WASHINGTON (AP) – US Health Authorities on Tuesday stopped the sale of a type of surgical mesh used to repair pelvic conditions in women, after years of patient reports of injuries and complications from the implants.
The Food and Drug Administration ordered the two remaining producers of the mask – Boston Scientific and Coloplast – to stop selling it immediately, saying that the companies failed to show the network is safe for long-term use. Several other major manufacturers, including Johnson & Johnson, have previously stopped making the network.
The FDA act does not apply to surgical nets used to treat other conditions such as hernia or incontinence.
Boston Scientific said it was "deeply disappointed," by the agency's decision that the company said "would severely restrict treatment options" for women. Coloplast, based in Denmark, refused to comment.
Thousands of lawsuits have been filed against network manufacturers of women who have reported pain, bleeding and infection associated with the devices. In some cases, the network may replace the site, puncture internal organs or the abdominal wall. These problems sometimes require multiple operations to remove or reposition the network.
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But the FDA received thousands of damage reports and issued a series of warnings. In 2016, the agency reclassified the network as high risk.
The agency said Tuesday that women with the pelvis must continue regular checks. It is not necessary to have the mask removed if patients do not have problems or symptoms. The FDA order applies to masks inserted through the vagina with a small incision, not mesh inserted through the abdomen with a larger incision.
About 1 in 8 women in the United States undergo some form of surgery to treat pelvic collapse problems, according to the FDA. Regulators said the use of the network targeted to their latest action has been reduced in recent years due to security issues.
Pelvic mesh is the latest medical device for women to have security issues long after they were approved. Last year, the FDA placed major restrictions on the contraceptive implant Essure, which was associated with allergic reactions, pain and bleeding. Its manufacturer, Bayer, later withdrew from the market. Previously, the FDA warned against the use of a surgical tool for the removal of uterine fibroids because it could unintentionally spread cancer.
Like most medical devices on the market, the FDA approved the pelvic mass through a regulatory pathway that considers new products based on their similarities to decades old devices already on the market, rather than new testing in patients.
In November, the FDA announced plans to revolutionize the system so that medical devices would use more up-to-date technology.
Wells Fargo Analyst Larry Biegelsen said in an investment note that Boston Scientific's two pelvic mask products generated about $ 25 million in 2018, or less than a fraction of one percent of the company's annual sales.
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