According to the FDA's 510(k) medical device approval process, a medical manufacturer can produce a medical device if the product is "substantially equivalent" to a product that is already on the market. In other words, the 510(k) medical device approval process does not require the manufacture to submit any evidence that the product is safe.
The FDA approved the Boston Scientific ProtoGen sling in 1996. The ProtoGen sling was a transvaginal mesh product used by doctors to treat a condition called stress urinary incontinence (SUI). SUI is a condition that occurs when the muscles supporting a woman's bladder weaken, leading to urine leakage and other problems.
Contact us if you suffered any of these TVM side effects:
- Continual Pain
- Organ Perforation
- Pain During Sex
- Recurring SUI
After the FDA approved the ProtoGen device, other manufacturers produced transvaginal mesh slings of their own. These manufacturers included Influence Inc., Gynecare, and Ethicon, a Johnson & Johnson company.
During the first three years that ProtoGen was on the market, Boston Scientific received 500 complaints from women suffering adverse side effects. By the time ProtoGen was recalled in 1999, Boston Scientific distributed 23,000 devices. Ethicon, Gynecare, TVT, and other transvaginal mesh manufacturers followed suit, saying that they would stop selling certain products.
What do all of these products have in common? They met FDA 510(k) medical device standards based on a recalled medical device.
Between 2005 and 2010, nearly 4,000 women notified the FDA of "adverse events" connected to transvaginal mesh products. Today, women continue to suffer medical complications associated with defective TVM. Some women needed surgical removal of the product, while others sustained continuous pain and other problems.
Since 2011, TVM device sales have plummeted by 70%, and in 2012, the FDA issued more than 500 orders for post-market observation of transvaginal mesh products.
If you or someone you love suffered the devastating side effects connected to transvaginal mesh implants, you need a personal injury lawyer today. At the Daspit Law Firm, we are committed to helping people like you get the financial compensation that they deserve. Contact us now at (713) 364-0915 for a free evaluation of your case.