“Single-incision slings are associated with more pain at 4 weeks, more dyspareunia, and require more frequent further surgeries than full-length mid-urethral slings. No class of women would derive benefit from this device when compared with traditional full-length slings,” states Greg Vigna, MD, JD.

What was the author’s conclusion of the SIMS trial published in the Health Technology Assessment Volume 26, Issue 47, December 2022?

“More women in the SIMS group reported dyspareunia and/or underwent further surgery.”

What did the SIMS trial report regarding pain at 4 weeks? (see Figure 13)

Read the SIMS Trial: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9761550/

What did the Coloplast Altis 522 Study show? (see Table 4)

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

Dr. Greg Vigna, mid-urethral sling attorney, states, “Given the results from the SIMS trial from England, which provided Level 1 Evidence that the Altis is associated with more pain and a 2.5x increased risk of dyspareunia compared with full-length slings and the findings from the Coloplast Altis 522 study which reveals leg pain when compared with full-length slings, it is my law firms position that this device is defective and that there is no class of women who will derive benefit from this device compared with full-length mid-urethral slings.”

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, and 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 the Coloplast Altis sling and Boston Scientific Solyx sling that include 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.

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