“De novo urgency was present in 37.9% of patients (implanted with the Coloplast Altis sling) by 2022…Persistence or development of urinary urgency influences the results,” states Dr. Luis Miguel Quinatana Franco, La Paz University Hospital, Madrid, Spain.
Read Dr. Franco’s article on long-term outcomes following the Altis sling in women with stress urinary incontinence or mixed urinary incontinence by clicking this link: https://link.springer.com/article/10.1007/s00192-024-05767-7
Greg Vigna, MD, JD, national mid-urethral sling attorney, states, “Dr. Franco’s study is another concerning red flag for the Coloplast Altis device that deserves attention. The Altis device in this large, long-term study appears to be associated with four-times more urgency than other mid-urethral slings. I don’t recall any devices, including the Prolift, that caused irritative bladder symptoms that high.”
What is urinary urgency? It is a sudden, compelling desire to urinate, which is often difficult to defer with or without urge incontinence.
Dr. Vigna continues, “There is evidence that urgency has a ‘far greater’ negative effect on a person’s quality of life than incontinence, frequency, or nocturia which are the other symptoms of overactive bladder. This is bad news for women who have been implanted with the Coloplast Altis device especially with the growing evidence that anticholinergic medications that are used with urgency and overactive bladder as there is an increasing body of medical literature that indicates these medications are associated with cognitive decline.”
Read “The Impact of Urinary Urgency and Frequency on Health-Related Quality of Life in Overactive Bladder: Results from a National Community Survey” to learn more (https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1524-4733.2004.74008.x) and read “Anticholinergic exposure and its association with dementia/Alzheimer’s disease and mortality in older adults” for additional information (https://link.springer.com/article/10.1186/s12877-023-04095-7).
Dr. Vigna continues, “We continue down the path to the courthouse for those injured by the Coloplast Altis device and for those who have suffered exacerbation to the injuries due to their physician’s failure to timely diagnose and treat the known complications from this device. To date we have not been successful with obtaining the internal data from the New England Journal of Medicine 2022 study that compared the Coloplast Altis single-incision sling to the Bard Ajust single-incision sling and compared the Altis to the full-length retropubic slings and full-length transobturator slings also included in the study. This study showed the single-incisions slings are associated with 2.5x the risk of dyspareunia and no meaningful reduction in chronic groin pain.”
Read the NEJM 2022 study: https://www.nejm.org/doi/full/10.1056/NEJMoa2111815
Dr. Vigna lists the RED FLAG WARNING SYMPTOMS of neurological injury or myofascial pain caused by the Coloplast Altis and Aris transobturator slings and Boston Scientific Solyx and Obtryx transobturator slings, which include:
1) Groin pain
2) Hip pain
3) Inability to wear tight pants
4) Clitoral pain or numbness
5) Severe pain that makes vaginal penetration impossible
6) Tailbone pain
7) Anorectal pain
8) Painful bladder
9) Pain with sitting
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Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by mid-urethral slings including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and complex regional pain syndrome. Ben Martin is a national pharmaceutical injury attorney in Dallas, Texas. The lawyers represent women in courts across the country.