Posted on January 19,2014 in Defective Medical Devices

An intrauterine device (IUD) is a commonly preferred method of birth control used by many women, suggested for use in women who have had at least one child. According to WebMD, “an IUD is a small, T-shaped plastic device that is wrapped in copper or contains hormones.” It is implanted into the uterus by a medical professional, and stays in place, releasing hormones on a schedule for up to five years. Mirena is a popular hormonal IUD that “releases levonorgestrel, which is a form of the hormone progestin.” It is expected to be quite an effective method of birth control—according to WebMD, it “prevents fertilization by damaging or killing sperm.”

About one year ago, however, it was announced that the side effects of Mirena were severe enough to issue widespread warnings about its use. According to the Adverse Events Report and as reported by PRWeb.com, “the FDA has disclosed receiving over 45,000 AERS reports of women suffering complications while using the Mirena IUD.” The severe side effects reported by Mirena users included “device expulsion, device dislocation, and vaginal hemorrhage. In more than 6 percent of cases, patients required hospitalization or surgery,” PRWeb.com reports.

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 Posted on January 14,2014 in Dietary Supplements

In late December, a previously healthy 28-year-old man from North Carolina experienced liver failure that required a transplant after several weeks of using a dietary supplement called Mass Destruction. According to their website, the “U.S. Food and Drug Administration is advising consumers to immediately stop using” this product, “marketed as a dietary supplement for muscle growth.” The supplement, which contains at least one synthetic anabolic steroid, has been linked to the liver failure of the North Carolina man. “Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances,” according to the FDA. The product's ingredients are “undergoing further analysis” by the agency.

The supplement is sold in stores, gyms, and online, but it was not immediately apparent who the manufacturer of Mass Destruction was, according to the FDA. It is manufactured for Blunt Force Nutrition, a distributor based in Sims, North Carolina. According to the FDA, “consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional.” Possible symptoms of liver failure and other health risks posed by such supplements can include fatigue, discolored urine, and abdominal or back pain.

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 Posted on January 11,2014 in Defective Medical Devices

Medtronic Inc. devised a bone graft device known as Infuse Bone Graft, which hit the market in 2011. As of mid-2013, the Infuse had been used in millions of surgeries across the nation, touted as a safer alternative to a bone graft after spinal surgery. According to Bloomberg News, however, the Infuse “works no better than a graft and carries side effects including an increased risk of cancer, two independent reviews found.” These studies were originally published in the Annals of Internal Medicine, Bloomberg reports, and were commissioned by Medtronic Inc. “after the product's risk-benefit profile was called to question by research linking it to male sterility, infections, and cancer,” Bloomberg News reports.

In mid-2013, shares for Medtronic, “the world's biggest maker of spinal treatments,” fell 1.1 percent after having gained 39 percent since 2012, reports Bloomberg. Part of the controversy stemmed from the fact that, according to Medscape, “several harmful side effects of using [Infuse] in spinal fusion surgery went unreported in the published articles supporting the safety and efficacy of that product.” Data presented by Medtronic as to the safety of Infuse were at complete odds with data compiled from similar studies by the FDA. According to Medscape, “the FDA data show there was increased radiculitis, an increased number of leg pain events, increased infection rates, and an increased chance of sterility.”

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 Posted on January 08,2014 in Defective Medical Devices

In an attempt to settle thousands of defective medical device lawsuits over its recalled hip implants, Johnson & Johnson subsidiary DePuy has agreed to pay at least $2.47 billion. Patients have told a judge while outlining an accord, however, that the final settlement may be worth more than $4 billion total.

The global health care company recalled 93,000 defective ASR hip implants in 2010. Doctors and patients began complaining that the implants are weak and internal company documents have shown that 37 percent of the implants fail within 5 years.

The ASR implants were approved for sale in 2005 and consisted of a new metal-on-metal design that DePuy advertised would last 20 years and offer a wider range of motion than traditional hip implants. When they fail, however, the implants could cause dislocations, and debris from the device can get stuck in the soft tissue surrounding the joint as well as the muscles and ligaments.

This is the second large judgment against Johnson & Johnson and its subsidiaries in the past month. The company was recently ordered to pay $2.2 billion by the United States Justice Department in order to settle criminal and civil claims that the company marketed the prescription medication Risperdal to patients it was not approved to treat. The company has also been accused of paying doctors and pharmacists kickbacks for additional prescriptions.

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 Posted on January 03,2014 in Defective Medical Devices

The United States Food and Drug Administration (FDA) has announced that two chemicals that are used in heart stress tests can cause heart attacks and can also cause death. The chemicals, Adenoscan and Lexiscan, are both manufactured by Astellas Pharma US Inc.

Heart stress tests are performed on patients who are unable to exercise. When conducting a test, physicians inject the patient with the chemicals. These chemicals actually cause the heart to stress, allowing pictures of the heart to be taken to see where low blood flow is occurring and if there is any area of damage to the organ.

Adenoscan and Lexiscan actually dilate the arteries in the heart. This dilating causes the increase in the blood flow and this is how obstructions in the arteries are found during the test. But as the blood flow is increasing in the unblocked arteries, it is actually decreasing in the blocked ones and the FDA says this is what can cause a heart attack.

As part of its warning, the FDA said resuscitation equipment should be on site when testing is being done to a patient, as well as fully trained staff.

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 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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