In 1998, Dr. Aaron Kirkemo was working in Ethicon’s Medical Affairs Department. Although he acknowledged that mesh devices posed serious health risks, he defended the decision not to include them in the medical literature. Kirkemo’s decision to omit these risks from medical literature may have been a contributing factor in the lawsuit. But his statements did not convince the FDA to approve the device.
Violation of anti-competitive laws
The FDA recently reclassified the transvaginal mesh used to treat pelvic organ prolapse as a Class III medical device, requiring premarket approval. This premarket approval process applies to Class III medical devices because they lack sufficient evidence of safety to meet the FDA’s standards for a new medical device. The deadline for manufacturers to file premarket approval applications was July 5, 2018. As a result, those companies that did not submit a PMA were forced to remove their products from the market.
The FDA ordered mesh manufacturers to stop selling transvaginal mesh in the U.S. following a review of their premarket application submissions. The agency concluded that manufacturers had failed to provide adequate long-term safety assessment, and had failed to establish a clear benefit over native tissue repair. The agency concluded that there was no evidence that the risks of transvaginal mesh outweighed the benefits.
False advertising
A recent article in Bloomberg Businessweek looked at the FDA’s 510(k) clearance process for vaginal mesh, a procedure that had previously been reviewed by the Institute of Medicine. According to the article, many vaginal meshes were cleared for sale based on their similarity to other products. But is that evidence enough for a recall or ban? The FDA does not have the power to revoke a product’s approval based on false claims – they’re just limited to re-examination and recalls.
In addition to false advertising, the FDA also found that the manufacturers of vaginal mesh failed to submit sufficient information regarding the safety of their products. This violated the FD&C Act, 21 U.S.C. 360e(b). Although FDA approved the ProteGen sling in 2010, it was not studied or tested by clinical trials to assess its safety and effectiveness.
Anatomical distortion of the vaginal cavity
The FDA approved the first mesh surgical device, the Elevate, in 2000. The mesh was not associated with any systemic or autoimmune diseases. This results in long postmarket history. But is the FDA data reliable? Is it possible to draw conclusions based on these findings? A recent study looked at these questions and other issues. Here are some key findings. This study suggests that mesh surgical devices are not harmful, but there is no evidence that they are without risk.
Anatomical distortion of the vaginal chamber is one of the most common chronic conditions among women. Although the pathogenesis of these disorders remains unclear, there is a growing need for surgical intervention. Moreover, 30 to 10% of the patients undergo a second surgery for incontinence or reconstructive surgery. In this situation, bioprosthetics and synthetic mesh prostheses have been developed to improve surgical outcomes. This review aims to explore the use of mesh in vaginal surgery.
Loss of services claim
A significant number of claims filed against Boston Scientific have been brought under the umbrella of “loss of services” and are based on the FDA’s approval of the device. There are more than 23,000 claims filed against the company for these products, with the West Virginia state court judge deciding that he would not dismiss the claims. Massachusetts state court judges have assigned approximately 1,700 cases to a single judge.
If you believe that a transvaginal mesh implant has caused your injury, you should file a lawsuit immediately. Failure to file a claim within the required timeframe may result in a denial of your claim. Furthermore, if the mesh is implanted incorrectly or has a defect, it can be considered medical malpractice. Loss of services claims are not straightforward, but they can help you recover damages for your pain and suffering. By contacting an attorney at McDonald Worley, you will get a free consultation and learn if you have grounds to pursue a claim.
Settlements
In the past five years, there have been multiple settlements for victims of transvaginal mesh. A jury has awarded victims millions of dollars, while a judge has ruled that the manufacturers are responsible for the majority of these claims. The judge has urged the companies to settle the cases and cut their losses, but manufacturers have declined to do so. According to Bloomberg, Johnson & Johnson boasts a $121.3 billion net worth and spent $57 million a day on advertising through Dec. 31. A lawsuit involving the company is also the largest collaborative national litigation.
More than 800 patients in the pelvic mesh FDA approval lawsuit received offers of $100,000 or more. However, about half of them received offers of $13,000 or less. Many of these lawsuits also include plaintiffs’ claims that the manufacturer hid the risks, and improperly implanted transvaginal mesh constituted medical malpractice. Settlements for these cases have been reported in several U.S. states, including California and Washington.
Trials
Thousands of women have sued J&J and Ethicon for deceptive marketing of vaginal mesh devices, claiming that the companies misrepresented the safety of their products and failed to warn women of the risk of serious complications. The lawsuits claim that the companies deceptively marketed their products with claims like “FDA approved” or “FDA cleared,” which implies that the products have undergone extensive regulatory scrutiny. The state of California and other jurisdictions are involved in the original investigation, and attorneys general may bring similar claims against these companies as well.
The FDA has also warned about the risks associated with pelvic mesh. In 2008, the agency issued a Public Health Notification and Additional Patient Information regarding surgical mesh. In 2011, the agency released a safety communication about the use of pelvic mesh for preventing postpartum depression and other conditions. The FDA warned that the mesh was not without risk, but noted that serious complications could arise if it is used in the wrong ways. In July 2012, C.R. Bard recalled its Avaulta Plus vaginal mesh after receiving over a thousand lawsuits and almost 80 deaths.