Posted on August 26, 2014 in Defective Medical Devices

The Infuse Bone Graft, manufactured by Medtronic, is one medical device that has come under fire in recent years for Medtronic's failure to appropriately warn patients of associated risks. According to Medtronic, the device consists of two parts. One part is a protein found in all human bodies. The other is the device itself—the delivery carrier. The protein found in the device is associated with bone growth and healing. Medtronic notes that the Infuse Bone Graft eliminates the need for a second bone surgery to remove a part of a bone for fusion with another. Clinical trials show that when the Infuse Bone Graft was surgically placed where bone growth was needed, it only grew bone in the site of placement, not in other parts of the body. This device is used most for spinal-repair surgery.

However, The Wall Street Journal reports that the device is linked to life-threatening complications for dozens of patients. Yet many of the complications, states The Wall Street Journal, “occurred during 'off label' uses,” when doctors were using the devices for unapproved purposes. The Food and Drug Administration (FDA) warned surgeons of risks when the device was used on the spine near the neck. “The agency said it received 38 reports over four years of side effects,” which were mostly swelling of the neck and throat tissue. This resulted in patients reporting difficulty breathing, speaking and swallowing. Some ended up requiring “tracheotomies and the insertion of feeding tubes, as well as second surgeries,” notes The Wall Street Journal.

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 Posted on August 19, 2014 in Defective Medical Devices

Having a hip replaced is one of the most risky and complicated surgeries a person can undergo. It is also one of the most common bone replacements that are undergone in the United States. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), there are several reasons why a person would undergo a hip replacement surgery.

Goals of such surgery include:

• Increasing of mobility in patients who feel as if their mobility has been limited by a diseased hip;
• Improving the range of movement or function of the hip joint; and
• Reducing pain in patients who suffer from a diseased hip.

The NIAMS reports approximately 332,000 total hip replacements are performed annually in the U.S. However, doctors will most likely not consider a hip replacement unless the patient has tried other less-invasive methods of rehabilitation. These methods can include exercise, walking aids and medication. NIAMS notes, “Walking aids such as canes and walkers may alleviate some of the stress from painful, damaged hips and help you to avoid or delay surgery.”

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 Posted on August 15, 2014 in Defective Prescription Drugs

A report first published last October by the U.S. National Library of Medicine and the National Institute of Health found that medication taken to treat hyperthyroidism in pregnant women led to birth defects. The report was based on a study which examined more than 815,000 children born between 1996 and 2008. Those who were exposed to hyperthyroid medication early in the pregnancy were more likely to experience birth defects. However, the spectrum of malformations varied considerably.

Drugs used to treat hyperthyroidism are shorthanded as ATDs. According to UpToDate.com, most antithyroid drugs (ATDs) have few risks and side effects. Patients who have an overactive thyroid can have the condition permanently or temporarily. An example of permanent hyperthyroidism would be that brought on by Grave's disease. On the other hand, pregnant women can experience hyperthyroidism. In these cases, ADTs are given to the women temporarily. The 2013 report suggests that new ADTs should be found for use with pregnant women.

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 Posted on August 12, 2014 in Drugs

A generic drug is an essential option for Americans, as it is sold at a lower cost than a name brand product. In fact, the FDA notes that generic brands can be as much as 85 percent lower in price. However, these lower prices are a direct result of several factors. One of these factors is that generic drug manufacturers are not required to “repeat the costly clinical trials of new drugs.”

With that said, FDA is responsible for protecting public health by “assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” Under the federal Food, Drug, and Cosmetic Act (FDCA), the “introduction or delivery for introduction” of an any adulterated drug “into interstate commerce” is prohibited. However, there are instances where manufacturers, generic and name brand, circumnavigate the protections in place and thus manufacture, and even distribute, faulty drugs.

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 Posted on August 10, 2014 in Defective Medical Devices

Heart surgery and the implementation of a heart device are very serious procedures. According to the New York University Langone Medical Center coronary revascularization is one of the most risky heart procedures for patients; however, it is recommended for heart failure patients who have a varying degree of severity of heart problems.

Other types of risky heart procedures include septal myotomy and ventricular restoration. Septal myotomy is conducted to remedy a disease of “unknown origin that causes the heart muscle to thicken,” limiting the heart's ability to pump blood. Ventricular restoration is one of the most common as it is conducted to help restore the functions of a patient's heart after he or she suffers a heart attack.

In addition to these risky surgeries—all which carry a high risk in patient complications—there are a number of heart implant devices that also carry high risk. According to Medscape.com, a recent review of “cardiovascular device approvals in the U.S. suggests only a minority are ever tested against standard treatment” before they are approved for sale in the U.S.

