Posted on December 26,2014 in Arlington Heights Defective Medical Device Attorney

Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant designed to strengthen a weakened vaginal wall in the instance of POP or to reinforce the urethra to treat SUI. In 2011, the FDA issued a follow-up of its health notification from three years previous, which alerted people to the complications linked to transvaginal mesh when treating either of these medical conditions.

The updated safety alert identified additional concerns and growing numbers of reported difficulties involving surgical mesh devices. From the time between the initial communication in 2008 through to the end of 2010, the FDA recognized that complications were continuing at a high rate and were not considered a rare occurrence. More than 1,500 additional cases involving transvaginal mesh for POP repairs were documented and nearly 1,400 reports were linked to repairs for urinary continence.

According to The Harvard Medical School, over 1 in every 10 women will undergo prolapse surgery by the time they turn 80 years of age. Prolapse may be discovered during regular pelvic exams or carry symptoms including:

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 Posted on December 17,2014 in Defective Prescription Drugs

The results from a new six year study may bring hope for those who have been forced to use dangerous drugs like statins to lower their cholesterol levels.

Whereas statins reduce LDL cholesterol by preventing it from being made, ezetimibe achieves the same result by preventing LDL cholesterol from being absorbed. The study, discussed at the annual meeting of theAmerican Heart Association, separated subjects into two groups – a group given statins and a group given the new drug ezetimibe. The statin group ended with an LDL of 69, while the ezetimibe group had an average LDL of 54. The second group also suffered 6.4 percent fewer cardiac incidents, such as heart attacks, strokes, and severe chest pain. One prominent observer called the outcome “fantastic” and “a truly spectacular result for patients.”

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 Posted on December 12,2014 in Defective Prescription Drugs

Thrombosis, or blood clots as they are colloquially known, tend to manifest naturally in men more than women. Women, however, are at risk for blood clots primarily because of pregnancy, birth control, and other hormonal therapies men do not generally take, according to StopTheClot.org.

Birth control pills are the most common form of contraceptive used in the U.S., and carry a high risk of blood clotting. Women who take birth control pills are generally three to four times more likely of developing a blood clot than women who do not take the pill.

It should be noted that the chance of a woman developing a blood clot as a result of taking birth control pills is still relatively small. Only about one in 3,000 women develop a blood clot because of birth control, but if a woman has a history of thrombosis in her family, the risk increases significantly.

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 Posted on December 10,2014 in Defective Prescription Drugs

Side effects of certain medication can put people at high risk for harm, increasing pain, and long-term medical conditions. It is the responsibility of drug manufacturers to make publicly known the severity of side effects its products may cause.

One of the highest-selling medications, Levaquin, secured record high sales in 2012 with $1.5 billion worth of prescriptions sold, according to Forbes. The antibiotic is prescribed to patients to treat conditions such as:

• urinary tract infections;
• pneumonia;
• acute bacterial sinusitis; and
• skin infections.

A little over a year ago, the U.S. Food and Drug Administration (FDA) issued a drug safety warning about the risks Levaquin carries. The administration required updates to drug labeling and medication guides to include a better description of one of the major side effects of taking the medication: peripheral neuropathy.

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 Posted on December 05,2014 in Arlington Heights Defective Medical Device Attorney

With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition. There are several types of biopsies, according to WebMD. A surgical biopsy is one of the most common, and one of the most dangerous. In a surgical biopsy, a surgeon will either remove a part of tissue or a whole lump of tissue.

Because of the sensitive nature of biopsies, especially in cases in which a patient may already be ill or injured, equipment used in the procedure must be painstakingly considered. When biopsy medical devices are recalled, it can be a very serious issue for any patient involved. One such recall issued in 2011 just recently expired, but not before implicating thousands of patients. In 2011, DeRoyal Industries, based in Tennessee, issued a recall of their Geomed Biopsy Tray, an all-inclusive tool kit used by surgeons to perform the invasive procedure. According to the U.S. Food and Drug Administration, there were several products included in the tray that were potentially contaminated, including triad lubricating jelly, alcohol prep pads, and alcohol swabs.

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 Posted on December 02,2014 in Acetaminophen

A breakthrough in the medical community came for migraine sufferers this November, according to MedicalXPress.com. A study from Case Western Reserve School of Medicine found that nerves in the brains of patients who suffered migraines show abnormalities of the “myelin sheath that serves as insulation around nerve fibers,” MedicalXPress.com reports. The study involved observing 15 patients who underwent a surgical treatment that attempted to reduce the negative effects of serious migraines, and included electron microscopy that assessed the structure of cell nerves in patient's brains. The study also examined the presence and function of cranial proteins in migraine patients.

