The utility of the Coloplast Altis sling and Boston Scientific Solyx is questionable at best.
Dr. Greg Vigna, “The utility of the Coloplast Altis sling and Boston Scientific Solyx is questionable at best. The FDA still does not support their safety or efficacy despite the FDA’s Obstetrics and Gynecology Device panel recommending more studies of mini-slings for stress urinary incontinence in 2011. Their utility has been called to question by reliable physicians including Dr. Cheryl B. Iglesia from the Georgetown University of Medicine.”
“The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active…Groin or thigh pain did not differ at 36 months (when mini-slings were compared to full-length mid-urethral slings)” …Cheryl B. Iglesia, MD
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner states, “Dr. Iglesia has predicted the future previously when she questioned the utility of vaginal mesh devices used for pelvic organ prolapse devices back in 2010.”
“Conclusion: At 3-months, there is a high vaginal mesh erosion rate with no difference in overall objective and subjective cure rates. The study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs” …Chreryl B. Iglesia, MD
Dr. Vigna adds, “Unfortunately it took the FDA nine more brutal years to finally ban polypropylene vaginal mesh devices for prolapse in 2019 when they agreed with Dr. Iglesia’s findings in 2010 because Coloplast and Boston Scientific could. not convince the FDA that their devices had a favorable benefit-risk profile. In other words, the dangers of vaginal mesh devices used for pelvic organ prolapse outweighed the benefit and added no value over non-mesh repair.”
Dr. Vigna concludes, “The time is right for combination product liability and medical malpractice cases across the country in State Courts. Women are not being warned that the FDA STILL does not support the safety and efficacy of mini-slings which include the Coloplast Altis and Boston Scientific Solyx. The FDA called for more studies on mini-slings back in 2011. Now we have a reliable study that was published in the New England Journal of Medicine that has gained the attention of Dr. Iglesia who speaks her mind. She has concerns for the women who may be risking their sexual function when other options are available. What woman would consent to a 2.5x risk of dyspareunia with a mini-sling when compared with full-length mid-urethral slings when there is no reduction of the risk of groin pain.”
Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from mid-urethral slings include:
- Groin pain
- Hip pain
- Inability to wear tight pants
- Clitoral pain or numbness
- Severe pain that makes vaginal penetration impossible
- Tailbone pain
- Anorectal pain
- Painful bladder
- Pain with sitting
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic pain syndromes caused by the Solyx and Altis sling including pudendal neuralgia and obturator neuralgia. He represents women with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas. The attorneys are product liability and medical malpractice attorneys, and they represent neurological injuries across the country.
Click here for a FREE BOOK on Vaginal Mesh Pain.
For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/ and visit this link for information regarding sling related complications.
Resources:
https://medtech.pharmaintelligence.informa.com/MT030541/FDA-Panel-Calls-For-More-
Studies-Of-Mini-Slings-For-Urinary-Incontinence
https://www.nejm.org/doi/full/10.1056/NEJMoa2111815?af=R&rss=currentIssue
https://cdn.mdedge.com/files/s3fs-public/issues/articles/obgm0340813_evidence_iglesia.pdf
https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-
urogynecologic-surgical-mesh
https://web.archive.org/web/20170812114041id_/http://www.bapelvicsurgery.com/images/Vagin
al_Mesh_for_Prolapse__A_Randomized_Controlled.9%20copy.pdf
Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
email us here
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