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Medical Device Warnings

Medical Device - Lawsuit Information

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There is little doubt that innovations in medical research can benefit society. But the desire to find new ways to treat illness must be balanced with public safety. Unfortunately, the rush to get a product on the market as soon as possible sometimes comes at the expense of safety.

A defective medical device lawsuit not only can claim financial compensation for your family’s medical expenses, lost wages and pain and suffering, but also can contribute to getting defective devices recalled or removed from the American market. Thus, potential future victims may be spared with help from your defective device lawsuit.

For a full list of current FDA warning letters please read the 2013 Warning Letters. view notices

Many medical device companies are content to keep selling defective drugs and defective medical devices even though they’re known to harbor dangers. The reason why is simple, because it means they can continue to reap billions of dollars in profits. We are currently tracking some of the most dangerous devices on the market and work hard to keep this list updated on a regular basis.

Mirena IUD - is a plastic intrauterine contraceptive device (IUD)

In 2009, The FDA issued two warning letters to Bayer Pharmaceuticals stating that the manufacturer “presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”

Statistics from the FDA indicate that Mirena complications, including incidents of device migration, have been cited in thousands of adverse event reports made to the agency

(read more)

Transvaginal Mesh - used for common female pelvic issues

Both Stress Urinary Incontinence and Pelvic Organ Prolapse were initially thought to be corrected by the implantation of a small, synthetic mesh-like device within a woman’s vaginal cavity. The TVMs were typically made from polypropylene or polyester and designed to act as a support for sagging pelvic organs in women who’d experienced hysterectomies, complications from births, and/or menopause.

The FDA issued a vaginal mesh injuries warning in 2011, alerting the public that transvaginal mesh complications are more common than manufacturers had previously disclosed and that, in some cases, implantation of vaginal mesh devices was no more effective than traditional surgeries.

(read more)

Nuvaring - once-a-month contraceptive

A small plastic ring that is inserted into the vagina and remains there for a three week period. NuvaRing works by releasing hormones that prevent pregnancy. Research suggests the type of hormone released by NuvaRing (desogestral) is especially dangerous to the women who use it.

More than a dozen studies conducted over more than a decade have shown that women taking contraceptives containing a third-generation progestin—such as that used in NuvaRing and some birth control pills—have a 1.4 to 4 times higher risk of developing blood clots than women on contraceptives containing second-generation progestin.

(read more)

Stryker Hip - all-metal hip replacement

The Food and Drug Administration (FDA) has sent a warning letter to Stryker Corporation related to quality concerns at one of its facilities. The agency’s letter also warned the orthopedic implant company that it had been marketing devices without approval and failed to notify the FDA of a product recall.

Stryker is currently facing hip replacement lawsuits alleging that its Rejuvenate hip replacements and ABGII hip replacements fail at a high rate.

(read more)

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