Altis Single-incison Sling: Groin Pain, Dyspareunia, and Coital Incontinence

NEJM study reveals that mini-sling devices, like the Altis, show 2.5x higher dyspareunia risk and more pain than other slings

SANTA BARBARA, CA, UNITED STATES, March 26, 2025 /EINPresswire.com/ -- “The underlying data from the New England Journal of Medicine, published on March 31, 2022, that revealed a 2.5x dyspareunia risk in the mini-sling group has been published. The results show more pain at all time points for the Altis compared to other slings,” states Dr. Greg Vigna, national pharmaceutical injury attorney.

Read the New England Journal of Medicine (NEJM), “Single-Incision Mini-Slings for Stress Urinary Incontinence in Women”: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815

Dr. Vigna adds, “The mini-sling group in the NEJM’s study is widely cited and reveals that mini-slings cause dyspareunia 2.5x more than full-length mid-urethral slings and do not reduce groin pain.”

The New England Journal of Medicine on March 31, 2022:

“A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group… At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings… Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group.”

Read the Single-Incision Mini-Slings for Stress Urinary Incontinence in Women. The New England Journal of Medicine. March 31, 2022: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815

Dr. Vigna says, “The internal data for the NEJM was published and the Altis device has over twice the dyspareunia as other slings at 15-months and more incontinence during intercourse at all time points.”

What did the SIMS RCT report regarding DYSPAREUNIA (pg. 51)? See Table 17: Summary of AEs, by procedure (continued) 2.

What did the SIMS RCT report regarding COITAL INCONTINENCE (pg. 52)? Table 17: Summary of AEs, by procedure (continued) 1.

Read the SIMS trial (Health Technology Assessment, No. 26.47): https://www.ncbi.nlm.nih.gov/books/NBK587586/

Dr. Vigna concludes, “The Altis mesh is too stiff, and no woman would consent to this device had they been provided frequency of risks compared with other surgical options.”

Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from the mid-urethral for physician negligence and/or product claim against the manufacturers of the device include:

“Other: Non-pelvic pain” including anatomic groin pain (inner leg pain), thigh pain, hip pain.
“Pelvic/Urogenital (groin) pain”: Pain not including the inner leg, thigh, or hip including:
- 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 mini-slings such as Coloplast Altis sling and Boston Scientific Solyx 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.

Greg Vigna, MD, JD
Vigna Law Group
+1 8178099023
email us here
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