Posted on June 19, 2014 in Defective Medical Devices

Arthritis can turn into a debilitating disease, no matter the age of the sufferer. However, arthritis patients can be medically treated to help continue with the performance of daily activities. One such arthritic treatment method is a hip replacement implant known as A.S.R. or the “articular surface replacement,” and it is manufactured by DePuy, a subsidiary of Johnson & Johnson.

The A.S.R. product launched in 2003, yet it is noted that clinical trials were not performed before the A.S.R. product was released. During a period of six years, 93,000 patients received the implants. One-third of those patients were from the United States. However, doctors began to see issues shortly after the product launched. Several called for the product to be taken off the market but sales continued into 2009. In 2010, the A.S.R. product was removed from the market after a worldwide recall was issued.

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 Posted on June 17, 2014 in Defective Drugs & Treatments

A recent study, published by AdverseEvents.com, has found that a new class of diabetes treatment drugs may have serious side effects and are not necessarily being touted by the drug manufacturer or the doctors administering them. In April, AdverseEvents suggested a comparable safety research (CSR) study to offer a counterpoint to the report issued by the drug manufacturer. AdverseEvents released a publication using the proposed CSR framework regarding Type 2 Diabetes medication and found that while the drugs can be effective, they may have highly adverse and narrowly published side effects.

The drugs included in the study are GLP–1 Agonists, DPP–4 Inhibitors, and SGLT–2 Inhibitors. All drugs are manufactured by industry heavy-hitters, and while each has been tested in the lab for adverse side effects, none were formally analyzed by the drug company once they were dispersed for wide use. AdverseEvents CEO, Brian Overstreet, told DrugWatch.com that the only way to truly track the potential negative side effects of a drug is to monitor its effect on real patients in the real world.

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 Posted on June 05, 2014 in Defective Products

Sometimes the most common household items can be the most dangerous products, often made even more so because information regarding their dangers is not widespread or readily available. One of these is talcum powder—commonly known as baby powder.

In the 1970s the first report on the dangers of talcum powder was published. The report found a link between talc particles and ovarian cancer, according to The Huffington Post. Not surprisingly, the medical director for Johnson & Johnson (a leading talcum powder manufacturer) vehemently contested these findings.

For years, The Huffington Post reports, women were encouraged to put talcum powder on themselves as a way to "mask alleged genital odors." It was not until 1992 that a report in Obstetrics & Gynecology stated that a woman's risk of ovarian cancer was increased three times if she frequently used talcum powder. Since then, more than a dozen other reports have substantiated these findings.

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 Posted on June 03, 2014 in Defective Medical Devices

Morcellation devices are used to remove uterine fibroid growths that are common in women. They are non-cancerous growths that appear in the smooth muscle tissue in the uterus. If these fibroid growths are not removed, they can cause serious health issues for the affected women.

Uterine tissue is divided into smaller segments so it can be removed through an incision in the abdominal area of the body. A morcellation device is small enough to go into the body to perform this work. This medical device has recently been recalled by the FDA because it has been linked to the spread of undiagnosed cancer throughout the body.

FDA Warning

The FDA found that one in 350 women who receive myomectomy procedures for uterine fibroids also have an undetected cancer of the uterus known as uterine sarcoma. The FDA warned against the use of the morcellation device due to the increased risk of cancer spreading throughout the body.

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 Posted on May 30, 2014 in Defective Medical Devices

Boston Scientific (BSX) recently announced that it received a subpoena on May 5 from the Department of Health and Human Services. The subpoena asked the company for information about the performance of its implanted defibrillators. Defibrillator devices are used to shock racing hearts back into a normal rhythm during cardiac emergencies, some of which may injure patients.

The subpoena requested information from 2008, when Boston Scientific released two different types of implanted cardiac defibrillators. The documents also asked for information regarding the performance of these two devices when used between 2007 to 2009. The defibrillators are sold using the names Teligen and Cognis and are implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

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 Posted on May 21, 2014 in Defective Medical Devices

There is no shortage in advertisements seeking those who have been injured during the use of medications or medical devices. As a result, the FDA is pushing for stronger guidelines when it comes to the postmarket surveillance of these products in an effort to reduce the number of defective devices used by patients.

The reason for this action is to lower the number of recalls and reduce injury to patients. Postmarket surveillance is important because most drugs are approved based on clinical trials of the products. Clinical trials apply to a small control group that are selected by the manufacturer. This control usually does not have other medical ailments besides the one that the drug is designed to treat. Yet this will not be true of the general populous.

Postmarket surveillance then continues to monitor the performance and safety of the drug or product once it is released to the general populous who may have addition and varied medical conditions. Information is gathered through various databases, event monitoring for prescriptions, and patient registries. It is then gathered and compared through data mining and will be further be reviewed to uncover any potentially dangerous safety concerns.

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 Posted on May 15, 2014 in Defective Medical Devices

Drug companies have attempted to capitalize on a market of men interested in improving their libido and life satisfaction with a treatment known as Low-T testosterone therapy. But that treatment is raising eyebrows from the FDA. With increased scrutiny surrounding defective medical devices and treatments amidst reports of heart problems from patients who have undergone the therapy, the FDA stands poised to evaluate the manufacturing companies.

Two studies about such therapies have already found that the treatment increases the risk of heart attack, stroke, and death. A patient contemplating receiving the therapy should fully investigate the claims from other patients and really consider whether it is worth taking on such a major risk.

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 Posted on May 12, 2014 in Defective Drugs & Treatments

Official warnings have been handed out to several companies advertising autism therapies and cures. Five total treatments were flagged in the statement from the FDA, which was announced during Autism Awareness Month. While some of the therapies are noted as useful medical therapies, there have not been scientific studies that show a connection to autism improvement. Giving families false hope is just negative impact of companies peddling defective medical devices or treatments.

One treatment, known as hyperbaric oxygen therapy, deploys a pressure chamber to administer high oxygen levels to a patient. Although it is widely used for decompression sickness, there is no research that it is an effective or safe treatment for autism. Chelation therapies, too, have been criticized because patients may suffer from kidney failure or even death through the process in which heavy metals are drawn out of the body.

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 Posted on May 07, 2014 in Defective Medical Devices

The total number of defective medical device recalls in the past decade represents a significant increase, and it raises the question of whether more people are reporting issues or if there are simply more design defects putting patients at risk. Defective devices can injure patients and cause serious physical and mental repercussions when the device does not operate properly.

There are several reasons behind the increase recall numbers, according to Steve Silverman, director of the medical device compliance center at the FDA. Educational workshops and tough FDA inspections have increased the number of devices being pulled from the market, although many of these devices have already caused numerous patient problems long before they are officially recalled. Easier processes for reporting an increased belief in the importance of journaling problems early could be partly behind the increased recalls. However, the jump still raises overall concerns about device safety.

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 Posted on May 05, 2014 in Defective Medical Devices

The FDA recently launched a comprehensive investigation into the “low T” testosterone therapy program. Early research indicates that men may face a higher risk of premature death, stroke, or heart attacks by undergoing this therapy. This is just the latest in a string of defective medical devices and treatments, being investigated by the government, that end up harming patients. For some patients, it is too little, too late.

The evaluation of the therapy was launched after two large studies were found to increase the likelihood of a cardiovascular incident. The federal agency is now exploring whether the possible benefits of the therapy are outweighed by the potential negative impacts on the male patients who use it. At present, these drugs are only advised for men who have low T and a linked medical condition. However, research shows that some men may be undergoing the therapy without actually needing it.

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