Vigna Law Group Position Statement: The FDA Was Duped About the Risks of Midurethral Slings
Despite the arrival of mid-urethral slings on the US market in 1998, the FDA was fueled by misleading studies designed to miss long-term complications.
—Greg Vigna, MD, JD
SANTA BARBARA, CA, USA, Nov. 9, 2022 /EINPresswire.com/ — “Despite mid-urethral slings entering the US market in 1998, the FDA received misleading studies designed to miss complications term which entail vaginal, inguinal and abdominal dissection to remove the injury causing the plastic mesh. Well, the risks of long-term complications are there and they are bad for women in the United States and around the world. All we can do is sue the manufacturers and doctors who implant them. This is what we do”…Greg Vigna, MD, JD, National Pharmaceutical Injury Attorney
April 16, 2019 FDA: Surgical Mesh Considerations for SUI
1) “Mesh sling erosion through the vagina is the most commonly reported mesh-specific complication in SUI mesh surgeries”
2) “The safety and effectiveness of mini-slings for female SUI have not been sufficiently demonstrated. Currently, it is unknown how mini-slings compare to multi-incision slings with respect to safety and effectiveness for the treatment of SUI”
3) The safety and effectiveness of multi-incision slings are well established in clinical trials that have followed patients for up to one year.
4) The long-term complications of surgical repair of mesh slings for SUI that are reported in the literature are consistent with adverse events reported to the FDA.
5) Longer follow-up data is available in the literature, but there are fewer such long-term studies compared to studies with one-year follow-up.
At age 15, the most common indications for surgery to remove the mesh are painful complications, ORGAN EROSION, EROSION OF THE URETHRA, FISTULAS and other serious complications other than EROSION IN THE VAGINA or URINARY RETENTION. (Female Pelvic Medicine and Reconstructive Surgery, Volume 28, Number 4, April 2022)
14.9% of women have groin or thigh pain after standard mid-urethral slings at three years, with 4.6% requiring any type of analgesic (New England Journal of Medicine, 386; 13, 31 March 2022)
14.1% of women have groin or thigh pain after single-incision mini-slings at three years, with 7.6% requiring any type of pain medication (New England Journal of Medicine, 386; 13, March 31, 2022)
Mini-strips Dyspareunia was reported in 11.7% in the mini-strips group versus 4.8% in the mid-urethral strips group. (New England Journal of Medicine, 386; March 13, 31, 2022)
Position of Vigna Law Group: the FDA was duped about the rate of complications
-No rates are mentioned in the FDA statement beyond one year due to the complete lack of reliable studies provided by the manufacturers, as their studies were Mickey Mouse at best.
– Ongoing registries for newly implanted women are necessary for women’s safety due to the continued failure of defense manufacturers to provide reasonable post-market surveillance of their products and reasonable clinical testing of their products. Mickey Mouse’s studies of the past are complete.
– Women must be assessed in writing at 7.9% risk at 15 years of requiring surgical removal of all or part of the mesh because of complications at this risk rate is increasing; half of these surgeries take place after two years; multiple surgeries may be needed to manage complications; and the results include disabling pain and substantial impairment of sexual function which are not uncommon.
Greg Vigna, MD, JD concludes, “All we can do is sue the manufacturers of these devices and the doctors who implant these devices. Simply picking these devices off the shelf is malpractice. There is a lot of data in the Multidistrict Litigation complaint files and it is time these files were opened for review. Manufacturers had reason to know the frequency, severity, and latency of complications requiring surgical removal of these devices in women who did not know. Manufacturers have failed to provide adequate warning to women around the world for monetary gain. Doctors are on the hook and there is a lot of data in the public domain.
Symptoms of neurological damage caused by midurethral slings include:
1) Groin pain
2) Hip pain
3) Inability to wear tight pants
4) Clitoral pain or numbness
5) Intense pain that makes vaginal penetration impossible
6) Tailbone pain
7) Anorectal pain
8) Painful bladder
9) Pain while sitting
Dr. Vigna is a California and Washington DC attorney who focuses on catastrophic injuries and neurological injuries caused by transvaginal mesh devices, including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and regional pain syndrome complex. Ben Martin and Laura Baughman are national pharmaceutical damages attorneys in Dallas, Texas.
To learn more about the anatomical basis of TOT complications, including obturator and pudendal neuralgia and treatments for obturator and pudendal neuralgia, click here.
Read our FREE BOOK on vaginal pain.
For articles, video resources, and information, visit the Pudendal Neuralgia Education Portal or visit https://tvm.lifecare123.com/.
Click on the following link for information on sling complications: https://tvm.lifecare123.com/slingebook.html
Greg Vigna, MD, JD
Vigna Law Group
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