December 3, 2019 More than 80,000 deaths in the past decade were linked to complications from medical devices, according to a recent New York Times article. This shocking statistic has resulted from manufacturers concerning themselves more with the benefits of introducing new medical equipment quickly, rather than thoroughly testing for safety. Once the products were released, device makers failed to sufficiently monitor the soundness of new medical devices and neglected to alert doctors and patients to potential risks, resulting in life-altering injuries.
Unfortunately, the regulatory agency that should have stopped this, the Food and Drug Administration (FDA), enabled medical equipment makers to avoid backlash from negative outcomes by granting manufacturers special exemptions for certain products. For example, the FDA allowed makers of surgical staplers and other devices to file reports of malfunctions in a concealed database. Therefore, only the FDA knows the exact number of complications arising from certain medical equipment. The problem with reporting incidents in this type of hidden database is that the doctors and scientists who are dedicated to improving medical device safety do not have vital information on the outcomes of these products. But, victims of one medical device – transvaginal mesh implants – are now pushing back.
80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices
The New York Times reports that medical device companies spent about $8 billion resolving transvaginal mesh lawsuits over the last decade. These mesh lawsuits help confirm that medical equipment is frequently cleared for sale with little to no screening or clinical data.
According to investigative research by the International Consortium of Investigative Journalists (ICIJ), injuries can occur from a variety of medical devices like surgical mesh (used in transvaginal mesh and hernia mesh products) eroding inappropriately into delicate tissue, birth control implants that cause autoimmune disorders, metal hips that fail or release poisonous debris, and staplers that misfire. The high number of injuries and complications are a result of uncertain regulatory approvals and a lack of observation once the products are released.
Transvaginal mesh lawsuits have become so prevalent because medical device regulations are relaxed, allowing companies to introduce new products to market without testing them. Companies must only prove that the device is similar to one that was previously approved, even if that product is outdated or subsequently pulled from the market.
However, there are solutions available to avert these thousands of injuries. Medical and professional organizations like the FDA can initiate improvements on the current system by making reasonable changes, like tightening approval standards, fixing post-market surveillance, and restricting the medical device industry’s influence.
Medical Device Complications and Mesh Lawsuits
As technology continues to improve, new innovations are introduced that are designed to help heal and support our bodies. Still, the medical devices that enter the market do not always function as intended. The use of mesh implants is often encouraged to treat hernias, incontinence, and prolapse. Manufacturers typically make surgical mesh out of synthetic materials. The mesh is used to make medical devices such as hernia mesh and transvaginal mesh. The function of the products is to provide additional support to weak or damaged muscle tissue. Safe, functional alternatives to synthetic mesh include tissue from animals or the patient. The dangers posed by synthetic mesh products include inflammatory foreign body reaction and erosion that can make removal of the mesh impossible. Other complications from mesh surgeries and implantations include:
- Persistent Pain including pain during intercourse
- Infection
- Hernia, prolapse, or incontinence recurrence
- Scar-like tissue that sticks tissues together (adhesion)
- Blockage of the large or small intestine (obstruction)
- Bleeding
- Abnormal connection between organs, vessels, or intestines (fistula)
- Fluid build-up at the surgical site (seroma)
- A hole in neighboring tissues or organs (perforation)
- Migration and mesh shrinkage (contraction)
How We Help Medical Device Victims
Seek justice with the help of our experienced attorneys. Our Dallas, Texas, medical device law firm has battled corporate giants on behalf of individuals like you for 20 years, aggressively fighting to hold companies responsible for dangerous products. If you or a loved one suffered catastrophic injury or death caused by unsafe medical devices, we can help.
