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Defective Medical Device Injury Attorney

Fighting for those injured by defective medical devices in Alabama and Nationwide

Defective Medical Devices Legal Overview

The medical device industry is highly competitive. This means many medical products are rushed to market. Often times adequate testing and proper consideration of the potential harm that these products could cause is overlooked. Device makers sometimes use loopholes in the U.S. Food and Drug Administration’s regulations to gain clearance for their products.

One of the loopholes they utilize involves claiming their device is “substantially equivalent” in safety and effectiveness to another device that is already on the market or claiming that their device is being used for the same purpose. The actual use for the device, however, may have been grossly misrepresented.

Time is of the essence. If you have been injured, or your loved one has died as the result of another’s careless conduct, don’t wait, contact us today for a complimentary case review.

What are the Risks from a Defective Medical Device?

In a terrible twist, a medical device that promised to restore health and improve quality of life has done just the opposite, and caused a serious, permanent injury. This is the situation in many defective medical device cases we handle.

When companies put profits above people, lives are destroyed. The manufacturers of medical devices have a responsibility to test their products for safety before they are provided to people and to alert consumers immediately if a problem with their product becomes apparent. Sadly, we often find examples where just the opposite is true.

Several medical devices that have come under recent scrutiny include:

Surgically Implanted Medical Devices

Surgically implanted medical devices are designed to improve a patient’s quality of life. However, sometimes problems arise that lead to complications, pain, illness and even death. These include infection, inflammation, and rejection of the implant. Sometimes, the tissue around the surgical site can become severely infected and there may be a risk of tissue death or blood infection.

Some devices may lead to serious injury or death as a result of a product defect. Device failure can have a lasting impact on a patient’s health. Many failed devices are recalled by the manufacturer. Surgically implanted medical devices that have failed in the past include silicone breast implants, hip replacement joints, artificial heart valves, and surgically implanted mesh.

The manufacturers of medical devices have a responsibility to test their products for safety before they are provided to people and to alert consumers immediately if a problem with their product becomes apparent. Defective medical devices may cause serious permanent injury or even death.

Essure® is a permanent birth control device manufactured by Bayer Health care. The device consists of two small nickel alloy coils, which are implanted through the vagina into the fallopian tubes. Scar tissue forms around the coils, preventing sperm from reaching the eggs.

Since its approval in 2002, 750,000 Essure devices have been implanted. Adverse events reported with Essure include migration, leading to perforation of the fallopian tube or uterine wall or embedment in other organs, often requiring hysterectomy or surgical removal; allergic reactions; severe pain; and infection.

Retrievable IVC filters are wire devices implanted in the vena cava, the body’s largest vein, to stop blood clots from reaching the heart and lungs. These devices are used when blood thinners are not an option. Manufacturers include Bard, Cook and Johnson & Johnson.

While permanent IVC filters have been used since the 1960s with almost no reports of failure, retrievable IVC filters were introduced in 2003, promoted for use in bariatric surgery, trauma surgery and orthopedic surgery. Risks associated with the retrievable IVC filters include migration, fracture and perforation, leading to embolism, organ damage and wrongful death.

The 3M Bair Hugger® is a force hot air warming blanket, used primarily to help maintain a patient’s body temperature during surgery. The 3M Bair Hugger pushes warm air through a flexible hose into a blanket draped over a patient. However, warming blankets can recirculate contaminated air over a patient’s body, including over an open surgical site.

This may result in infections like MRSA or sepsis. In particular, patients undergoing knee or hip replacement surgery are at risk of infections deep in the joint, which is very difficult to treat. Complications from these infections include hospitalization, implant revision surgery, limited mobility, permanent disability, amputation and death.

In April 2014, the U.S. Food and Drug Administration (FDA) urged doctors to stop using a medical device called a power morcellator, because studies showed the device may spread cancer. An estimated 1 in 350 women develops uterine sarcoma – a type of uterine cancer – after undergoing a morcellator procedure.

Morcellators are typically used to grind away uterine growths such as fibroid tumors, and in hysterectomies. They became popular as a less invasive surgical alternative. The FDA conducted a formal review of the devices in July 2014 and announced that it’s concerns with the morcellator were confirmed. During this time, Johnson & Johnson announced it would stop selling the surgical tools.

More than half a million Medtronic MiniMed Paradigm® infusion pumps are being recalled worldwide, following reports that suggest programming errors may lead patients receiving wrong dosages of insulin.

Medtronic has received reports that users accidentally programmed the pumps to deliver the maximum amount of insulin possible. An urgent medical device safety information letter (PDF) on the issued by the manufacturer in late July.

Mirena® is an intrauterine device (IUD) that was originally approved by the FDA as an intrauterine contraceptive. It was later approved as a treatment for heavy menstrual bleeding. It works by slowly releasing a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus.

Serious adverse side effects and potentially life-threatening complications have been reported following the implantation of the device. These complications include organ perforation, migration of the IUD to outside the uterus, expulsion of the IUD, and embedment in the uterus, among others.

If you feel you have a defective medical device claim, you may be entitled to compensation. Contact us today for a free, no-obligation legal consultation.

Our Class Action Lawsuit Attorneys Get Results

We believe that every case is an important one and that every client deserves personal attention, compassion and an attorney who will fight for your rights. No matter the extent of the injuries or the type of accident that you have been injured in, do not hesitate to get the involvement of an Alabama personal injury attorney from our firm. Contact us today.

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