How Defective Medical Devices Slip Past the FDA

Friday, May 29, 2015

How Defective Medical Devices Slip Past the FDA

Written by Malman Law, reviewed by Steve J. Malman.

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.

Knee and Hip Replacements

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:

• Bone fractures and dislocation
• Tissue damage
• Metal toxicity affecting the heart, thyroid and circulatory system
• Cyst formation
• Adverse Local Tissue Reaction (ALTR)

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.

Transvaginal Mesh

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:

• Organ perforation
• Urinary complication
• Infection
• Scarring

The Mirena IUD

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

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.

Infuse Bone Graft

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:

• Severe back pain
• Difficulty breathing
• Leg pain
• Male sterility
• Bone and nerve injury
• Increased risk of cancer

Many lawsuits have been filed against Medtronic, while the FDA have issued warnings to health care providers regarding debilitating and fatal risks.

Contact Malman Law – Personal Injury Attorneys

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.