Transvaginal mesh (TVM) was banned in Australia and sales were stopped on January 4, 2018 because the Therapeutic Goods Administration (TGA) which regulates Australia’s medical devices, deemed that, “the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.” So if TVM is banned in Australia, why is it still being used in the U.S.?
TVM is made out of polypropylene and looks somewhat like a woven screen that you would find on your window. It’s used in women who have stress urinary incontinence (SUI) which is when the bladder is weakened due to childbirth or age and leaks urine. TVM is also used to help women who have pelvic organ prolapse (POP) which is when organs drop below the vagina causing a bulge. TVM acts as a sling or a hammock to help support the bladder or other organs. Unfortunately, many problems such as mesh erosion, migration, organ perforation and chronic pain have been associated with this medical device. Australian Senator Hinch even said in a speech before Parliament that Australian women were used as “guinea pigs” and that after the “experimental surgery” they felt that they were “dying a very slow and agonising death”. The use of vaginal mesh was “one of the greatest … abuses of mothers in Australia’s history.”
In 2017, there were 700 claims made in Australia that were consolidated into a class action lawsuit against Johnson & Johnson who is the parent company of Ethicon which makes TVM implants. In the U.S., there are currently over 100,000 TVM mesh lawsuits, the largest number ever against Johnson & Johnson, and yet Australia has banned this medical device and the U.S. has not.
In fact, many lawsuits in the U.S. have been settled in favor of the plaintiffs. For example, C.R. Bard was the first TVM company to lose a case and had to award the plaintiff $3.6 million. In May 2015, Boston Scientific was ordered to pay $100 million to Deborah Barba of Delaware for compensatory and punitive damages. In April 2017, a Philadelphia Common Pleas Court awarded $20 million to a woman who had a Johnson & Johnson TVM device who suffered from chronic pain and had to have multiple corrective surgeries.
In December 2017, New Zealand was the first major country to ban vaginal mesh. Ministry of Health spokesman, Stewart Jessamine, stated, “We’ve reviewed that data and come to the opinion that the data is sound and we now believe the risks of the use of these products in the pelvis for prolapse and stress incontinence far outweighs the benefits.”
In Scotland, the use of mesh was suspended in 2014 and in 2015, Health Secretary Shona Robison apologized to women who were left in severe pain due to TVM and confirmed that the suspension would remain in place.
If you’ve had a faulty TVM implant and have suffered from mesh erosion, migration, chronic pain and had to have corrective surgery, please contact us today. You may be able to receive financial compensation. Moreover, you’ll be uniting with thousands of other women who have suffered due to TVM and this may help to take this dangerous product off the market.