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“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 [...]
“TephaFex sling is completely removed by the body over two years. This would eliminate more than half of all mesh revision surgeries at 15-years,” states Greg Vigna, MD, JD, national mid-urethral sling attorney. What is the long-term risk of surgery for polypropylene mesh related complications? “In our study population, the 15-year risk of sling revision [...]
“When patients report lower limb or groin pain immediately after surgery, injury to the obturator or pudendal nerve is often suspected, and mesh removal most often cures the pain. When isolated pain occurs later on after mid-urethral sling insertion, the first-line treatment is often medical," states Camille Armengaud, MD. Read Dr. Armengaud’s article “Serious complications [...]
“I doubt a study comparing the Altis to the TephaFex mid-urethral sling will ever happen. I anticipate the P4HB technology will finally end the polypropylene vaginal mesh debacle,” states Greg Vigna, MD, JD, national mid-urethral sling attorney. What was reported about P4HB slings in the 2024 article, “Safety and Efficacy Report for the Poly-4-Hydroxybutyrate as [...]
“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 [...]
“Polypropylene and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%) … A higher incidence of long-term pain events were observed in the polypropylene group,” states Dr. Jordi Sabadell. What did a randomized polypropylene tranobturator sling versus PVDF transobturator sling show in Dr. Jordi Sabadell’s article “Polypropylene and polyvinylidene fluoride transobturator slings [...]
“Clearly, the women who were assigned into the Coloplast Altis group ‘drew the short straw’ as their sexual function was placed at risk as a result of this device when compared with full-length mid-urethral slings” states Greg Vigna, MD, JD, national mid-urethral sling attorney. Dr. Greg Vigna, national mid-urethral sling attorney, states, “Level 1 Evidence from [...]
“One prospective cohort study of 116 women receiving Altis reported groin/hip/thigh pain (8%), dyspareunia (1%), and tape exposure (3.5%) at 12 months’ follow-up, but, interestingly, no further new AEs at 24 months’ follow-up," according to Health Technology Assessment, No. 26.47. Dr. Greg Vigna, national mid-urethral sling attorney states, “It's an Interesting point about the Altis [...]
“Despite Boston Scientific admitting to ‘serious injury’ caused by their Marlex mesh, doctors continue to fail to timely diagnose and treat the known complications caused by these devices," states Greg Vigna, MD, JD. Dr. Greg Vigna, national pharmaceutical injury attorney, practicing physician, and expert in Life Care Planning, comments, “Despite PVDF, a safer alternative material, being [...]
“Single-incision slings are associated with more pain at 4 weeks, more dyspareunia, and require more frequent further surgeries than full-length mid-urethral slings. No class of women would derive benefit from this device when compared with traditional full-length slings," states Greg Vigna, MD, JD. What was the author’s conclusion of the SIMS trial published in the [...]
