Pelvic organ prolapse is a troubling condition that causes the pelvic organs to slip out of place and typically requires corrective surgery that has, in recent years, included the application of transvaginal surgical mesh. This plastic mesh product is designed to hold the pelvic wall together and add strength while the body repairs itself. However, studies indicate that approximately 10 percent of the 75,000 women who have received the mesh implants have experienced erosion or exposure of the mesh, requiring follow-up surgery.
The FDA Steps In
We have frequently explored the emerging risks associated with the product and the hundreds of federal lawsuits involving manufacturers of surgical mesh. In that post, we mentioned that the FDA had ordered more than 30 individual surgical mesh manufacturers to study the rates of organ damage and other side effects linked to the product.
It would appear that Johnson & Johnson’s Ethicon unit, one of the country’s top manufacturers of the dangerous surgical mesh, is hoping to sidestep the mandated three-year study period imposed by the FDA earlier this year by discontinuing four individual surgical mesh products.
What is interesting about the company’s decision to discontinue the products is its claims to the reasoning behind it.
“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy,” the company said in a statement.
Evidence of Dangers Surface
The fact that the FDA has documented that at least 10 percent of surgical mesh recipients require follow-up surgery to remove the product within twelve months of the initial surgery makes Johnson & Johnson’s claim questionable at best.
“These companies know they will never be able to prove safety and efficacy of these devices in the studies mandated by the FDA in Januray of this year,” says Lana Keeton, a recipient who has endured 17 individual surgeries to remove the mesh since it was implanted in 2001. She is also actively involved with the Truth in Medicine group, which has lobbied the FDA on the risks of surgical mesh.
Initially, the product was viewed as an innovative improvement to traditional surgery, which experts say can also come with complications. The fast-tracked approval of the surgical mesh products came from the FDA likely due to the fact that other mesh products had already become popularized in various types of surgical procedures.
But the internal complications that arose following the release of the products from Johnson & Johnson, among five other companies, led the FDA to issue the call for further studies. In a recent statement by the company, they indicated that they expect the FDA to withdraw that ruling after the products have been completely discontinued.
What’s especially troubling, especially for those who underwent the dangerous surgical procedure, is that the FDA has determined that the mesh product offers no added value over the traditional surgery that requires stitches.
What do you think about Johnson & Johnson’s discontinuation of the surgical mesh products and their approach to denying the allegations that the products are unsafe? Share your thoughts and experiences with us in the comment box below.
Surgical Mesh Attorneys in Washington
If you have experienced any form of health complications as a result of a transvaginal mesh procedure, you may be entitled to compensation for your injuries. Contact the personal injury attorneys at Davis Law Group to schedule a free, no-obligation consultation today by calling 206-727-4000.