Transvaginal mesh (TVM) was recently described by the publication, The Independent, as, “insufficiently tested and poorly regulated plastic mesh devices… shown to erode and disintegrate, slicing through organs and vaginal walls to cause paralysis, chronic pain, sepsis, loss of sex life and even organ failure.” If this medical device is so dangerous, why in the world is it still on the market in the United States?
A History of Warnings Concerning TVM
After extensive research, the FDA published in July 2011 a report with the conclusion that, “The FDA has identified serious safety and effectiveness concerns over the use of surgical mesh.” So many people reported complications to the FDA, they basically had to report that it is a dangerous product!
Then, in January 2016, the FDA published the following statement: “FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury.” TVM went from a Class II to Class III device because of the high risk it posed!
Here is an important fact to consider from Dr. Tom Margolis, a prominent pelvic surgeon in the San Francisco Bay Area: Prior to 1996, synthetic material for slings was rarely used and those who used synthetics stopped due in large part to the high complication rate. In 2001, within 5 years of the synthetic polypropylene tension-free vaginal tape’s introduction (Johnson & Johnson TVT), the American Medical Association added surgical procedure code 57287 (removal or revision of sling for stress incontinence) to the (Current Procedural Terminology) CPT codebook. Then, in 2006, CPT code 57295 (removal of mesh) was added. Between 1907 and 1996, there was no need for a surgical codes to remove slings. Shortly after the TVT was introduced, a tidal wave of complications mandated that these two new Billings codes for removal of these systems be implemented. TVM is so defective that they have their own removal codes!
Why Is TVM Still Used in the US?
So with the FDA and other studies showing the risks of TVM, why is it still used in the U.S.? Consider this: Approximately 300,000 surgeries for pelvic organ prolapse (POP) are performed each year and at least one-third of all prolapse operations involve some type of mesh. Additionally, it’s estimated that 50 percent of women over the age of 40 eventually experience symptoms of urinary incontinence (SUI) or POP. With so many women struggling with these embarrassing conditions and getting surgeries to address this issue, it’s a multi-million dollar industry.
TVM was introduced to the market as the “gold standard” to quickly fix these health conditions and was a much faster and easier surgery to perform than traditional natural tissue repair. But while TVM seemed like a good option, the risks have many times outweighed the benefits. Additionally, with the FDA warnings, new medical codes needed, and tens of thousands of lawsuits involving TVM, it seems obvious that this dangerous device should be taken off of the market.
Due to the immense number of women speaking out against TVM, New Zealand and Australia have banned the use of TVM and the UK and Ireland have halted its use. It’s time for the U.S. to follow the example of these other nations and stop future TVM surgeries. It’s time to put people above profits… the health of millions of women depend on it.
“As vaginal mesh procedures are suspended, why did it take so long for women’s pain to be taken seriously?” The Independent. Accessed July 13, 2018. https://www.independent.co.uk/voices/vaginal-mesh-scandal-procedures-suspending-women-pain-doctors-a8440616.html
“Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”. Federal Register. Accessed July 13, 2018. https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/default.htm
“THIS PAINFUL VAGINAL IMPLANT MAY BE BANNED IN BRITAIN. IS THE U.S. NEXT?”. Newsweek. Accessed July 13, 2018. http://www.newsweek.com/painful-vaginal-implant-may-be-banned-britain-us-next-722939
“Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse”. FDA. Accessed July 17, 2018. https://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf
“Thousands of women left in agony after ‘gold standard’ surgery”. NY Post. Accessed July 25, 2018. https://nypost.com/2017/05/25/thousands-of-women-left-in-agony-after-gold-standard-surgery/