In October 2008, the Food and Drug Administration (FDA) released their first safety notification regarding the use of a transvaginal mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). As stated in this notification, the bureau has received more than 1,000 complaints regarding the use of a vaginal mesh. However, despite the number of complaints, the FDA concluded that the complications arising from the use of a vaginal mesh were rare.


In July 2011, the FDA was able to release their second update on the safety and effectiveness of a vaginal mesh during POP and SUI surgeries. According to the second report showing a significant increase of complaints as compared to the first report, the complications associated with a vaginal mesh surgery were not rare. From the 2,874 complaints filed to the regulatory board of the FDA, 1,503 complaints were related to a pelvic organ prolapse repair whilst 1,371 complaints were in relation to a stress urinary incontinence procedure. It is because of this significant increase in numbers that the FDA has released a safety guide on the proper use of a vaginal mesh during surgery.


A vaginal mesh is made from synthetic materials, which are most often non-absorbable, materials. It may come in different sizes or shapes and they are likely to have ‘wings’. These wings, better known by doctors as trocar, are the junctures which will holds the mesh in place once it has been anchored into the vaginal area. Since POP and SUI conditions are often caused by the lowering of the pelvic organs into the vagina, the mesh will act as a suspension, holding the organs up in their proper places.


Complications that are most usually associated with a vaginal mesh implant differ per disorder. In a pelvic organ prolapse, the most common complications are vaginal erosion, pelvic pains, bladder perforation, blood vessel perforation and pain during copulation or dyspareunia. In a SUI mesh implant, complications such as bleeding, infections and recurrent incontinence issues may prevail.


The FDA has stated that multiple complications might arise during post-operation. With the number of complaints that the FDA has been receiving and with the number of patients out there seeking vaginal mesh lawsuit compensation, the regulatory board highly recommends doctors and health care workers to fully-inform their patients about the potential complications and risks involved in a transvaginal mesh implant.
 

REFERENCES:
 
fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
 
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

Used by many doctors for the surgical management of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), vaginal mesh surgery is very well known worldwide.  These two conditions generally affect adult women all over the world, most specifically those who have a history of menopause, hysterectomy, or vaginal delivery.  

A woman’s pelvic organs such as the urethra, bladder, rectum, and uterus are supported by the vaginal wall which is reinforced by connective tissues. When these connective tissues weaken, pelvic organs are displaced; this condition is called Pelvic Organ Prolapse. As a result of this, pelvic muscles weaken and lead to SUI.   SUI is characterized by the uncontrollable leakage of urine from the bladder which is often caused by involuntary actions like sneezing and coughing; this also occurs during physical exertions like heavy-lifting. 

Many doctors are still doing vaginal mesh surgery to their patients despite the information given by the U.S. Food and Drug Administration (FDA) about its efficacy and safety.  The agency pointed out that this medical device can lead to seriously debilitating side effects.   In fact, thousands upon thousands of cases of negative events were reported to the FDA. 

There are many complications linked to the use of vaginal mesh, and the most common ones are mesh erosion, bleeding, infection, pelvic organ perforations, recurrence of prolapse, and pain.

Mesh erosion is the most usual complication; it is also known as mesh exposure, protrusion, or extrusion. This happens when the incision line does not recover well, displacing the mesh out of the vagina.  The first symptom for this condition is the sensation of pulling or tightness inside the vagina. This can also prompt further complications like infection, bleeding, appearance of vaginal discharges, and pain. 

When the fit of the vaginal mesh implanted does not conform to the vaginal wall, pain may be felt by the patient.  Almost always, prolonged sitting or standing can trigger pain. In the same way, sexual intercourse can also bring about pain. This condition is known as dyspareunia.

Bleeding and pelvic organ perforations are most likely to occur while the physician is performing the procedure. This can result from the improper handling of medical instruments. 

The development of infections occurs after the operation if the surgical wounds recover poorly.  Factors that can lead to slow healing of the incision include inadequate nutrition and overexertion.  Infections related to the implantation of vaginal mesh poses great danger, so careful monitoring during the recovery period is very important. 

Recurrence of prolapse is very possible since most vaginal mesh products do not ensure permanent treatment. These deadly complications caused the rising number of lawsuits filed against mesh manufacturers on all sides of the United States recently. 

A series of corrective procedures may be required to repair these vaginal mesh side effects; in some cases, they can be impossible to be repaired, and have even caused a few deaths.  With these alarming reports, the FDA issued an announcement to all medical providers to consider non-mesh procedures first before deciding on vaginal mesh surgery.