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Archive for the ‘Medical Device’ Category

The Essure Procedure and How It Can Affect Your Body

According to Bayer, manufacturer of the device, the Essure procedure is the only permanent birth control available that does not require surgery. The device does not release hormones and the company says it is 99 percent effective at preventing pregnancy. However, recent studies have uncovered safety concerns with the device. What is the Essure Procedure?

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Could A Forced Air Surgical Warming Blanket Have Caused My Surgical Infection?

Surgical Warming blankets have been used in operating rooms for quite some time in order to maintain a patient’s temperature during surgery. This is especially true after orthopedic surgery, including hip replacement, as the use of warming blankets decreased blood loss in patients undergoing the surgery and were thought to reduce the risk of surgical infection.

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What is Mass Tort Litigation?

Many people have heard of class action lawsuits, but few are familiar with mass tort litigation. Although mass tort litigation is similar to class action lawsuits in that there are multiple cases combined into one, there are some differences. A class action lawsuit is a type of mass tort litigation. In order to reduce the

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Mass Tort Attorneys Report: The Pelvic Mesh Litigation Continues, With Several Plaintiff Wins

Pelvic mesh is commonly used in pelvic surgeries after pelvic organ prolapse (POP), or when muscles in the pelvic region weaken, causing organs to bulge or slip into the vagina. Pelvic organ prolapse can happen due to age, childbirth, or other reasons and is associated with pain along with bladder leakage. Countless women receive this

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Questions raised on whether medical device industry embraced safety reforms

April 19, 2012 The New York Times (4/19, B1, Meier, Thomas, Subscription Publication) reports, “As doctors scramble to understand the risks posed by a flawed heart device component made by St. Jude Medical, the episode is raising a bigger question — whether the $10 billion heart device industry has fully embraced promised safety reforms.” In

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Abbott Laboratories recalls up to 359 million glucose testing strips

The AP (12/22) reported, “The Food and Drug Administration says Abbott Laboratories is recalling up to 359 million testing strips used by diabetics because they can give falsely low blood sugar readings.” Because of the false results, “patients may try to raise their blood sugar levels unnecessarily or fail to detect dangerously high blood sugar levels.”

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FDA issues warning about Cardiac Science defibrillators

NBC Nightly News (4/27, story 11, 0:20, Williams) reported, “According to the FDA, defibrillators made by the Cardiac Science Corporation and sold under the label Power Heart could fail because of faulty software contained inside.”The Seattle Times (4/27) reported, “The Food and Drug Administration on Tuesday issued an unusual public warning about 280,000 external defibrillators

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FDA to institute stricter oversight of home medical devices

Bloomberg News (4/21, Olmos, Larkin) reports, “US regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety of the increasingly popular products, according to information posted” on the FDA’s website. Notably, the “initiative will set new guidelines for home medical device manufacturers, training programs for patients

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FDA to reevaluate ReGen knee repair device

The AP (3/19, Perrone) reported that ReGen Biologics, the medical device maker “at the center of a highly controversial Food and Drug Administration approval, is pushing back against the agency’s plan to reevaluate” its Menaflex knee repair implant. The company’s “implant spent more than three contentious years under review at the FDA before gaining approval

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Families push for medical device bill

August 17, 2009 The Star Tribune reports that several families are pushing for Congress to pass a bill called the Medical Device Safety Act, which would restore the right for some patients to sue manufacturers for a malfunctioning device. Read More

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