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Friday, May 29, 2015
If you’ve experienced uncommon, debilitating symptoms after a surgery involving a medical implant, you may be the victim of a defective medical device. Examples of medical devices that can be defective include knee or hip replacements, forms of birth control, and bone grafts.
All surgical devices must be approved by the Food and Drug Administration before introduction to the public. However, a government program called (510)K provides a quicker route to legalizing a surgical product. If this product is proven substantially equivalent to an existing one, it is authorized to forego any further clinical testing. Companies can choose this path of least resistance, subsequently causing patients painful, life-changing experiences. In the rush to market and sell these products, companies have faced multi-million dollar lawsuits.
The most common surgical device to seek approval through the (510)K program is knee and hip implants. Slipping through clinical trial cracks, failures of poorly designed implants have led to complications including:
Healthy replacement procedures are generally meant to last up to fifteen years. However, patients with these particular complications have needed revision surgery within five years.
From 2005 to 2010, close to 4,000 women claimed to have experienced complications due to transvaginal mesh. This synthetic product is implanted through the vagina to correct Pelvic Organ Prolapse and Stress Urinary Incontinence. Mesh erosion and vaginal extrusion are two painful complications that can cause:
Released in 2000, the Mirena IUD is a long-term birth control device implanted in the uterus. Since its introduction, 4,500 claims of adverse reactions to the Mirena IUD have been reported. Failures have caused cases of organ perforation. Symptoms include back and breast pain, as well as acne and weight gain. In 2009, the FDA warned Mirena’s manufacturer Bayer to re-evaluate marketing claims of pain-free post-surgical results and risks. Despite lawsuits, Bayer continues to offer the Mirena IUD.
NuvaRing entered the market in 2001. Another form of birth control, this flexible ring is inserted into the vagina monthly. Though effective, its primary safety issue is risk of blood clotting. In 2011, the FDA reported a comparison study demonstrating a much higher risk of venous thrombosis (deadly blood clots in the veins) in NuvaRing users. Over 100,000 consumers have participated in a petition for a refined safety label through a non-profit safety awareness group called Public Citizen. Manufacturers Organon and Merck have faced lawsuits from over 1,000 women.
The infuse bone graft is a synthetic protein used to alleviate spinal pain. FDA approved in 2002, it is a leading choice for spinal surgery devices available today – yet controversy surrounds this product. Researchers were allegedly paid by manufacturer Medtronic to withhold disclosure of side effects. Side effects include:
Many lawsuits have been filed against Medtronic, while the FDA have issued warnings to health care providers regarding debilitating and fatal risks.
If you are suffering from a faulty implant or medical device, we understand how debilitating and painful this can be. The personal injury attorneys at Malman Law understand what you are going through. We can help you obtain the compensation you deserve. Contact us today for a free consultation about your case.
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2 years ago I was involved in a trucking accident involving a 14-wheeler truck that nearly disabled me for life. Steve fought to make sure that I received the most possible compensation for my injuries. I was about to take the insurance company’s lowball offer, but decided to call Steve first – it was the best decision I’ve made yet
NOAH TAFFELPersonal Injury Victim