Posted on March 14, 2014 in FDA

In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.

Although the FDA has received more reports of complications from women who have gone through the procedure, the federal agency still classifies the risk of adverse events as “low”. In addition to clinical studies, the FDA also reviews surveillance data sources post-market to determine how safe and effective a variety of medical devices are in practice.

Reports submitted to the FDA by consumers are helpful in identifying problems as soon as possible so that if defects or complications are a factor, other patients can be warned before being affected.

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 Posted on March 07, 2014 in Birth Defects

Around the world, selective serotonin reuptake inhibitors (often called SSRIs) are some of the most commonly prescribed depression medications. In the United States, one of the most popular SSRIs given to patients with depression is Zoloft, which has been linked to dangerous birth defects when taken by pregnant mothers. A new study from the British Medical Journal is the latest authority to lend credence to the risks posed by antidepressants.

The researchers, who reviewed a series of seven studies, found that the risk of persistent pulmonary hypertension of the newborn was different based on the period of the pregnancy in which the mother took the medication. When SSRIs like Zoloft were taken in the later stages of a pregnancy, mothers faced an increased risk that their children would be affected by PPHN.

Although researchers noted that the risk was comparatively low, PPHN is a serious condition that no parent wants to face. In this condition, the baby's lungs are unable to properly exchange oxygen and carbon dioxide. As a result, a newborn could have very low blood oxygen levels, possibly causing damage to organs.

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 Posted on March 04, 2014 in Defective Medical Devices

The federal government's Office of the Inspector General has released their 2014 work plan, and medical device scrutiny features heavily in the goals of the organization. The work plan details all of the hospital-related practices and policies, including quality of care, billing and payments, emergency preparedness, and medical device security. The government has taken a larger role recently in oversight on medical devices after previous research has shown some possible major security holes.

The Office of the Inspector General plans to evaluate Medicare claims to analyze the costs of defective medical devices, linking issues to the impact on the Medicare Trust Fund. Government agencies have previously raised concerns about replacement device costs on Medicare payments.

Portable devices, too, are an issue when it comes to security, since protected electronic health information is often stored inside these machines. Security controls will be explored and loss prevention tactics evaluated to determine how much of an exposure risk patients could face.

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 Posted on February 28, 2014 in Defective Medical Devices

Doctors doing surgery at a hospital in Maine made a discovery regarding the Cordis Opt-ease Vena Cava Filter that have led to investigation and defective device recalls for the item.

The filter is supposed to catch clotted blood traveling through the Vena Cava to hold it there so that the clot doesn't travel farther into the heart or lungs. Doctors struggled to remove the filter from a patient who no longer required it, finding that the instructions for insertion and removal were not accurate.

The filter can also be dislodged in the body, which can be identified using x-rays. Surgery will be needed to reposition or replace the filer if this condition occurs. The filter is not designed for long—term use, since it's supposed to be removed after the patient no longer needs it. Difficulty removing the filter can lead to other complications for the patient involved. Recurrent pulmonary embolism is a life-threatening condition.

Upon discovery of this issue, the FDA issued a recall regarding the labeling instructions that affected 33,000 filters in the United States that were distributed between 2010 and 2013.

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 Posted on February 25, 2014 in Illinois Defective Medical Products Lawyer

Although medical device manufacturers are supposed to vet their creations extensively before putting them on the market, some products get in the hands of caregivers or patients when there are dangerous consequences or bugs that haven't been addressed.

If you have been injured by a defective medical device, you could suffer pain, complications, and possibly even have to undergo treatment for whatever problems the device caused. After getting medical treatment for the issue, you need to consult with a defective medical device attorney about your case to ensure that you receive any compensation you deserve, and that the device will not continue to cause issues for other people.

There's another step you should take if you are concerned about the product issues affecting other patients. When device manufacturers or government regulators are not aware of an existing problem, there is more of a chance that other patients could be hurt by the device. That's why the Food and Drug Administration maintains a reporting program for these dangerous products.

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 Posted on February 22, 2014 in Defective Medical Devices

Although adult defective medical devices make the news more often, some of the most dangerous devices are those intended for use with children. With so many products and medical devices on the market for children, it can be difficult for parents to stay on stop of which devices are safe to use with infants.

When your child is injured as a result of a defective device, you may be entitled to compensation. You should schedule a consultation with a personal injury attorney for more information about your case.

