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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 Posted on July 15,2014 in Vaccination Injury

Since 1988, the first year in which such records were kept, there have been more than 15,000 claims filed in the United States for personal injury caused by vaccination. The year with the highest number of cases filed was 2003, in which nearly 3,000 claims – one-fifth of the aggregate total – were filed, followed by 2004. According to theHealth Resources and Services Administration (HRSA), a branch of the U.S. Department of Health and Human Services, the number of claims filed in 2013 (the most recent year for which complete data was available) was 503. As of March 2014, 218 claims had been filed. These types of claims cost the medical industry hundreds of millions of dollars each year. The most common types of injuries caused by vaccinations are temporary and not serious.

As reported by the History of Vaccines, an initiative of The College of Physicians of Philadelphia, side effects can generally include soreness, swelling, redness, fever, aching, or rash, especially at the site of the vaccine. More serious, life threatening risks of vaccinations are often a result of an allergic reaction.

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 Posted on July 10,2014 in Illinois Defective Medical Products Lawyer

Testosterone therapy has become increasingly popular in recent years as discussions of male hypogonadism have become more commonplace. Male hypogonadism occurs when a man has low levels of testosterone, shorthanded as low T.

To help overcome low T levels, men undergo testosterone therapy to help the body produce the correct levels of hormones that it would not otherwise sufficiently produce.

According to DrugWatch.com, testosterone therapies are an extremely popular treatment, yet recent research has shown that these types of therapies are inextricably linked to higher risks of heart failure and attacks.

The problem, according to DrugWatch.com, is that more than four times as many men were taking these drugs in 2011 as compared to 2000. “Experts estimate that sales of these products could reach $5 billion by 2017.” It is estimated that men in the U.S. collectively spend more than $2 billion annually on low T therapy.

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 Posted on July 08,2014 in Birth Defects

Several years ago reports were released regarding antidepressant medications and the link to birth defects. In 2009, noted by WebMD, a study reported that women who take antidepressants during pregnancy may risk that their baby will have a heart defect. And the risk of the baby being born with a defect is greater when the used antidepressant is a selective serotonin reuptake inhibitor (SSRI). The same goes for moms who switch to an SSRI antidepressant medication early in the pregnancy. Many women experience hormonal changes during pregnancy are prescribed antidepressants as a result. However, it was not clear in the study if all SSRI medications led to the increased risk of heart defect.

In 2005, the U.S. Food and Drug Administration (FDA) issued warnings about Paxil, an antidepressant similar to the more widely used Zoloft, Celexa, or Prozac. The study found no link between heart defects in babies whose mothers were taking Prozac or Paxil. But, it did find a correlation in mothers taking Celexa or Zoloft. That study, which examined more than 400,000 babies between 1996 an 2003, found that “septal heart defects occurred in 0.5 percent of children born to mothers who did not take antidepressants and 0.9 percent of children born to mothers who did.”

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 Posted on July 02,2014 in Drugs

A recent Health Professional Follow-Up Study (HPFS) has found that erectile dysfunction drugs (such as Viagra) are linked to an increased risk of a dangerous type of cancer. The study showed that men who were taking Viagra were nearly 85 percent more likely to develop melanoma (a fatal type of skin cancer) than those who were not. Men who had previously taken Viagra and had ceased taking the drug were still twice as likely to develop melanoma than men who had never taken it.

The active ingredient, or clinical name for Viagra, is sildenafil. The drug, researchers found, “affects cell pathways that allow melanoma to spread (metastasize) to other parts of the body,” reports Drugwatch.com. This type of skin cancer is responsible for nearly 10,000 deaths annually in the U.S., and an estimated 76,000 cases of melanoma are diagnosed in the same time period.

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 Posted on June 29,2014 in Drugs

In June, the Food and Drug Administration (FDA) issued a statement requiring drug-makers who manufacture testosterone to issue a warning label on the drug regarding the potential risk for venous blood clots.

Testosterone replacement drugs are a medicinal therapy for men with erectile dysfunction, though according to WebMD, “inadequate production of testosterone is not a common cause of ED.”

The natural decline of testosterone in a man's body begins after age 30, but there are several causes of lack of testosterone production. Reasons for inadequate testosterone production include (but are not limited to):

• Injury or infection of the testes;
• Genetic abnormalities;
• Chronic illness or kidney failure;
• Liver cirrhosis;
• Alcoholism;
• Inflammatory diseases;
• Chemotherapy or radiation; and
• Obesity.

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 Posted on June 27,2014 in FDA

The Food and Drug Administration (FDA) recently announced that it is conducting a pilot program to expedite drug recall notifications in an effort to quickly and efficiently relay important information to the public. The Agency, according to the FDA, currently issues a weekly Enforcement Report for consumers to be informed about the risks posed by products on the market. And in April, the Agency released a report on how to increase public access to such enforcement reports to ensure public access.

To do this, the FDA appointed eight focus groups, as detailed in the 2014 Transparency Report, with each group representing a center of the Agency to ensure that no significant function was left unwatched. One such initiative to come out of the focus groups was the decision that all agency groups will now, and moving forward, submit information electronically, and keep all electronic information stored in one place. This thus establishes “a single authoritative source for facility identifying information” and ultimately makes it easier for consumers to know where to look to check on product recalls, and also where to submit information. The FDA relies on consumer reports to stay on top of all the different products and services it regulates. Ensuring that consumers know where to go, as well as an ease to report faulty products, makes it easier for the FDA to do its job.

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