“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)” states Dr. Lorenzo Campanella, Rome, Italy.

What else did Dr. Campanella’s study, “Ultraminimally Invasive Surgery in Stress Urinary Incontinence Treatment: Prospective Comparative Analysis between Comparative Analysis between Bulking Agent and Single Incision Sling” in Preprints.org?

“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 states “Dr. Campanella’s study showed the Altis mini-sling caused 10.8% of women to suffer groin pain. The Altis sling and the Bard Adjust mini-slings, when considered together performed poorly in the 2022 New England Journal of Medicine (NEJM) Study, which showed that mini-slings didn’t reduce groin pain when compared to full-length mid-urethral slings and had a 2.5x risk of dyspareunia or painful sex when compared to full-length mid-urethral slings.”

Read the NEJM 2022 Study: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815

Dr. Vigna concludes, “The FDA to date does not support the safety or efficacy of mini-slings. The two studies (above) show more than 10% of women had groin pain after surgery. We believe this device is defective and shouldn’t be selected by their implanting doctor. We represent women with serious pain syndromes following implantation of the Altis device.”

Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from the Altis sling including:
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