest breakthrough in absorbable suture technology. Absorbable sutures, or stitches in layman's terms, are most often used during internal surgery. A suture used on the exterior of the body, to close a skin wounds for example, can be easily removed at the end of the healing process. A suture used internally, however, would have to be removed by way of a second surgery, unless it was considered permanent (which is often the case in heart surgery). Surgery would not be required if the suture had the capacity to become absorbed by the body naturally.That's where absorbable sutures come into play. Originally made from sheep's intestine (catgut), today's more advanced products are made from synthetic materials that offer added strength and ease of use, lower cost, and are less toxic.
Panacryl sutures were introduced as a unique, braided suture that offered both absorbability, and enough strength and staying power to support a wound for up to six months. However, Johnson&Johnson notes on its web site (product information, warning #7) that it could take anywhere from 1.5 to 2.5 years to completely absorb.
Here's the problem; they don't seem to be absorbing, or have become the alleged source for painful infections for some. Most problems allegedly stem from surgeries that use the Panacryl suture in the soft tissue area of the abdomen, although it's strong enough to be used for tendon and ligament repairs.
Galene Haygood, of Kilgor Texas, had been having problems during intercourse, and her husband was complaining about something irritating him physically. That 'something' turned out to be a Panacryl suture, protruding from Galene's vaginal wall.
A suture from bladder surgery she had had, seven years ago.
Nancy Fried of Cleveland, Minnesota, experienced a similar occurrence of a stitch overstaying its welcome when her doctor pulled a Panacryl suture from an infected abdominal wound. She had undergone surgery in 2003 -- first for stomach adhesions, then for hernia repair, and suffered numerous abdominal infections throughout. Her doctor extracted a fine-inch length of suture, and identified the suture to her as the likely cause of her infections.
Further problems linked to the suture involve granulomas, which are bumps under the skin caused when scar tissue forms around the offending stitch. As well, sutures can be interpreted as a foreign object and could be rejected by your body, pushing the suture out through the skin. Sutures that migrate in this way have been known to be the source of additional problems.
It appears there have been concerns about the Panacryl sutures prior to the recall. The FDA was asked, presumably by a doctor, to issue a warning against the use of Panacryl sutures in gynecologic surgery, after a number of female patients experienced adverse reactions.
And a former Ethicon official allegedly warned his employer about potential problems with the Panacryl suture, but his concerns were ignored.
As of March 2006, when the recall was issued, 1,061,712 Panacryl sutures had been sold and distributed globally.
If you've had surgery -- recent or otherwise -- contact your physician to determine the type of sutures used. This is especially important if you have experienced infections, or other symptoms identified above.
A suture designed to pull a disappearing act, may not have done its job.