Posted on December 31, 2013 in Defective Medical Devices

A lot has been noted about the dangers of transvaginal mesh implants, most commonly used for pelvic organ prolapse repair and/or stress urinary incontinence, according to the U.S. Food and Drug Administration (FDA). Transvaginal mesh is only one type of surgical mesh used however—a device generally implanted to “repair weakened or damaged tissue.” Another common use for surgical mesh devices is for the repair of hernias. Hernia repair, according to the Wall Street Journal, is “one of the most common surgical procedures [yet it] carries a risk many patients don't consider: chronic pain after surgery.”

According to the Wall Street Journal, more than one-third of patients who undergo hernia repair suffer “long-term chronic pain and restricted movement after surgery.” This type of pain is similar to that experienced by women who have had transvaginal mesh implants, but because a hernia operation is a much more common procedure, this type of device affects more patients. Synthetic mesh, “though better than traditional sutures at reinforcing the abdominal wall, can irritate nerves and carry a slightly higher risk of infection,” according to the Wall Street Journal.

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 Posted on December 26, 2013 in Birth Control

The NuvaRing, a contraceptive device originally marketed as a safe alternative to traditional birth control pills has not been officially recalled, despite rumors that it has been. According to PR Newswire, at the beginning of this year the trial date for 1,000 lawsuits involving the device was extended, “feeding rumors that the vaginal ring contraceptive's manufacturer, Merck, may be ready to enter settlements negotiations,” reports PR Newswire. Approximately 1.5 million women worldwide use the device despite increased risk.

The increased risks of NuvaRing include increased chance of blood clots, pulmonary embolism, and strokes. According to the Huffington Post, the FDA, after clinical trials in which “a healthy woman in her 20s had developed a blood clot—a surprising occurrence that an investigator determined was probably related to the birth control device,” said that the manufacturer needed to include warnings with the NuvaRing packaging. Manufacturer Organon, “adamantly opposed such a statement,” according to the Huffington Post.

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 Posted on December 22, 2013 in FDA

Abbott Diabetes Care, a lead developer and manufacturer of glucose monitoring and testing systems and strips has announced that it is issuing a voluntary recall of certain lots of its FreeStyle and FreeStyle Lite Blood Glucose Testing Strips in the United States. The defective medical device recall was issued on November 27, 2013 after the company found that approximately 20 lots of the test strips may return erroneously low blood glucose readings when used with certain types of FreeStyle blood glucose meters.

When the test strips are used with the older FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter as well as the OmniPod Insulin Management System, they can return incorrectly low readings. The meters in question are older systems that have not been in production since 2010. When used with the newer FreeStyle meters such as the FreeStyle Freedom, FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Meters, test results are not affected. Testing is also unaffected on the FreStyle InsuLinx Blood Glucose Meter, as this device uses a different type of test strip.

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 Posted on December 18, 2013 in FDA

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of approximately 15,000 Medtronic devices used during heart procedures due to a risk of serious injury or death. The recall affects Medtronic Interventional Guidewires and ATTAIN HYBRID Guidewires. According to the FDA, these are the long, thin wires that are inserted through the artery in order to guide the placement of diagnostics or medical devices such as stents. It has been found that the polytetrafluoroethylene coating (more commonly known as Teflon) that helps the wires slide more easily through the artery can detach have the potential to block a blood vessel.

The recall effects lots of the Medtronic guidewires manufactured from April of 2013 onwards. The FDA ordered the recall in October after four serious problems were reported, including one that involved a patient who suffered cardiac arrest, but was resuscitated. The company has contacted regulators worldwide and halted any new shipments of the wires.

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 Posted on December 13, 2013 in Birth Defects

Isotretinoin, also known as Accutane and one of the most effective medications for acne, is reported to cause severe birth defects to an exposed fetus. Because of this, the U.S. Food and Drug Administration created the computer-based risk management program iPledge, requiring women to review educational materials, complete tests and pledge to use two forms of birth control prior to using the drug.

However, a recent report indicates that the iPledge program been less than successful, and a small study suggests the focus be placed on more highly effective birth control methods. Dr. Eleanor Bimla Schwarz, director of the Women's Health Services Research Unit of the Center for Research on Health Care at the University of Pittsburgh and the senior author of the study, stated, “What we found is that people need a clear message about what birth control would be most effective, and currently the iPledge materials don't make it clear to most women who enroll in the program.” Schwarz also told Reuters Health that women who take isotretinoin need more information on IUDs and implants to better protect themselves from pregnancy.

