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The safety of medical products, devices, and medications is federally regulated by the U.S. Food and Drug Administration (FDA). When notified of a product’s potential defectiveness, contamination, or potentially harmful health concerns, the agency may take action to compel the manufacturer to issue a product recall to ensure public safety. According to the FDA, the » Read More

More than 100,000 hernia repair surgeries are performed annually in the United States. Four out of five procedures require the use of hernia mesh, a medical device that supports and strengthens tissue surrounding the hernia as it heals. Surgery is successful for most patients. For others, the implanted hernia mesh fails and causes serious health » Read More

Used frequently in laparoscopic uterine fibroid removal and other hysterectomy procedures, a power morcellator is a surgical instrument used in minimally-invasive surgeries. The use of a power morcellator offers less loss of blood and a quicker recovery time for many patients. However, the U.S. Food and Drug Administration (FDA) warned against the use of power » Read More

Thanks to ongoing advances in technology, health care providers are able to utilize a wide range of medical devices to diagnose conditions earlier, provide improved patient monitoring, develop a targeted treatment plan, and communicate regularly. Unfortunately, while all medical devices must go through a series of clinical trials before they are approved by the FDA, » Read More

Hip replacements are common for elderly people but are also something some younger people must deal with if they are seriously injured. Getting a new hip, regardless of your age, can make you move better and enjoy your life again without excruciating pain. However, sometimes hip replacements do not achieve their goal. You may feel » Read More

When you go see your doctor, whether it is for a minor issue or for major surgery, you never expect to be worse after you leave. Unfortunately, that is exactly what happens to some people who deal with defective medical products. The health consequences of a medical device not working as intended can be deadly. » Read More

It is of the utmost importance that you take care of your heart. A healthy heart is the key to a long, healthy life. However, some people need a little assistance in ensuring that their heart is functioning correctly. Having a heart pump surgically implanted is one way to get medical assistance. For some, that » Read More

When you have a medical device implanted or replaced, you expect it to help you have a better quality of life. Whether the device is used to treat a medical condition or reduce your pain level, having it can help you feel better and enjoy life, but things do not always go as planned. Exactech » Read More

While patients who must use medical devices might believe that the companies who manufacture them do so according to rigorous standards, this may not always be the case. Many organizations claim that the Food and Drug Administration (FDA) does not test devices as thoroughly as they should, allowing them to come into the market. Although » Read More

In February of this year, surgeons across the country received a draft of a recall letter from Exactech that addressed problems with certain knee and ankle implants. According to the letter, one of the packaging layers for the polyethylene plastic insert did not conform to specifications. These non-conforming bags should have contained an additional barrier » Read More