Coloplast Altis Injury Lawsuit Filed: Extremity Pain in Focus

Study reveals unique post-operative pain; Vigna Law Group investigates malpractice and safety concerns

SANTA BARBARA, CA, UNITED STATES, September 12, 2024 /EINPresswire.com/ -- “Our client has allegedly been seriously injured from the Altis mini-sling. The data from the Coloplast Altis 522 study reveals acute pain in the limb following the procedure that, in this study, was unique to the Altis group and not in the full-length mid-urethral sling group," states Greg Vigna, MD, JD, national mid-urethral sling and malpractice attorney.

Dr. Greg Vigna, mid-urethral sling attorney says, “We have added Coloplast to a currently filed medical malpractice claim. The data as to the safety of this device is in question and you simply need to look at the Altis 522 Study to see a big problem.” (Case number: 2024L008002, filed in Cook County, Illinois, County Department, Law Division)

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?

“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, “My firm’s opinion as to the cause for the post-operative pain is the Altis device. The positioning of a patient is the same for the comparator, which was a full-length transobutaror or retropubic sling, and the comparator was zero. The positioning of the women during a mid-urethral sling placement is the same.”

Dr. Vigna, concludes, “Obviously, we are waiting for the long-term internal data from the 2022 New England Journal of Medicine because this study has data that compared the Altis to another mini-sling and compared to full-length retropubic slings and transobturator slings at three years.”

Read 2022, NEJM article: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815

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

Case number: 2024L008002
Filed In: Cook County, Illinois, County Department, Law Division

Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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