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Transvaginal Mesh Removal May Not Help Victims

Study Finds that Removing Transvaginal Mesh Does Not Help Damage to Organs

transvaginal meshA new study, conducted for a meeting regarding the problematic side effects of transvaginal mesh implants, shows that removing the pelvic devices may not improve symptoms of transvaginal mesh injury, including pain and incontinence.

In April, the Food and Drug Administration (FDA), announced that it will create new guidelines for transvaginal mesh devices, after receiving complaints from thousands of women all over the country for years. Originally, the devices were approved through an expedited approval process called the 510(k) rule, which allowed medical devices that were significantly similar to a previously-approved medical device to obtain faster approval. The original transvaginal mesh device was recalled due to severe injury in 2001.

The April announcement, also stated that the FDA has reclassified transvaginal mesh devices as “high risk,” and nothing similar will receive expedited approval. The companies that manufacture the pelvic mesh devices will have to comply with stricter safety testing as well.

The findings will be reported during the American Urological Association’s annual meeting.

“In the worst-case scenario, you have a recurrence of the [pelvic organ prolapse symptoms] and the patient still has the pain” attributed to the device, said Dr. Philippe Zimmern, a urologist at the University of Texas Southwestern Medical Center in Dallas, who worked on one of the new studies.

The study followed 123 women after they had surgery to remove transvaginal mesh devices. Fortunately, most of the women – about 67% – became pain-free after surgery. Also, patients’ reported pain levels were much lower two to three years after surgery.

However, pain had been the primary issue for all of the women before the surgery to remove their transvaginal mesh implants.

Another similar study, this time from the University of California, Los Angeles, found much less positive results. Of the 214 women surveyed up to three years after their surgery, which they opted for due to a range of issues including severe pain, the women continued to suffer similar problems. Two-thirds of the women reported that they had only mild symptoms or no pain at all, but the rest had moderate to severe pain. Half of those with continuing symptoms reported pain during sex, and 28% reported urine leakage at least once per day.

“In the worst-case scenario, you have a recurrence of the [pelvic organ prolapse symptoms] and the patient still has the pain” attributed to the device, said Dr. Philippe Zimmern, a urologist at the University of Texas Southwestern Medical Center in Dallas, who worked on one of the new studies.

The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Cases

Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.

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