If you’re thinking about having transvaginal mesh (TVM) surgery, you may be wondering if it’s the best way to manage stress urinary incontinence (SUI) or pelvic organ prolapse (POP). Or perhaps you’ve have a TVM implant that’s causing you pain and you’re wondering if you should have it removed. In either situation, it’s important to know that TVM removal surgery is extremely complicated and much of the time, taking out the device in its entirety isn’t always possible.

How TVM is Implanted in the Vagina

POP occurs when the vaginal muscles are weakened and the organs start to migrate into the vagina. SUI is when weakened muscles in the pelvic floor or a weak sphincter muscle allows urine to leak from the bladder. Pelvic mesh is a woven plastic material that usually has an oval center to act as a sling to support the organs and straps that are attached/sutured to the vaginal wall to keep the sling in place.

Why Surgery Isn’t Always an Option

Since TVM is just an implant, can’t you just remove it if complications arise? Unfortunately, it’s just not that easy. Many studies have reported the complications that are caused due to TVM.

• In 2008, the FDA publishes its first safety communication stating that transvaginal mesh has a high occurrence of adverse effects.
• “[Removal] of vaginal mesh is akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and power lines below. It is difficult if not impossible to remove all the mesh and do it safely,” explained Bay Area pelvic surgeon Michael Thomas Margolis to the FDA advisory panel in September 2011.
• A study in 2013 followed 58 women who required mesh removal surgery. 17 (29%) required an additional surgery to remove the residual mesh, 13 once and 4 twice. The researchers concluded that, “patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.”
• In 2016, the FDA changed vaginal mesh from being a class II device (moderate risk) to a class III (high risk).
• “Because transvaginal mesh is considered a permanent implant, surgery to remove the mesh can be difficult and may increase a woman’s risk of additional complications or symptoms,” explains UCLA Health. “Over time, the tissue grows into and around the mesh, so removing the mesh without damaging the surrounding tissue and organs is a delicate process.”

Transvaginal mesh is a complicated surgery that is difficult to undo due to the tissue that grows in and around the medical device. While many doctors are able to insert this mesh, few have the training or skill to remove it. Additionally, those who can perform these surgeries may not be able to fully remove the mesh or they’ll need to perform multiple surgeries. Even with mesh removal surgery, many times the damage caused by the mesh is irreversible. For example, a study conducted by UCLA found that 28% of women who had mesh removed said that they had urine leakage at least once a day and half had pain during sex.

If you’ve have complications from transvaginal mesh, contact us today. You were given a faulty medical device and weren’t told of the potential complications that now impact your everyday life. Our compassionate team would love to talk with you so see if we can help you to receive financial compensation.

##Sources

“Transvaginal Mesh Kits—How “Serious” Are the Complications and Are They Reversible?” Science Direct. Accessed April 19, 2018. https://www.sciencedirect.com/science/article/pii/S009042951201076X

“Get the facts about transvaginal mesh complications”. Mayo Clinic. Accessed April 19, 2018. https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300?pg=2

“Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh”. WBUR. Accessed April 19, 2018. http://commonhealth.legacy.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh

“FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks.” FDA. Accessed April 24, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm

“Transvaginal Mesh Removal”. UCLA Health. Accessed April 24, 2018. http://obgyn.ucla.edu/mesh-related-complications

“Removal of Faulty Mesh for Incontinence”. WebMD. Accessed April 24, 2018.https://www.webmd.com/urinary-incontinence-oab/news/20140519/removal-of-faulty-mesh-for-incontinence-may-not-improve-womens-symptoms#1

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