Posted on September 15,2014 in Defective Medical Devices

In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).

The FDA clearly states that when used for either purpose, the morcellators “poses a risk of spreading unsuspected cancerous tissue” beyond the uterus and into the bloodstream. As such, the agency discourages the use of morcellators but does not outright forbid their implementation. This is what New York Senators Chuck Schumer and Kirsten Gillibrand are attempting to quell.

According to an article in Modern Heathcare, in August Senators Schumer and Gillibrand wrote a letter to the FDA requesting that the agency to remove the morcellator devices from the market. The letter, reports Modern Healthcare, cites a recent survey done at Boston's Brigham and Women's Hospital which found that women who had morcellators implemented were at a nine times higher risk of having the cancer spread than what was communicated to them at the time of surgery.

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 Posted on September 12,2014 in Defective Prescription Drugs

When the antidepressant drug Paxil hit the consumer market in the early 1990s, it was hailed by the medical world as a wonder drug, able to relieve even the most severe cases of mental depression. Like most other antidepressants, Paxil is a selective serotonin reuptake inhibitor (SSRI). There have been widely-publicized side effects about SSRIs for the patient who takes them. However, not as much has been published about the effects SSRIs can have on babies born to women who are taking them.

According to the U.S. Food and Drug Administration (FDA), the first such warning was in fact issued as early as 2005, when the FDA advised the medical community to discontinue the practice of prescribing Paxil to pregnant women. In 2005, however, the FDA maintained that women who were already on Paxil may face a greater risk to the fetus by discontinuing the medication than by continuing to take it.

This has changed. According to a recent article in The New York Times, the risk of taking SSRIs during pregnancy could be far worse for the fetus than the risk of being depressed. Women, reports the The New York Times, go to great lengths to give their baby the best start to life: they often quit smoking, give up drinking, and decline foods like Brie cheese and swordfish. Yet these same women often do not give up SSRIs, “despite an increasing number of studies linking prenatal exposure to birth defects, complications after birth, and even developmental delays and autism.” A recent study out of John Hopkins University found that young boys with autism were more than 30 percent more likely to have been exposed to SSRIs via their mother during prenatal development.

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 Posted on September 09,2014 in Defective Prescription Drugs

The U.S. Food and Drug Administration (FDA) recently issued a warning to physicians across the country not to use any compounded drugs that were manufactured by Unique Pharmaceuticals because of possible contamination. This action was done in response to an FDA inspection of the company's Temple, Texas manufacturing plant, where inspectors found issues with medication production that may have compromised the sterility of the medication.

Unique Pharmaceutical issued a voluntary recall of all its sterile compounded medications that have not yet expired and are advising that all products be returned to the company. The products were contained in vials, bags and syringes. Non-sterile items manufactured by the company are not affected by the recall. In the warning to consumers, the FDA said that patients who use sterile items that may have been contaminated are at risk of serious and possibly fatal infections.

Compounding pharmacies manufacture customized medications that have been ordered by doctors. According to the International Academy of Compounding Pharmacists (IACP), out of the almost 56,000 compounding pharmacies in the country, approximately 7,500 offer “advanced compounding services.” About 3,000 of them manufacture sterile products.

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 Posted on September 05,2014 in Testosterone Therapy

Testosterone therapy entices its users with the promise of increased muscle mass, boosted libido, increased energy levels, and sharpened concentration and memory. As men age, they begin to see testosterone therapy as a viable option to help them get back some of their youth. Testosterone therapy involves the taking of testosterone medicines to increase one's testosterone levels. However, as the different types of testosterone therapy products on the market increase, so has the increase in defective drug claims.

In Illinois, testosterone therapy claims were filed earlier this year, and many believe that there are many more on the way. Some of the many arguments from plaintiffs have been that they were insufficiently warned about the serious risks associated with testosterone therapy. These risks include blood clots, heart attacks, and strokes. More specifically, these suits argue that testosterone manufacturers and producers have created deceptive and aggressive product marketing campaigns in order to entice consumers to engage in testosterone therapy. Furthermore, testosterone therapy products pose a particular problem for diabetics. Such therapies dramatically decreased blood sugar levels, which, for a diabetic, can cause rapid heartbeat, dizziness and blurred vision.

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 Posted on August 29,2014 in Defective Medical Devices

Bayer Healthcare Pharmaceuticals, a manufacturer of Mirena Intrauterine Devices (IUD) birth control, has faced several lawsuits in recent years for alleged complications that arise from having used the device. Earlier this month, Mirena made headlines in Bergen County, New Jersey, where nearly 1,000 new lawsuits were filed to date against the manufacturer. The lawsuits allege serious injuries due to “spontaneous migration of the IUD” in those who had the device implanted. Noted injuries include “uterine perforations, organ damage, scarring, and infertility.” There are an additional 600 similar lawsuits pending in southern New York.

An intrauterine device is a long-term contraceptive that is implanted into a woman's uterus. It can only be implanted by a certified medical provider, and has been in use since it was approved by the Food and Drug Administration (FDA) in 2000. It was not until nine years later that the device was approved for use in women with extreme heavy menstrual bleeding. That same year, however, the FDA warned Bayer that their promotion of the intrauterine device did not adequately warn patients of the risks and overstated the benefits of using this type of birth control.

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 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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