WASHINGTON (AP) — a product commonly used in surgery to treat incontinence and other women's health issues cause more complications than previously thought and probably shows patients to unnecessary risks, according to U.S. health officials.
The Food and Drug Administration said Wednesday that women who have a surgical mesh size implanted to support their reproductive organs are at greater risk of pain, bleeding and infections than women who have traditional surgery with stitches.
-The additional advantage of using the net is not but it really seems to be an extra risk, "says Dr. William Maisel, FDA'S Chief researcher and Deputy Director of the Center for devices.
More than half a million women undergo surgery for pelvic cavities organ collapse, known as prolapse or urinary incontinence every year, although not all procedures imply mesh. About 75 000 women had prolapse surgery Panel is inserted through the vagina last year and more than 200 000 women had the procedure for incontinence. A less common procedure inserts meshes through the abdomen and the FDA said, there are significantly fewer complications with this technology.
Between 2008 and 2010, the Office received more than 1,500 reports of adverse events from women undergoing vaginal prolapse surgery with mesh, 500 percent from the previous three years. There were fewer complications among incontinence patients.
Wednesday's warning only applies to networks of prolapse. The Agency is also reviewing the use of urinary incontinence, although side-effects have not been as often. Doctors performing procedures say incontinence surgery uses smaller mesh, possibly resulting in fewer complications.
In a rare mea culpa, FDA scientists said a 2008 proclamation from the Office, called the issue "unusual" was wrong. After reviewing the medical literature over the last 15 years, appreciates the FDA is now the most common problems occurring in 10% of women within one year of surgery. These patients undergo several operations to remove nets.
Produced by half a dozen companies, used plastic mesh to strengthen pelvic cavities wall at stress incontinence and pelvic organ prolapse cavities, in which the bladder or other reproductive organs sliding down into the vagina. The mesh is inserted through the vagina, often with a small surgical cut. Many doctors prefer this method of abdominal position, requiring a larger cut.
Despite the high share of damage, said the FDA'S top unit scientist Government would not withdraw the authorisation for the product, because some patients may still benefit.
-Rather than deleting meshes from the market and do not have an important product that are available for these patients, what we would like to do is ensure that it is used in the proper patients, "says Maisel, in an interview with The Associated Press.
But patients who have suffered through mesh-related complications, say the device should be prohibited in all but the most urgent cases.
"It is not about finding a better patient, this is not to use this product unless there is no human tissue," said Lana Keeton, Miami resident who underwent 17 operations delete which was implanted in 2001. Keetons group, truth in medicine, has lobbied FDA about the dangers of mesh size in recent years.
FDA will hold a two-day meeting in September to discuss studies that would identify which patients will benefit most from mesh implant. Such studies usually take years and millions of dollars to implement.
For now, said Maisel surgeons should first consider traditional prolapse surgery, pelvic cavities, the word is moved and be reinforced with stitches. Get secure, say surgeons procedure has a failure ranging from 20 to 45 percent, which first led doctors to start using nets to try to strengthen pelvic cavities wall.
The most common side effects occur when the network is functioning correctly and not bond in its own way through the vaginal wall, which can cause infection, estimated difficulty and pain during sex.
Follow-up operations can involve two or three hospital care.
"It is not necessarily a simple procedure and sometimes the whole network cannot be deleted, says Dr. Jill Brown, a medical officer in FDA'S device review division.
Dr. Charles Rardin, associate professor at Brown University medical school, said he will continue to use the mesh, but mostly in cases where patients have failed traditional surgery.
Revaluation of surgical mesh, which FDA reviews the fast system to clean medical devices, which has been largely unchanged since the 1970s.
That 90 percent of medical devices sold in the United States, cleaning up the pelvic cavities networks under the FDA'S rapid system, which grants marketing authorization for 90 days to entities that are considered low risk.
Medical device manufacturers have spent the past year lobbying FDA and Congress to speed up the device approvals Government reviews process. They point out that European regulators approve many units faster than the FDA, leading some companies to launch their products abroad first.
Safety advocates say the Agency has over exploitation system, and clear the high-risk entities to more testing.
Dr. Diana Zuckerman said the Agency should have required the studies it is considering now before mesh products was approved.
"If they had had to go through more rigorous approval process, similar to that for prescription drugs, it would have been clear years ago that surgical mesh has more risks than benefits in many types of surgery," said Zuckerman, full-screen presentation the National Research Center for women & families.
FDA invited panelists at the meeting on the pelvic cavities septembers surgical networks should be reclassified as high risk material unit.
Surgeons began to use nets to repair hernias in the 1950s, and during the next 40 years the custom technology for women's health conditions. FDA cleared first mesh for prolapse in 2002, but since it was similar to the units that had been used for decades did not undergo human tests.
Manufacturers of pelvic cavities network include Boston Scientific Corp., Johnson & Johnson, Covidien plc, CR Bard Inc. and American medical systems.
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