Aesculap Denies Wrongdoing, Defends Its Device
In a Monday statement, Aesculap said concerns surrounding its VEGA System were “largely addressed” through prior product liability litigation resulting in more than half the cases being dismissed. The company insists it did not knowingly cause false claims and settled solely to avoid protracted litigation.
The VEGA System was never recalled, Aesculap emphasized, noting it has been used successfully in “thousands of patients” since its 2010 launch. The company said implant loosening can stem from numerous factors, including surgical technique, and that it updated guidance and training in 2018–2019 for proper cementing procedures.
Former Employee Sentenced in FDA Forgery Scheme
The DOJ added that its agreement with Aesculap also resolves issues involving two devices sold without FDA clearance — a result of a former employee forging approval documents. That employee pled guilty last year and received one year in prison plus a year of supervised release.
Aesculap said no patient injuries were linked to those devices and that it recalled them, reimbursed customers, and later obtained proper FDA authorization.
