There are times when innovations in medical technology are pushed to the public before enough is known regarding potential hazards of the technology. Despite being created with the good intention of helping others, there are instances of commercial interests override the need for safety testing. These innovations can result in suffering, which is what happened with the use of surgical mesh in treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Here is a brief history of pelvic mesh and medical malpractice suits surrounding its use.
Surgical mesh was initially used for treating hernias in the 1950s. In the 1970s, gynecologists started figuring that it might be a favorable alternative to current treatments for abdominal POP. It was in the 1990s that pelvic mesh – also known as transvaginal mesh – gained more widespread use for POP and SUI.
Women’s Health quotes Tirsit S. Asfaw, MD, director of medicine and reconstructive surgery at Weill Cornell Medical College, as saying that doctors would previously treat POP and SUI through “native tissue repair using absorbable sutures.” However, this method would fail every 3 out of 10 times and the problems would recur. Implanting a mesh to function like the connective tissue seemed to work well for hernias, and physicians considered that it could work similarly to treat these conditions.
The Food and Drug Administration approved of the use of pelvic mesh for treating SUI starting in 1996, and for treating POP beginning in 2002. They classified these products as Class II, meaning they tested its biocompatibility and mechanical performance, among other factors, but did not conduct clinical tests. Asfaw told Women’s Health that this meant “the transvaginal mesh wasn’t appropriately tested for long-term outcomes.”
Despite this, companies sold the product to hospitals and doctors by toting their known benefits: durability and consistent success. In the mid-2000s, the FDA started receiving what swiftly grew to be thousands of reports on malfunctions of the allegedly durable and “successful” mesh products. This included injuries and even deaths caused by complications from the use of these products.
Women who had pelvic mesh began reporting intense pain, erosion, bleeding, scarring, and infections. They even reported urinary issues and recurrence of the prolapse, the reasons they sought treatment in the first place. Worse, unlike the sutures used in native tissue repair, most pelvic mesh was made from materials that could not be absorbed into the body. This meant they needed to be surgically removed, which risked, and frequently resulted in, leaving pieces of mesh within the body.
The FDA now considers surgical mesh to be a Class III medical device, meaning more intensive testing must be done before a product can be released to the public. Mentor, CR Bard, and Johnson & Johnson (through a subsidiary called Ethicon) recalled and discontinued several mesh kits after the outcry. Healthcare providers are now advised to speak with people considering surgery that involves pelvic mesh about the potential hazards.
All these measures came too late for too many and companies that sold defective products have paid dearly. Boston Scientific was ordered in court to pay one woman $34.5 million in 2014, and Johnson & Johnson was forced to give $35 million to another woman in 2018. Both companies and many others have paid tens of millions after losing in lawsuit cases, and even more millions in settlements. In their race for profits, medical companies ended up paying a heavy price.
If you or a loved one suffer from medical issues related to pelvic mesh and medical malpractice, the New Jersey medical malpractice lawyers at the Law Offices of James C. Dezao, P.A. are ready to support you. For a free consultation, call today at 1-(844) 332-1527.