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FDA Determines Boston Scientific Hasn't Showed Reasonable Assurance Of Safety, Effectiveness For Surgical Meshes

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FDA Determines Boston Scientific Hasn't Showed Reasonable Assurance Of Safety, Effectiveness For Surgical Meshes

Boston Scientific Corporation (NYSE: BSX) traded lower Tuesday after the U.S. Food and Drug Administration ordered the company to stop selling its surgical mesh products used for transvaginal repair of pelvic organ prolapse due to safety concerns.

What Happened

After thousands of lawsuits and complaints related to adverse effects of surgical mesh, the FDA said Tuesday  Boston Scientific and competitor Coloplast (OTC: CLPBY) have 10 days to submit plans for removing their mesh products from the market.

Why It’s Important

Although the surgical meshes represent only about 0.2 percent of Coloplast’s total revenue, the FDA removal of the products suggest the more than 48,000 surgical mesh patients suing Boston Scientific could have a strong case. The surgical meshes were the topic of a “60 Minutes” investigation in 2018. Johnson & Johnson (NYSE: JNJ) discontinued sales of mesh products on its own back in 2012.

“Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps,” Boston Scientific said in a statement.

In its statement, the FDA said it could no longer provide mesh patients “reasonable assurance of safety and effectiveness.”

The FDA also said women who have had surgical mesh implants and have not experienced any adverse symptoms do not need to take additional action.

What’s Next

Boston Scientific said it's disappointed with the FDA decision and plans to work closely with the FDA to understand the decision and determine a path forward.

Boston Scientific's stock traded lower by 4.2 percent at $36.22 per share Tuesday afternoon.

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Photo courtesy of Boston Scientific.

 

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