“The study aims to compare the efficacy and safety of bulking agents and single-incision slings … at our follow-up there was no discernible difference in terms of effectiveness or quality of life between patients treated with bulking agents and those treated with single-incision slings (Coloplast’s Altis sling)” … Dr. Lorenzo Campanella, Rome, Italy.
What else did Dr. Campanella’s study , “Ultraminimally Invasive Surgery in Stress Urinary Incontinence Treatment: Prospective Comparative Analysis between Bulking Agent and Single Incision Sling” in Preprints.org explain?
“Of the 159 patients suffering from stress urinary incontinence, 64 were treated with bulking agents and 75 with a single incision sling.
Compared to the ones treated with a single-incision sling, the patients treated with bulking agents showed less and mild postoperative complications.
Groin pain: 0% in the Bulkamid Group, 10.8% in the Altis Group (9 out of 75 patients)
Dyspareunia: 0% in the Bulkamid Group; 2.5% in the Altis Group (2 out of 75 patients)
De novo urgency: 0% in the Bulkamid Group; 6.6 % in the Altis Group (5/75 patients)”
To read Dr. Campanella’s study: https://www.preprints.org/manuscript/202402.0019/v1
Dr. Greg Vigna, “The Altis sling should have a red flag attached to it. Women are not being warned that the FDA still does not support the safety and efficacy of mini slings which includes the Coloplast Altis device. This study, along with others including the big New England Journal of Medicine Study, shows that mini-slings didn’t reduce groin pain when compared to full-length mid-urethral slings and had 2.5x the risk of resulting in dyspareunia or painful sex.”
New England Journal of Medicine: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815
Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from mid-urethral slings include:
1) Groin pain
2) Hip pain
3) Inability to wear tight pants
4) Clitoral pain or numbness
5) Severe pain that makes vaginal penetration impossible
6) Tailbone pain
7) Anorectal pain
8) Painful bladder
9) Pain with sitting
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic pain syndromes caused by mini-slings that include the Boston Scientific Solyx and Coloplast Altis sling that includes 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: https://vignalawgroup.com/publications/
Resources:
https://medtech.pharmaintelligence.informa.com/MT030541/FDA-Panel-Calls-For-More-Studies-Of-Mini-Slings-For-Urinary-Incontinence
https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh
