Coloplast Altis Single-incision Sling: Increased Inner Leg, Groin, Thigh Pain, and Dyspareunia

Table 4: Device and/or procedure-related adverse events through 36 months

Altis mini-sling linked to higher rates of leg pain and dyspareunia—evidence shows it's riskier than full-length slings and may cause serious injury

SANTA BARBARA, CA, UNITED STATES, June 10, 2025 /EINPresswire.com/ -- “The Coloplast Altis 522 Study shows the occurrence of inner leg and thigh pain in frequencies that are unique to this device. This combined with more than 2x the risk of dyspareunia makes this device an unacceptable option for women,” states Greg Vigna, MD, JD, national mid-urethral sling, malpractice attorney.

Dr. Greg Vigna, mid-urethral sling attorney, “The Altis 522 Study describes inner leg, thigh, or hip pain following implantation of the Altis at rates not observed with full-length mid-urethral slings. Given these risks, along with the 2.5x risk of dyspareunia compared to full-length slinds, no physician should consider 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

How did single-incision slings, including the Altis sling, compare with full-length slings in “Single-Incision Mini-Slings for Stress Urinary Incontinence in Women” published in the New England Journal of Medicine (2022)?:

“Dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group.”

Read the NEJM article that compared single-incision slings to full-length slings: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815

Dr. Vigna concludes, “We represent women who have experienced complications after being implanted with the Coloplast Altis device, including inner leg, thigh, and hip pain, dyspareunia, and pudendal and/or obturator neuralgia. The Altis mesh is too stiff and does not belong in the pelvic areas of women.”

Read the sheep study study comparing the stiff Altis to the less stiff Solyx in sheep:
https://pubmed.ncbi.nlm.nih.gov/32707267/&source=gmail&ust=1714408542754000&usg=AOvVaw0BCt_bz4PI36jAIiz2ow2S

Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from the Coloplast Altis 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 the Coloplast 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 and the physicians who implant them.

Click here for a free book on Vaginal Mesh Pain.

Greg Vigna, MD, JD
Vigna Law Group
+1 817-809-9023
email us here
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