(Reuters) – On Tuesday, the US Food and Drug Administration ordered transvaginal surgical implant manufacturers to halt US sales and distribution immediately, the latest agency action to address unit-related security issues. FDA said Boston Scientific Corp. and Coloplast A / S did not show a reasonable assurance about the safety and efficiency of these units in their premarket applications. Companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said in a statement.
In 2016, the agency reclassified the network as class III or high risk, requiring its manufacturers to obtain approval from the FDA's most stringent entity's pathway to continue selling the products.
The device, made of synthetic or biological material, is usually implanted in women to repair weakened or damaged tissue and to support pelvic organ prolapse. The depression occurs when the muscles and tissues supporting the pelvic organs ̵
Boston Scientific and Coloplast are the only companies still selling and distributing networks for this use, the FDA told Reuters.
Boston Scientific said it was "deeply disappointed" by the FDA's decision and will work with the e-agency to determine the next step.
"The inaccessibility of these products will severely limit the treatment options for the 50 percent of women in the United States who will suffer the pelvic organ prolapse during their lives," the company said in an email statement.
Coloplast said the order included only one of its products, which corresponds to about 0.2% of total revenue. The Danish company refused to comment further.
Thousands of lawsuits have been filed in recent years against medical device manufacturers claiming that their transvaginal net implants caused pain, perforations, urinary problems, bleeding and other injuries. The lawsuit was filed against Boston Scientific, Coloplast, Johnson & Johnson and CR Bard, now a unit in Becton Dickinson and Co.
J & J said it has not sold its network product since 2012.
Other companies have to remove their products from the market last year because they did not submit claims for prior market approval applications, the FDA said.
Much of the $ 929 million of Boston Scientific's legal reserves at the end of 2018 was related to the company's Needham and S&I analyst Mike Matson said these products accounted for about 1% of corporate revenue.
The Boston Scientific shares were 4% lower to $ 36.24 in late afternoon trading.