Back in August of 2007, Johnson & Johnson was instructed to stop making, marketing and selling its DePuy hip. The production halt was the result of thousands of claims of defective hips.
More recently, the company has been prohibited from selling its transvaginal mesh under its Gynecare Prolift line. After all of the complaints, federal officials looked a little further into these products and found nearly 20 potential deficiencies. Never mind that J&J had previously continued to market and sell the defective medical product without FDA approval.
These transvaginal mesh implants are used to help to treat Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP) and Pelvic Floor Repair. The mesh is surgically implanted or attached to the vaginal wall. Unfortunately, the mesh has been proven to expose users to a number of serious and life-threatening conditions.
Our Queens medical malpractice attorneys understand that there are a number of vaginal mesh manufacturers that have received clearance from the Food and Drug Administration (FDA). Unfortunately, the approval wasn’t based on their effectiveness in treating vaginal problems. Instead, these devices were only approved based on their prior history of use in other parts of the body, like when they’re used to repair hernias. These products were never properly tested on their ability to be used for transvaginal procedures. Since at least 1999, there have been complaints reported from these mesh implants. During that year, there was a voluntary recall issued by Boston Scientific to recall about 20,000 transvaginal mesh implants. Still, the FDA continued to approve the same implants from different companies.
Since then, there have been thousands of cases involving these defective products, including both the hip replacements and transvaginal mesh from Johnson & Johnson.
Johnson and Johnson started selling their Gynecare Prolift back in 2005 before they even applied for consent from the FDA. It wasn’t until 2008 when the product was approved. From 2005 to 2010, there were close to 5,000 reports of injury or death because of these products.
The side effects of the complications that these devices can cause can be debilitating. These effects include pelvic pain, organ damage, bowel perforation, urinary problems and severe infection.
Since these reports, the company has acknowledged their high failure rates. Recent reports indicate that more than 10 percent of patients who had these devices had to have “revision surgery” to fix the problems. Many believe that the number will actually be much higher than this as more and more users experience defects.
All too often, officials with the FDA allow device makers to launch products for consumers before they’ve been properly tested and before their long-term effects are known.
They’re oftentimes allowed to get by because the manufacturer contends that the new products are “substantially similar” to existing products that have already been approved. Many times, the only “testing” that these products ever get are clinical trials in Third World countries where professional oversight from federal regulators isn’t available. And, unfortunately, the government oftentimes fails to conduct any kind of independent study to ensure consumer safety. Instead, government officals rely on these “studies” which are conducted by the manufacturer of the device.
When consumers are harmed, sound legal advice is critical.
The Law Offices of Nicholas Rose, PLLC offers free consultations to accident victims. Call 1-877-313-7673 to speak with someone about your case and to discuss your rights today!