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WASHINGTON (AP) – US health authorities on Tuesday suspended the sale of a type of surgical sieve used to repair pelvic conditions in women, after years of patient reports of injuries and complications due to complications. implants.
The Food and Drug Administration ordered the two remaining manufacturers of the mesh – Boston Scientific and Coloplast – to stop selling it immediately, saying the companies had not demonstrated that the mesh was safe for long-term use. Several other major manufacturers, including Johnson & Johnson, had previously stopped making the mesh.
The FDA's action does not apply to surgical meshes used to treat other conditions such as hernias or incontinence.
Boston Scientific said that she was "deeply disappointed" by the agency's decision "severely limiting treatment options" for women. Coloplast, based in Denmark, declined to comment.
Women who have reported pain, bleeding and device-related infections have been filed by tens of thousands of lawsuits against mesh manufacturers. In some cases, the mesh can move, which can puncture internal organs or the wall of the abdomen. These problems sometimes require several surgical procedures to remove or reposition the mesh.
Beginning in the 1990s, gynecologists adapted the surgical mesh to treat pelvic collapse in women, which can lead to slippage of the bladder or reproductive organs, causing pain, constipation and urinary problems. The FDA first approved the mesh specifically for this purpose in 2002 and manufacturers advocated mesh as a way to speed up patient recovery time compared to stitch surgery.
But the FDA has received thousands of reports of injuries and issued a series of warnings. In 2016, the agency reclassified the mesh as being high risk.
The agency said Tuesday that women with pelvic mesh should continue regular checkups. There is no need to remove the mesh if the patients do not have any problems or symptoms. The FDA order applies to the stitches inserted into the vagina with a small incision and not to the stitches inserted into the abdomen with a larger incision.
In the United States, about 1 in 8 women undergo some form of surgery to treat pelvic collapse problems, according to the FDA. The regulators said that the use of the mesh targeted by their last action had decreased in recent years for security reasons.
Pelvic mesh is the latest medical device for women to have security problems long after their approval. Last year, the FDA imposed significant restrictions on the Essure birth control implant, linked to allergic reactions, pain and bleeding. Its maker, Bayer, then removed it from the market. Previously, the FDA had warned against the use of a surgical tool to remove uterine fibroids because it could spread cancer inadvertently.
Like most medical devices on the market, the FDA has approved the pelvic mesh through a regulatory procedure that reviews new products based on their similarities to devices already existing in the market, rather than new ones. tests on patients.
Last November, the FDA announced its intention to reorganize this system so that medical devices use more modern technology.
Larry Biegelsen, an analyst at Wells Fargo, said in an investment note that Boston Scientific's two pelvic mesh products generated about $ 25 million in 2018, less than a fraction of its annual sales.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.
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