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 Posted on August 05, 2014 in Vaccination Injury

The human papillomavirus (HPV) is one of the most common sexually transmitted diseases in America. Not only is HPV associated with genital warts, it is known to cause cervical cancer in women and other types of cancers in men. Several years ago, the development of a vaccination to protect against the transmission of HPV was announced. There are currently two vaccinations for HPV being manufactured: Gardisil and Cervarix.

The CDC recommends that all boys and girls should finish the three HPV preventative shots by the time the time they are 11 or 12 (earlier if they are known to be sexually active) to help prevent the spread of the disease. However, according to Women's Health Magazine, early research into Gardasil and Cervarix showed that neither drug was entirely effective five years after the three-dose vaccine was administered. Cervical cancer is a slow-growing cancer, so for a vaccine to truly be effective it would need to be so for at least 15 years. “In the absence of long-term studies,” Women's Health reports, “scientists can not say whether women who have received the shots will need to be poked again later.”

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 Posted on July 29, 2014 in Defective Medical Devices

Transvaginal mesh implants have often come under fire in recent years for faulty manufacturing and patient complications. Urogynecologic surgical mesh implants are used to provide support for organs and tissues that are weakened or damaged. They are made of synthetic materials that are often absorbable, or a combination of both absorbable and non-absorbent materials, according to the U.S. Food and Drug Administration (FDA). They are used specifically to treat pelvic organ prolapse and stress urinary incontinence. There are three types of urogynecologic implants: transabdominal mesh, a mesh sling, and a transvaginal mesh implant. While each has its own risk, transvaginal mesh implants are arguably the most risky.

In 2008, the FDA issued a public health notification to healthcare practitioners about the dangers of transvaginal mesh implants. At that time, the FDA had received more than 1,000 reports from nine different surgical mesh manufacturers of serious complications during surgery and recovery. Healthcare providers were, at that time, urged by the FDA to inform patients of the risk (including serious side effects such as pain during sexual intercourse and the narrowing of the vaginal wall), and provide patients with a written copy of the manufacturer's label.

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 Posted on July 24, 2014 in Defective Prescription Drugs

Several forms of testosterone therapy have come under fire lately due to concerns for patient safety. According to WebMD, while the practice of prescribing hormonal therapy treatment to men with low testosterone has recently become more and more common, the long-term safety and side effects are not yet clear.

This year, the Food and Drug Administration (FDA) announced that it now requires such products to add a general warning about potential blood clots in the veins that are known to occur with certain testosterone therapies. Other therapies are known to result in negative side effects for the heart.

A study published by PLOS ONE has found “a twofold increase in risk of nonfatal heart attack shortly after initiation of testosterone therapy,” when used by men under the age of 65 who suffer from heart disease. However, it is noted that men, ranging in the millions, utilize testosterone as a lifestyle drug as a means to reverse the natural testosterone decrease men experience as they age.

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 Posted on July 21, 2014 in Defective Prescription Drugs

Diabetes is one of the most common debilitating diseases in the U.S. today, and according to the National Diabetes Education Program (NDEP), an estimated 8.3 percent of the population suffers from diabetes, roughly 25.8 million Americans. However common, the disease is one of the least discussed conditions to affect so many people. In fact, the NDEP reports that an estimated 7 million people with the disease are not aware that they have it. Nearly 2 million people are diagnosed with the disease annually.

The two most common types of diabetes are Type 1 and 2. Type 1 was previously identified as early-onset or juvenile diabetes. Type 2 is by far the most common, and accounts for approximately 90 to 95 percent of all diagnoses. There is no cure for either type of diabetes, though studies have proven that regular exercise and weight loss can help prevent or delay the onset of the disease for many people. Despite these easy ways to help mitigate the effects of diabetes, the disease still costs the nation an estimated $116 billion in direct medical costs (such as hospitalizations, medical care, and treatments) every year. An additional $58 billion is spent annually on indirect costs associated with diabetes, according to NDEP, such as disability payments, time off work, and early death.

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 Posted on July 18, 2014 in Illinois Defective Medical Products Lawyer

Testosterone therapies for men with low levels of the hormone have become increasingly popular in recent years. The American Medical Association issued a report in 2013 that stated that between 2001 and 2011, “the use of hormones among men over 40 increased by almost 360 percent,” as noted by Fox News. These types of therapies, while very popular, come with high associated risks—mostly involving heart failure and function. These are serious side effects for a therapy this common, and many doctors and members of the medical community have started to question whether testosterone therapy is the best option for men with symptoms it is meant to cure.

Symptoms publicized or advertised as those that need testosterone therapy to cure are often simply relative to the normal aging process. This is one reason critics are speaking out against the procedures. Advertisements aimed at men who “need” testosterone therapy asks if the viewer is suffering from symptoms such as low energy, weight gain, fatigue, low sex drive, and depression. “Really, at midlife,” The Washington Post asks, “who isn't?”

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