Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are currently affecting the lives of many women. As claimed by various researches, 30 to 50 percent of the total women population is potential victims of these ailments. The greatly affected are women who have had histories of vaginal deliveries, women who have gone through previous hysterectomies, and even post-menopausal women. Currently, the FDA has been closely studying one of the most popular procedures for these conditions due to the dramatic leap of incidences related to adverse events that occurs after the procedure. This procedure is called Trans-vaginal Mesh Implantation (TVM). This procedure is known as Trans-vaginal Mesh Implantation (TVM).
In as early as mid-1800s, medical devices known as pessaries are utilized for the treatment of POP and SUI. Originally used for contraception, it is a flexible rubber or plastic device that is shaped like a dome. Women who used pessaries found out about its advantage in impeding leakage of urine which led medical providers in the 19th century to include it in their medical practice.
Using surgical mesh to resolve disorders of the internal organs was first used in the 1950. Originally, it was used for the management of hernia. It was in 1970 that the use of mesh in surgery for the clinical management of Pelvic Organ Prolapse was first considered. Surgeries using mesh through the vagina was then brought forward in the 1990s.
For the surgical management of POP and SUI, the use of mesh trans-vaginally gained the FDA’s approval in 2002. Potential risks were not declared by surgeons before.
Lately, the surprising increment of the negative reports regarding the fatal effects of the procedure stirred up the public which prompted the FDA to examine. According to the FDA, 1500 complaints and 7 deaths were noted to have been caused by TVM based on the research done from 2008 and 2010. The agency announced that compared to what has been formally noted from 2005 to 2007, the frequency of the complaints have increased five-folds in 2008 to 2010.
Ranging from mild to severe, the most commonly recorded complaint is mesh erosion.
In the 100,000 POP mesh surgeries in 2010, 75 percent were done trans-vaginally. From the total POP surgeries of 2010, 75000 out of 100000 were trans-vaginal procedures. In 2010, 75 percent of the 100,000 performed surgical mesh procedures were TVM’s. Colporrhaphy, a non-mesh surgical management for POP, was not proven to be any less than TVM which is currently linked to increasing complaints. However, patients have believed that TVM is the modern treatment for POP.
A research in October 2010 on the safety and effectiveness of TVM was stopped because 15 percent of its subjects have developed erosions of the implanted mesh.
The TVM has possible harmful negative effects on its recipients as formally proclaimed by the FDA to medical providers and the public. Awareness of the potential harm of TVM should be made known to the public.
Whether you have experienced Implantation of TVM or is still considering the procedure,it is advisable to seek medical help and be well-informed about its potential negative effects first. Make safety a top priority for you.
References:
medscape.com/viewarticle/499503_2
obgmanagement.com/pdf/2307/2307OBG_Davila.pdf
pelviperineology.org/pelvic_floor/pdf/pelvic_floor_digest_march_2007.pdf
obgmanagement.com/pdf/2307/2307OBG_Davila.pdf
pelviperineology.org/pelvic_floor/pdf/pelvic_floor_digest_march_2007.pdf
