Most people are in the dark about how the FDA works and how drugs and medical devices are approved to be used by the public. We put so much trust and blind faith in this government agency with every pill that we take or with every surgery that we believe will solve our medical ailments. However, it’s scary to learn that there are definite loopholes in the FDA’s regulatory system that have allowed big pharmaceutical companies to profit at the expense of innocent patients. Here’s what you need to know.
Approximately one third of women will have issues with the weakening of their pelvic muscles due to childbirth or age. This means that they may have difficulty controlling their bladder or that their organs such as the uterus or intestines can collapse into the vagina. This clearly can cause embarrassment, complications and difficulties for the women who are suffering from these conditions. This is where transvaginal mesh (TVM) comes in. The mesh is made out of a plastic that’s called polypropylene and is used as a sling that supports the organs to prevent them from sagging into the vagina.
Unfortunately, there are many problems with polypropylene in the vagina:
Polypropylene mesh wasn’t originally designed for this use. In the 1960s, it was created to help reinforce the muscle walls in the abdomen for hernia sufferers. With a hernia, the intestines push through and tear the muscle wall. The mesh creates a barrier so that the intestines stay in place. Well, since the FDA approved mesh for that use, medical device companies were able to use a loophole in the FDA’s regulatory procedures called the 501k process. The FDA manages medical products using a class system that rates whether they are low, moderate, or high risk. Mesh was deemed as Class II which translates to moderate risk. As such, the medical device companies weren’t required to perform expensive clinical studies as long as the manufacturer could prove “substantial equivalence” to an already approved device. What does this mean? TVM was put on the market and inserted into hundreds of thousands of women without it ever being tested in a single vagina to determine the risk factors. This led to 61 devices being approved for market based on only two devices that were approved in 1985 and 1996.
If you have had TVM surgery, contact Periscope Group today. The FDA and the manufacturers of TVM need to be held accountable for seeing women as lab rats and for not performing the proper testing to ensure that this product was safe. We may be able to help you receive financial compensation for the difficulties this faulty medical device caused in your ability to live a happy, healthy, and normal life.
