Hernia Mesh Recall | 合法醫療器材資訊網

2018年11月27日—Herniameshmanufacturershaverecalledmorethan211000unitsfrom2005to2019.Complicationsincludemeshfailure,puncturedorgans ...

The FDA classified most of the hernia mesh[1] recalls from 2005 to February 2019 as Class 2. A Class 2 recall means a person may suffer temporary or medically reversible adverse health consequences from the recalled product.

One recall for C.R. Bard’s Kugel Patch[2] was a Class 1. This means the recalled product could cause serious adverse health consequences or death.

Three companies were the source of the majority of recalls: Johnson & Johnson’s Ethicon[3] unit (which issued a market withdrawal, not a recall), C.R. Bard[4] and Atrium[5].

Companies that issued hernia mesh recalls did so voluntarily because they discovered a problem. The FDA rarely forces a manufacturer to recall a product. Manufacturers of recalled mesh include Atrium Medical, Bard Davol,...