Today, FDA sent warning letters to 2 breast implant makers as part of ongoing efforts to protect patients: Allergan did not comply w/ post-approval study requirements; Ideal Implant Inc. cited for failures w/ quality system & medical device reporting regs. https://go.usa.gov/xvMbA   pic.twitter.com/p60gRc5GdP

Today, FDA sent warning letters to 2 breast implant makers as part of ongoing efforts to protect patients: Allergan did not comply w/ post-approval study requirements; Ideal Implant Inc. cited for failures w/ quality system & medical device reporting regs. https://go.usa.gov/xvMbA  pic.twitter.com/p60gRc5GdP
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news