Clinical Outcomes and Reported Pain Associated with the Altis Mini-Sling Device

Dr. Greg Vigna

Altis mini-sling linked to higher rates of leg pain and dyspareunia versus traditional slings, per studies

LOS ANGELES, CA, UNITED STATES, July 16, 2025 /EINPresswire.com/ -- Dr. Greg Vigna, mid-urethral sling attorney, states, “According to their own literature, the Coloplast Altis device may cause inner leg, thigh, and hip pain when compared to traditional slings. The only Randomized Control Study regarding the Altis shows that there is at least a 2.5x risk of dyspareunia compared to full-length slings. There appears to be no justification for using this device.”

What was reported by Dr. Le Mai Tu in the “Management of female stress urinary incontinence with single-incision mini-sling (Altis): 36 month multicenter outcomes” in Neurourology Urodynamics. 2023; 42: 1722-1732? See Table 4.

Read the Altis 522 study: https://onlinelibrary.wiley.com/doi/pdf/10.1002/nau.25256

What did the SIMS Randomized Control Trial report regarding pain from the Altis?

“Our observational data also showed that Altis was associated with relatively higher rates of groin/thigh pain (18%) and dyspareunia (20%) at 15 months.

There were differences in analgesia use across groups at 36 months, but TO-TVT was least associated with use of analgesia (Altis, 8.5%; RP-TVT, 6.3%; Ajust, 4.8%; and TO-TVT, 3.4%).

However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8%.”

Read “Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT” published in Health Technology Assessment, No. 26.47: https://www.ncbi.nlm.nih.gov/books/NBK587586/

Dr. Vigna concludes, “The Atlis mesh may be too stiff and cause an increased frequency of pain when compared to traditional slings. There appears to be a significant increase in pain in both the leg and vagina, and women often require more pain medication after the Altis at 36 months when compared to full-length slings.”

Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from the mid-urethral sling, including:

1) “Other: Non-pelvic pain” including anatomic groin pain (inner leg pain), thigh pain, hip pain
2) “Pelvic/Urogenital (groin) pain”: Pain not including the inner leg, thigh, or hip, including:
a) Inability to wear tight pants
b) Clitoral pain or numbness
c) Severe pain that makes vaginal penetration impossible
d) Tailbone pain
e) Anorectal pain
f) Painful bladder
g) Pain with sitting

Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic pain syndromes caused by mini-slings such as pudendal neuralgia and obturator neuralgia. He is co-counsel with with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas, on a non-exclusive basis.

Click here for a free book on Vaginal Mesh Pain.

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Greg Vigna, MD, JD
Vigna Law Group
+1 8178099023
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