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 Posted on December 10, 2013 in Defective Medical Devices

If you have ever experienced painful side effects due to a defective medical device, drug or vaccination, you are not alone. Consumer Reports notes that “tens of millions of Americans live with medical devices implanted in their bodies,” including artificial joints, heart defibrillators and surgical mesh. And while Americans may assume that these devices have been tested for safety and effectiveness, Consumer Reports indicates that this is rarely the case. However, there is a free mobile app that allows you to report any device or drug problems and complaints directly to the FDA.

The MedWatcher app, available in both the Apple iTunes and Google Play stores, is the only app that allows users to track and report negative side effects, obtain recalls, and receive government safety alerts. Users also receive reports of the side effects submitted by other users, thus helping to make medical products safer for everyone.

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 Posted on December 06, 2013 in Illinois Defective Medical Products Lawyer

USA Today published a stunning report that reveals that, across the country, there are thousands of doctors who are forbidden to practice in hospitals or other medical establishments, yet have not received any kind of punishment from state medical boards. Those doctors, despite having settled multiple medical malpractice suits, still maintain their medical license.

The publication collected data and statistics from multiple sources, including the National Practitioner Data Bank. The law mandates that any “adverse action” filed against a physician must be reported to the data bank – the intention being that the data bank would be closely watched by the state boards. Other sources of information were hospital disciplinary records and malpractice payment records.

The investigation revealed that almost 6,000 physicians had clinical privileges revoked between the years 2001 and 2011. But astonishingly, more than half of these same doctors never received any kind of discipline or reprimand from their state licensing boards. No fines, restrictions, suspensions or revocations were issued against these doctors.

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 Posted on November 29, 2013 in Defective Medical Devices

The FDA announced recently that federal health regulators will be able to track millions of medical devices around the country soon with a new electronic system. The goal of the program, which works with pacemakers, hip replacements, and a broad array of medical devices, is to protect patients by identifying problems early on. Serious problems from defective medical devices have led to complications, follow-up surgeries, and attorneys tackling the issue head-on.

The new rules required that the majority of medical devices sold within the U.S. be connected with a unique code including the make, lot number, and manufacture date. The database of the information collected from these devices will be stored publicly to allow consumers, physicians, and companies to monitor whether any safety issues present a concern.

The concept of the tracking system is not new; those concerned with the growing number of painful and complicated issues reported by victims of defective medical devices have been calling for its use for several years. Doctors will now also be able to use the codes in the medical records belonging to their patients, developing an electronic trail of information that will flag defective devices earlier.

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 Posted on November 25, 2013 in FDA

Johnson & Johnson has agreed to pay $2.2 billion to settle charges with the U.S. Department of Justice over the alleged illegal marketing of Risperdal, Invega and Natrecor. Johnson & Johnson has been accused of improperly promoting the antipsychotic drug Risperdal for the elderly, children, and people with developmental disabilities. The Food and Drug Administration had only approved the drug for limited pediatric uses in 2006. Further, According to the Department of Justice, Johnson & Johnson paid kickbacks to physicians and to Omnicare Inc., a pharmacy that provides certain medications for nursing homes. The settlement is the third-largest in United States history for pharmaceutical cases, and the is only the latest in a succession of lawsuits involving the marketing of anti-seizure and antipsychotic medications as a way to control patients with dementia and children with developmental disabilities, notwithstanding substantial health risks with the drugs.

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 Posted on November 22, 2013 in Defective Medical Devices

The Food and Drug Administration recently announced a new regulatory requirement for medical devices. All devices must now have a unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The development and safe operation of medical technology is literally of life and death importance, and manufacturers must uphold high standards in both quality and safety. The FDA UDI system will allow manufacturers to identify their products with a unique number.

The Unique Device Identification system will have a 14-digit number, which must be displayed conspicuously on device labeling and packaging. Further, attributes of each device associated with a particular UDI number must be submitted and stored in the FDA' Global Unique Device Identifier Database.

These regulations have a major impact on safety because they remove the necessity of renumbering old medical devices in the field. It also reduces the chances that a consumer of the product is using a counterfeit because the identity of all of the products will be known in the FDA's database. Finally, it enhances communication between manufacturers, hospitals, doctors and distributors. With improved communication, malfunctions or negative events caused by devices can be reported from end-users to manufacturers. Communication, of course, will more effectively flow the other way as well, and product recalls from manufacturers to patients can occur on a timelier basis.

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