Vaginal Mesh Safety

01.09.2012

Vaginal Mesh Recalls

According to the American College of Obstetricians and Gynecologists (ACOG), the use of a vaginal mesh implant in treatment of pelvic organ prolapse (POP) has gained popularity, especially in 2004.

 

Four years ago, the Food and Drug Administration (FDA) announced that they have received more than one thousand complaints regarding to vaginal mesh complications. In 2011, the number of reports nearly reached four thousand. It is because of these complaints that the FDA followed up their previous Safety and Communication Update. It was stated in this Safety and Communication update that the benefits of undergoing a vaginal mesh implant, in comparison with traditional methods, may not be as superior due to the risks associated with a vaginal mesh. Examples of the most common risks may include mesh erosion, pelvic organ perforation, bleeding, infections, pelvic pains and painful copulation. Bowel perforation, urinary incontinence and vaginal shrinking are also some other risks that may occur after a vaginal mesh implant procedure.

 

According to medical specialists, a minimally-invasive insertion of the mesh into the vagina is required.  Once the mesh is inside, it will then be anchored within the area that the prolapse has occurred. The trocar or the ‘wings’ of the mesh will then be placed onto higher places within the pelvic area to help raise the mesh and support the pelvic organs. Once everything is in place, the trocar will then be sutured into the pelvic tissues to provide a permanent and stronger support. During post-operation, a patient may seem to be able to carry on with her life yet unknowingly, complications may be arising. With the possibility of the mesh shrinking over time, the prolapsed organs may not have a permanent and durable support for long. This may be one of the probable causes of a recurrent prolapse.

 

It has been recommended by the FDA for doctors and surgeons to fully equip their patients with knowledge regarding a vaginal mesh implant surgery. The FDA has also advised patients to learn about the other methods of treatment before fully considering a vaginal mesh implant surgery.

 

The efficacy of a vaginal mesh implant regarding treatment to pelvic organ prolapse, stress urinary incontinence and abdominal hernia has been disclosed before. Yet, the potential risks that may be associated with this type of surgical procedure must be made visible to public. Hence, educate yourself on the possible complications that might arise after a vaginal mesh implant surgery before considering this as your primary treatment option.Start this education by reading a Vaginal Mesh Complications Blog.

 

References:

 

acog.org/Resources_And_Publications/Committee_Opinions/Committee_on_Gynecologic_Practice/Vaginal_Placement_of_Synthetic_Mesh_for_Pelvic_Organ_Prolapse

fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079028.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=vaginal%20mesh&utm_content=10

 

fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

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