Ultimately, the study found that patients whose myelin sheath was damaged were more likely to suffer migraines. As a result, one doctor in the study “developed migraine surgery techniques after noticing that some migraine patients had reduced headache activity after cosmetic forehead-lifting.” This type of cosmetic surgery removes some of the muscle and vessel tissue surrounding cranial nerves.

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 Posted on November 28,2014 in Defective Prescription Drugs

Pradaxa is a blood thinner, which was approved by the FDA in 2010, and prescribed to prevent blood clots in patients not suffering from a heart rhythm abnormality. Over a period of 11 months, an estimated 1.1 million prescriptions were written for the medication.

Since then, the FDA has issued multiple safety warnings about the potential of serious risks the use of Pradaxa carries for patients. Post-marketing reports have pointed to serious bleeding, some of which may lead to fatalities, occurring in patients taking the blood thinner.

The New York Times reported in 2012 that unlike warfarin, an older blood thinner, there is not an antidote to reverse the blood-thinning effects of Pradaxa and over 500 deaths had been linked to the drug. In the same month, the FDA issued an additional safety announcement stating that Pradaxa should not be used to prevent stroke or blood clot in patients with mechanical heart valves.

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 Posted on November 26,2014 in Defective Prescription Drugs

A number of studies have linked certain SSRIs to birth defects when taken during pregnancy. Celexa is a SSRI typically prescribed as an antidepressant, but has been shown to carry risks when taken by women who are pregnant.

The FDA issued drug safety information alerting women of the risk Celexa poses when taken during pregnancy. Its warning was based on analysis of a published study identifying babies born to mothers taking SSRIs like Celexa as six times more likely to suffer from persistent pulmonary hypertension (PPHN) following the 20th week of pregnancy.

PPHN occurs when blood does not flow by the lungs in newborn babies. Symptoms of the condition include:

• rapid heart rate;
• blue tint to the skin; and
• rapid breathing or difficulty in breathing.

Five years after the FDA warning, the U.S. National Library of Medicine published a study linking prenatal exposure to Celexa to neural tube defects. Two of the most common neural tube defects, which can develop in the first month of pregnancy, are spina bifida and anencephaly. These types of birth defects can lead to paralysis or death shortly after birth, respectively. The study also found fetal alcohol disorders were 10 times more common in babies exposed to SSRIs during pregnancy than those who were not.

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 Posted on November 19,2014 in Defective Prescription Drugs

Many risks of anti-depressants are relatively well-known and publicized. One of the most common side effects of anti-depressants occurs when expectant mothers take them. Selective Serotonin Reuptake Inhibitor antidepressants (SSRIs) have a very high risk of resulting in birth defects in a newborn, reports the National Library of Medicine, part of the National Institute for Health (NIH).

By some estimates, between 20 and 30 percent of newborns who are “exposed to SSRIs towards the end of gestation have disorders such as agitation, abnormal muscle tone and suction, seizures and hypornatraemia.” This research was first made public in late 2005, according to NIH, and immediately pregnant women who were taking SSRIs were advised to seek alternative therapies and, in some cases, even encouraged to reevaluate the diagnosis.

And yet birth defects, while perhaps the best-known side effects of SSRIs, may not be the most severe or serious. According to a publication from the Harvard Medical School, SSRIs can also result in serious physical symptoms ranging from insomnia to stomach issues, skin rashes, and joint or muscle pain. The risk of internal bleeding is approximately the same as it is with NSAIDs, found in common medications such as aspirin and naproxen.

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 Posted on November 14,2014 in Arlington Heights Defective Medical Device Attorney

An international group of scientists recently condemned Metal-on-Metal hip replacement implants. A report issued by the European Commission's Scientific Committee on Emerging Newly Identified Health Risks concluded that metal-on-metal (MoM) devices should be “avoided” due to their “high failure rate.” Researchers stated that MoMs should be used only on a case-by-case basis, in light of other, more effective available alternatives. For those patients who had already received these devices, the report recommended ongoing followup visits with the surgeon, especially in the first five years when the devices are most prone to failure.

The 14-member SCENIHR is based in Luxembourg. Ten noted experts from Western and Central Europe contributed to the report.

Metal-on-Metal Hip Implant Lawsuits

In the United States, Biomet, DuPuy – which is a division of Johnson and Johnson – and other device manufacturers have all been the subject of defective hip implant litigation in Illinois and elsewhere. Hip replacement surgery is quite common among middle-aged and older adults, as the joint naturally deteriorates.

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