The surgical application of a vaginal mesh and this so-called pelvic organ prolapse treatment remain the most-talked-about. Even though this controversial technique has earned intense disapproval from major groups of women, there is much to learn when it comes to its safe attachment into the non-sterile female genitalia.

The U.S. Food and Drug Administration (FDA), which was previously observed to be too loose in assessing the quality of transvaginal mesh products, is now quick in correcting its mistake of granting market approval for these questionable items. Safety announcements addressing patients, doctors, and the rest of the members of every health care team directly giving care and instructions to prolapse patients were timely released by this agency. Because of this heightened awareness by the public, national courts are inundated with filings of vaginal mesh lawsuits. Surely, women are getting a clearer view of the problem.

Pelvic organ prolapse (POP) has had a relatively greater propensity to occur in every womans life. The pelvic organs are normally exposed to pressure changes because there are just too many activities inside a womans pelvic cavity. Pregnancy and menopause are only two of the obvious reasons for this. However, according to some experts, genetic factors also play a major role in the development of this disease.

Taken from a small study conducted by a specialist at the University of Rochester in New York, it was found that prolapse may be hereditary. It was also observed that the severity of the prolapse were almost identical in the 27 pairs of women who participated in the study. This shows that a woman who has an immediate family member with grade 3 prolapse has a great possibility of developing the same stage of prolapse or more. This does not apply to all, of course. More definitive studies regarding this possibility are still ongoing.

Connective tissue abnormalities may also cause pelvic organ prolapse. These types of diseases may be shared by family members and passed to their future generations. Recognizing these forms of disorders beforehand may help women avoid pelvic floor weakening or at least minimize its development. Experts say that proper exercise and stress avoidance may work well as pelvic injury precautions.

Despite the advance of technologies, health care approaches for pelvic organ prolapse are still with damaging complications that may last a lifetime affecting women. The vaginal mesh lawsuit issues faced by lead manufacturers of health devices are enough to prove it.

References:

http://www.medscape.com/viewarticle/461719_8
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm
http://www.utilis.net/Morning%20Topics/Gynecology/Pelvic%20organ%20prolapse.pdf

There has been an update on the safety and effectiveness of using surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) which has been published by the United States Food and Drug Administration (FDA). This update is in response to the FDA receiving an significant increase to the fact that in the last 3 years, the FDA has received over 1,000 adverse event reports about mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence. These complaints range from reporting problems such as pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence. There have been several more serious complaints which involved rare but serious intraoperative injuries such as bowel, bladder, or blood vessel perforation. Many of the patients who have filed this complaints report that either medical or surgical attention was required, while others needed to be hospitalized.

The following the released statement made by the FDA in regards to the increased reports of transvaginal injuries:The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date. And although the exact cause of these adverse events hasnt been identified, theyre likely to be the result of multiple factors. Further investigation is needed.

The FDA continues by stating: The FDA continues to be concerned about this subject and will sponsor a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee. The purpose of the meeting is to discuss the safety and effectiveness of transvaginal placement of mesh for POP and stress urinary incontinence (SUI) procedures.

To date, the FDAs official stance in the matter of what is actually causing the transvaginal mesh repairs to cause injuries is that more investigation is required, while this investigation is ongoing many more patients claiming injury have begun to file transvaginal mesh lawsuits. Please consult with your doctor as soon as possible if you believe that your transvaginal mesh has caused you injury.

References:

http://www.fda-reports.com/device/transvaginal-mesh.html

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169802.htm