By Jennifer Stanich-Banmiller, Founder
Periscope News Group
May 30, 2018
On May 26, 2018, Wael Agur, advisor to the Scottish Government’s mesh safety review board, recommended that transvaginal mesh (TVM) devices made after 2012 which contain Chinese sourced resin should be withdrawn immediately. This mesh, which was sourced by Boston Scientific, has been known to shrink inside the body up to 50% and can erode within months.
TVM is no stranger to criticism and has been under scrutiny for years. There are many critical defects that are linked to TVM and have caused tens of thousands of women to be inflicted with permanent disabilities. Not only have the original components and designs been deemed unsafe, but now there is suspicion that counterfeit plastics have entered the market increasing the dangerous risks to patients.
In order to fully understand the controversy surround TVM, we must first start at the beginning of the FDA approval for this faulty medical device. It was originally intended to fix hernias and it was then approved for use in the vagina to help with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh would be attached to the muscle walls and act as a sling to support the organs. Unfortunately, TVM was never tested in one vagina before it was put into thousands of patients.
Polypropylene is one major design flaw in TVM. “I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body. It’s well known that its oxidatively unstable,” states plastics engineer and mesh lawsuit witness Duane Priddy.
The problem with polypropylene is that it can erode in the body. When the slick outer coating is dissolved and absorbed into the body, the mesh can break apart creating sharp edges. These pieces can migrate in the body and slice tissue, nerves, and organs causing pain, bleeding, infection, and potential amputations. Furthermore, tissue can grow around these shards making the mesh virtually impossible to remove.
Currently, the problem has intensified with a new report that was brought to light by 60 Minutes. Boston Scientific was no longer able to receive their supply of polypropylene from Marlex by Chevron Philips in 2005 and therefore had to find a supplier that could provide the same materials as approved by the FDA. It was said that a source in China, Emai, had “tons of Marlex imported from Chevron Phillips in Texas.” When Boston Scientific analyzed the packaging, it was reportedly fraudulent and when they tested the plastic, only two of the 11 parameters were the same. To further prove their case, 60 Minutes purchased 15 mesh kits and analyzed them at a plastics lab confirming that all of the products matched the supposedly inauthentic Chinese plastic. Nevertheless, Boston Scientific ordered a 30 years supply (and also denies that any of the 60 Minutes report is “false and irresponsible”.)
Even before the story of potentially fraudulent Chinese plastics came to light, New Zealand was the first country to fully ban TVM followed by Australia in 2017. It’s speculated that the UK may be next to fall in line. While Scotland is currently only considering banning TVM with Chinese plastics, this issue is certainly bringing up the dangerous risks associated with this medical device and the integrity of the companies that are responsible for making them.