Early Pain with Coloplast Altis Single-incision Sling: Inner Leg, Groin, and Thigh

Table 4

Altis sling linked to unique groin pain, higher sexual dysfunction rates, and study dropouts—raising safety concerns for women

SANTA BARBARA, CA, UNITED STATES, April 22, 2025 /EINPresswire.com/ -- “The Coloplast Altis 522 study and the Coloplast Altis Investigational Device Exemption study both show the occurrence of pain in the inner leg and thigh in frequencies that are unique to this device. This device is too stiff and there are safer options," states Greg Vigna, MD, JD, national mid-urethral sling and malpractice attorney.

Dr. Greg Vigna, mid-urethral sling attorney, states, “The Altis 522 study reveals a significant risk associated with this device, as it frequently causes acute ‘anatomic groin pain’, or pain in the inner leg, thigh, or hip, from the implantation of the device. This pain is not seen with full length mid-urethral slings. When you combine this with the rate of dyspareunia, which is 2.5x that of full-length slings, no physician should be offering this device to a woman.”

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.)

What did authors say about this?

“Seven (7) subjects (3.8%) in the Altis arm experienced hip pain due to position during the procedure, with the majority of pain resolving in less than 31 days.”

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

Dr. Vigna continues, “This pain is not from positioning. This is acute pain directly caused by the device itself. To make matter worse, 23.9% of the women implanted with the Altis didn’t complete the study. These results re-affirm the bad data from the Investigation Device Exemption (IDE) study.”

What did the authors say about the IDE study in the “Two-Year Clinical Outcomes for the Altis Single Incision Sling for the Treatment of Female Stress Urinary Incontinence”?:

“The most common procedure- and device-related adverse events consisted of hip/groin pain (7.1%, 8/113), mesh extrusion (3.5%, 4/113), pelvic/urogenital pain (3.5%, 4/113), and urinary retention (1.8%, 2/113).”

Read the 2-year IDE study: https://www.ics.org/Abstracts/Publish/218/000633.pdf

Dr. Vigna adds, “How many of the women in these studies lost enjoyable sexual function? No one will ever know. We know the Altis sling has 2.5x the risk of dyspareunia compared to full-length slings. This device is too stiff and acts more like a razor in a significant percentage of women.”

How did single-incision slings compare with full-length slings in “Single-Incision Mini-Slings for Stress Urinary Incontinence in Women”?:

“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

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

“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:
1. Inability to wear tight pants
2. Clitoral pain or numbness
3. Severe pain that makes vaginal penetration impossible
4. Tailbone pain
5. Anorectal pain
6. Painful bladder
7. 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.

Click here for a free book on Vaginal Mesh Pain.

Greg Vigna, MD, JD
Vigna Law Group
+1 8178099023
email us here
Visit us on social media:
Facebook
X
LinkedIn

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.