The use of vaginal mesh as implant for the treatment of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) has been well known to many physicians and adult women worldwide. It was believed as the treatment of choice for these conditions at first. However, because of the reported complications associated with vaginal mesh, the number of vaginal mesh lawsuits has risen up throughout the United States.
In 2010, there were over 100,000 procedures involving surgical mesh, and75 percent of these were implanted vaginally.
Because of the many adverse events associated with vaginal mesh surgery, the U.S. Food and Drug Administration (FDA) issued safety information about the use of vaginal mesh. The number of complaints reported to the FDA about the complications of vaginal mesh from 2008 to 2010 has reached to over 1500 cases; this is five-folds more than the recorded cases from 2005 to 2007.
The mostly reported complications related to vaginal mesh surgery include mesh erosion, development of infections, bleeding, recurrence of prolapse, pelvic organ perforation, and voiding difficulties. Out of these, the most common is mesh erosion, and has the tendency to prompt the development of other complications. A study on October 2010 was discontinued since 15 percent of its participants developed mesh erosions during the study. It was also found out that mesh erosion is the most difficult to handle, since multiple surgeries are required to correct it and most often, it is impossible to treat.
According to the FDA, vaginal mesh procedures expose patients to deadly complications. Compared to traditional non-mesh procedures, the benefits of the use of vaginal mesh is not clear. Furthermore, the agency encourages all involved surgeons to consider traditional procedures first to treat their patients with POP and SUI before resorting to vaginal mesh surgery, and only performing it when the advantages outweigh the risks.
The FDA also stressed the importance of the surgeons expertise in the placement of vaginal mesh by going through effective trainings, the careful observation of complications during the operation and recovery phase, the patients’ knowledge on the potential dangerous effects of vaginal mesh.
The number of vaginal-mesh-related complications continue to grow despite the fact that vaginal mesh FDA warning was first announced in 2008. This may be related to the continuous availability of these products in health care facilities; as there are still many manufacturers producing them making more and more physicians use their products and continue practicing vaginal mesh surgeries in hospitals or their own clinics. While it is the doctors’ responsibility to keep their patients safe, it is also important for the patients to make themselves aware about the safety and efficacy of the use of vaginal mesh.
References:
fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm
fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
femaleurologyaz.blogspot.com/2009/06/vaginal-mesh-erosion-part-2.html
In 2010, there were over 100,000 procedures involving surgical mesh, and75 percent of these were implanted vaginally.
Because of the many adverse events associated with vaginal mesh surgery, the U.S. Food and Drug Administration (FDA) issued safety information about the use of vaginal mesh. The number of complaints reported to the FDA about the complications of vaginal mesh from 2008 to 2010 has reached to over 1500 cases; this is five-folds more than the recorded cases from 2005 to 2007.
The mostly reported complications related to vaginal mesh surgery include mesh erosion, development of infections, bleeding, recurrence of prolapse, pelvic organ perforation, and voiding difficulties. Out of these, the most common is mesh erosion, and has the tendency to prompt the development of other complications. A study on October 2010 was discontinued since 15 percent of its participants developed mesh erosions during the study. It was also found out that mesh erosion is the most difficult to handle, since multiple surgeries are required to correct it and most often, it is impossible to treat.
According to the FDA, vaginal mesh procedures expose patients to deadly complications. Compared to traditional non-mesh procedures, the benefits of the use of vaginal mesh is not clear. Furthermore, the agency encourages all involved surgeons to consider traditional procedures first to treat their patients with POP and SUI before resorting to vaginal mesh surgery, and only performing it when the advantages outweigh the risks.
The FDA also stressed the importance of the surgeons expertise in the placement of vaginal mesh by going through effective trainings, the careful observation of complications during the operation and recovery phase, the patients’ knowledge on the potential dangerous effects of vaginal mesh.
The number of vaginal-mesh-related complications continue to grow despite the fact that vaginal mesh FDA warning was first announced in 2008. This may be related to the continuous availability of these products in health care facilities; as there are still many manufacturers producing them making more and more physicians use their products and continue practicing vaginal mesh surgeries in hospitals or their own clinics. While it is the doctors’ responsibility to keep their patients safe, it is also important for the patients to make themselves aware about the safety and efficacy of the use of vaginal mesh.
References:
fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm
fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
femaleurologyaz.blogspot.com/2009/06/vaginal-mesh-erosion-part-2.html