As technology and research becomes more advanced, breakthroughs in the medical industry are revolutionizing health care. New developments are made every day to improve the quality of life for those suffering health conditions. Additionally, new developments are making life easier and more convenient for those who are in good health.
While millions of people benefit from medical advancements, many are harmed. Devices like hip and knee implants seek to restore mobility to injured patients. However, medical devices made by Stryker and DePuy Orthopaedics cause serious side effects for some patients. Many require additional surgery to correct the problems caused by these defective implants.
Women encounter a unique set of medical devices that were created to improve the quality of life. Transvaginal mesh was developed for women who suffer pelvic organ prolapse. Unfortunately, this device can cause serious side effects, such as uterine perforation.
New birth control technology has also been introduced. NuvaRing and Mirena are extremely effective at preventing pregnancy. However, these medical devices can cause deadly side effects. NuvaRing causes increased risk of heart attacks, stroke, and blood clots. Mirena users report perforation of the uterus and migration of the device into other parts of the abdomen.
Dangers of 510(k) FDA Approval
A number of medical devices received expedited FDA approval through the 510(k) Premarket Notification process. Typically, the FDA requires clinical trials to be conducted before a drug or medical device receives approval to be released to the public. However, through the 510(k) process, clinical trials are not required. The FDA will approve a drug or device if the manufacturer can prove a significant similarity to another drug or device that has already been approved.
Through the 510(k) process, a number of medical devices were released onto the market with no trials or extended testing. This proved disastrous when several defective devices caused unexpected side effects. Data was collected on high-risk medical devices that received 510(k) approval between 2005 and 2009. The data shows that more than 70 percent of these devices were later recalled due to safety concerns and reported side effects.
Types of Defective Medical Devices
Hip and Knee Implants
Hip implant systems from DePuy and Stryker have faced thousands of lawsuits over device failure and serious side effects that require patients to undergo additional surgeries to correct the faulty devices. Metal-on-metal components in the devices caused corrosion. This led to metallic debris that was released into the soft tissue and bloodstream of many patients. As a result, many suffered metallosis, or metal poisoning. The knee implant systems from Zimmer encounter similar issues that require revision surgery for a large number of patients.
The Infuse Bone Graft is a system developed to encourage natural bone formation in patients with spinal problems. Many Infuse patients suffered severe side effects such as paralysis and death from off-label uses of the system. The manufacturer Medtronic Inc. is accused of paying millions for illegal marketing practices.
Used to treat pelvic organ prolapse, a transvaginal mesh is a surgical mesh device that is implanted into the vagina to support the vaginal wall. These implants can perforate and erode a woman’s reproductive organs. Transvaginal mesh can also cause pain, incontinence, pain during intercourse, and infections of the reproductive system. Additional surgeries are often required to correct problems caused by transvaginal mesh.
Birth Control Devices
NuvaRing is the first and only birth control ring on the market. While clinical trials have shown NuvaRing to be extremely effective, many patients suffered blood clots, stroke, and heart attacks. Mirena is a small, T-shaped plastic device that is implanted into a patient’s uterus for up to 5 years. Mirena also shows high success at pregnancy prevention. However, the device can perforate the uterus and migrate to other areas inside the body. Many Mirena patients have required surgery to locate and remove the device from the fallopian tubes, cervix, bladder, and abdominal cavity.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.