Transvaginal mesh litigators at Babbitt & Johnson, P.A. start the first transvaginal mesh sling case against medical device company, Boston Scientific on August 11th, 2014.
Transvaginal mesh manufacturers are able to obtain Food and Drug Administration (FDA) approval through the less-stringent approval process known as 510(k). This process does not require manufacturers to conduct clinical trials as long as the product is “substantially equivalent” to a product already on the market.
Boston Scientific faces hundreds lawsuits from victims who suffered injuries after surgery to correct pelvic organ prolapse (POP) or stress urinary incontinence (SUI) issues.
After six years and hundreds of lawsuits, the FDA has finally considered reclassifying transvaginal mesh for pelvic organ prolapse (POP) repair as a “high-risk device.”
When medical devices or implants fail, the negligence of the manufacturer needs to be addressed. At Babbitt & Johnson, P.A., we hold manufacturers responsible for promoting unsafe devices and make certain that clients receive just compensation for their injuries. If you have injuries associated with transvaginal mesh implants, contact our transvaginal mesh attorneys to determine if you are eligible for compensation for your injuries.