Dr. Greg Vigna, national mid-urethral sling attorney states, “The author must have had some concerns regarding the stiffness of the Altis device and some perceived belief that it rolls or buckles after implantation. These devices are intended to lay flat.” What did the sheep study show?: “The structurally stiffer Altis sling had decreased tissue integration [...]

“The Altis mid-urethral sling was a bad device during the IDE study and there is nothing reassuring about the safety of this device in the FDA ordered Altis 522 study. The SIMS trial revealed that the Altis sling had more pain at all time points compared with full-length mid-urethral slings. The authors of the SIMS [...]

“Furthermore, a comparison of court documents and the public record indicates that adverse events and patient deaths were misreported to FDA reviewers and were inaccurately reported in both the published literature and on the device label, providing patients and clinicians with inaccurate information about the device’s safety,” states Harlan M. Kruholz, MD. What else did [...]