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Medical Device Failures — What happens if the Products Fail?

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Medical Device Failures

Surgery team operating in a surgical room

Medical devices provide numerous health benefits to our community; they made surgeries and procedures that would otherwise be impossible, a modern reality. However, some of these devices are rushed into mainstream use before they can be properly tested and are sometimes even recommended for off-label uses by doctors. Some companies are even able to bypass mandatory Food and Drug Administration (FDA) approval by arguing that its product is similar to one already on the market, leading to widespread use of a device that has not yet been properly tested.

Transvaginal Mesh

Transvaginal mesh is one such medical device that is causing severe complications for some patients. This product is typically implanted during surgery to repair damaged tissue (pelvic organ prolapse or stress urinary incontinence). However, the edges of the mesh can sometimes damage surrounding tissue, and can cause skin infection, organ damage, pain, and bladder infections.

Earlier this year, Johnson & Johnson was ordered to pay a $5.7 million jury award to a woman who suffered injuries from the company’s vaginal-mesh implant. Johnson and Johnson now faces over 36,000 lawsuits have been filed in state and federal courts over the devices, each accusing the company of improperly designing the vaginal inserts that have led to organ damage and pain.  In June 2012, the company voluntarily pulled four kinds of mesh inserts off the market after over 600 lawsuits were filed claiming the mesh was causing internal injuries.

Hip and Knee Replacements

There have also been issues with certain hip replacement devices, particularly those that have a metal-on-metal design. The metal rubbing up against metal can cause small parts to sometimes break off, leading to side effects such as elevated levels of chromium and cobalt in the bloodstream, clicking or popping near the implant, dislocation, pain and swelling, and other side effects.

Robotic Assisted Surgery

Robotic assisted surgery is becoming more and more popular to remedy certain conditions, such as pelvic prolapse, endometriosis, and others. Various computer-assisted instruments or systems can be used to assist doctors with preoperative procedures and in performing actual surgery. These devices enable surgeons to use computer technology to move surgical instruments through the patient’s body, although they cannot operate independently of the surgeon.

However, there have been reports of serious complications resulting from the use of these instruments during surgery, including organs being torn. The FDA has approved the use of these systems in operating rooms for laparoscopic surgical procedures used during cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. However, the FDA allowed one such system (the da Vinci), manufactured by Intuitive Surgical Inc.,  to be sold under premarket notification, meaning without the rigorous trials typically required of new drugs. As a result of this particular classification, the FDA cannot mandate training programs. For example, by 2002, Intuitive’s “training program” consisted of a 10-question online quiz and one day at the company’s facility.

According to a study published by The Journal for Healthcare Quality, between 2000 and 2012, thousands of complaints were reported to the FDA, including serious injuries and deaths. What’s more frightening is the discovery that many more incidents were never reported to the FDA, resulting in robotic surgery being dangerously over-promoted in terms of safety. Since then, there have been numerous patients who have experienced serious complications related to this aggressively marketed equipment.

Power Morcellators

Power morcellators are devices used to remove fibroids in the uterus during surgery. However, there have been instances of patients suffering from complications related to the device spreading cancerous cells to other parts of the body during the process, resulting in uterine sarcoma, leiomyosarcoma, and myelosarcoma. In fact, the risk became so high that the FDA issued a black-box warning on the device, indicating that it could spread and worsen undetected cancer cells.

Remedies

Some of these defects can potentially be remedied by revision surgery to remove and replace the device that is causing issues, and sometimes manufacturers like Johnson & Johnson will simply recall a product (if they face lawsuits).

For some victims, filing a lawsuit to address the pain and suffering caused by the medical device is the only remedy. Sometimes a class action is lawsuit filed on behalf of a group of people who share the same circumstances, damages and injuries, against the same defendant manufacturer. Mass tort claims are more complicated than class actions, as they cover a broad range of different claims.  The transvaginal mesh lawsuits illustrate the quintessential mass tort, as the injuries alleged range from organ damage, pain, internal injuries, to infections.

Contact Experienced Legal Counsel

If you or a loved one has suffered as a result of a medical device, the first call should be to your doctor.  Then you should seek legal counsel with an attorney experienced in defective medical device litigation.  They will be able to guide you in the right direction and advise you if compensation is available for you.

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