The Perrigo Company recently issued a recall for 18 batches of the infant syringe/acetaminophen combination package when it was discovered that some syringes had no markings for dosage. Without a proper dosage meter, the chances of a parent or caregiver accidentally giving the baby too much medicine could result in problems for the child.

This medicine is an over the counter product sold at retail outlets around the country. The medication is intended for use with infants who are suffering from minor aches and pains. If you are a parent who believes you may have received a defective syringe, report your concerns to the FDA.

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 Posted on February 18, 2014 in Defective Medical Devices

According to Science Daily, “hundreds of thousands of hip and knee replacement surgeries are performed in the United States each year.” While these procedures are generally very effective at reducing pain and restoring mobility, there is a high rate of failure of these devices. There is such a high rate of failure, in fact, that Dr. Geoffrey Westrich told Science Daily that he's “seen a sharp increase in the number of people coming in for a second hip or knee replacement, called a revision surgery.” These devices are prone to failure so often that people seeking revision surgery is nothing out of the ordinary. Considering the amount of pain and suffering and general immobility that generally accompanies a replacement surgery like this, the high rate of revision surgery is alarming.

According to Dr. Westrich there are several things a patient who has undergone a hip or knee replacement should look for to ensure that he or she does not need a revision surgery. These include, but are not limited to:

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 Posted on February 14, 2014 in Defective Medical Devices

Every month the Food and Drug Administration (FDA) recalls several products and devices as unsafe for consumption. Many of these never make news, and very few of these ever make a big splash in the mainstream media. This makes determining whether or not you've been affected by a defective product or device difficult.

According to a University of Akron publication, proving that a defective medical device has negatively affected you can be tricky. “The courts seem reluctant,” the paper states,” to find liability without a clear showing of negligence, whether the defendant is the doctor, the hospital, or the manufacturer of the product.” Regardless of FDA efforts to list and regulate the use of devices deemed defective or harmful, thousands of patients are still affected every year.

In 2008, Congressional hearings were held to determine regulatory procedure for medical devices, in an effort to curb the number of people affected each year. The FDA first received the governmental mandate to regulate medical devices in the 1970s. At that time, according to the U.S. Governmental Printing Office (GPO), the Medical Device Amendment was approved, “a statute whose explicit purpose was, 'to provide for the safety and effectiveness of medical devices.'” The law was revisited in Congress in 2008 after the Supreme Court decided in Riegel vs. Medtronic Inc. that “this law preempts State tort claims when a medical device causes harm.” In 2008, concerned members of Congress stated that this ruling “means complete immunity from lawsuits for corporations that endanger consumers with unsafe devices.”

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 Posted on February 11, 2014 in FDA

At the end of 2013, the FDA announced even more Class II recalls for components making up the da Vinci surgical robot system. The robots have already been in the news for numerous errors and concerns shared by patients who have undergone surgeries using these machines. If you have already been injured as a result of a da Vinci surgical robot, you need legal advice from an Illinois defective medical device attorney.

Intuitive Surgical Inc., the developer of the da Vinci robot creator, has been the focus of more than 70 products liability cases involving their product. Their product liability insurance carrier, Illinois Union Insurance Co., is now trying to deny their coverage responsibility on claims that the robot makers concealed the risks and safety concerns associated with the robots.

The latest round of problems with the da Vinci system involves the arms of the instrument, which could suddenly become stuck as a result of friction errors in the machine. Since the arms are such a crucial component of the robots, this can lead to dangerous mistakes in the operating room, one example of which is inaccurate cuts. Previous FDA recalls focused on needle drivers that helped to guide the instruments which were capable of becoming detached mid-operation.

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 Posted on February 08, 2014 in FDA

The healthcare field is the latest in a group of industries that can say “There's an app for that!”. Some of these mobile applications are being scrutinized under the Food and Drug Administration since they can be considered medical devices. Officials from the FDA state that their primary interest in mobile medical applications are those whose “functionality could pose a risk to a patient's safety if the mobile app were to not function as intended.”

Earlier this year, the FDA released much-anticipated guidelines for mobile applications intended for use as medical devices. It's believed that there are more than 40,000 medical apps for smartphones linked to the healthcare industry.

The FDA is currently interested only in regulating those that carry major risks for patients, which they have classified into two different categories: those that serve as an accessory to an existing, regulated medical device and those that make a mobile platform into a medical device. Some examples of those that face the most scrutiny are those were doctors can make a diagnosis based on shared images and those that are used to locate irregular heartbeats.

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