Archive for the 'Defective Medical Devices' Category

Regulators were warned for four years on defective PIP breast implants

Filed May 23rd, 2012 Joshua

Health regulators in the United Kingdom were aware of problems with defective PIP silicone breast implants for at least four years before they were eventually recalled from the market in Europe and some parts of South America.
More than 50,00 women in the U.K., and tens of thousands more around the world received the less expensive [...]

Blood Clot Risk Higher with NuvaRing, Other Non-Oral Hormonal Contraceptives

Filed May 15th, 2012 tmccoy

by: Stephanie Herschaft, Esq.
According to a new Danish study published in the British Medical Journal (BMJ), women who use non-oral hormonal contraceptives such as patches and vaginal rings, including NuvaRing may be at higher risk of blood clots than those who take oral forms of hormonal birth control.
The study was done by researchers from the [...]

Startling Statistics on Medical Device Recalls

Filed May 15th, 2012 tmccoy

by: Michael Werner, Esq.
The Wall Street Journal recently released startling new statistics regarding the prevalence of medical device recalls.
During the first quarter of 2012, medical device recalls rose more than 160%, affecting more than five times as many units than the previous quarter. According to the U.S. Food and Drug Administration (“FDA”) Enforcement Reports, [...]

Patients with Faulty Heart Devices Facing Risky Decision

Filed May 14th, 2012 tmccoy

by: Michael Werner, Esq.
In St. Jude Riata Defibrillator Unit Significantly Worse Than Medtronic’s Quattro I discussed the growing evidence of St. Jude Medical, Inc.’s (“SJM”) Riata defibrillator lead failure. Michael Minton of Joelton, Tennessee is one of 79,000 U.S. patients who currently have the Riata defibrillator implanted in their chest.
After viewing [...]

Louisiana woman claims InFUSE led to permanent disability

Filed May 13th, 2012 Joshua

A Louisiana woman has become the latest to claim she’s the victim of side effects of the bone growth product InFUSE when it was used on her in an “off-label” treatment.
Crystal Stevens, according to a report from The (Louisville, Ky.) Courier-Journal, claims she is permanently disabled and must rely upon her husband (named as a [...]

Additional Warnings on Non-FDA Approved MS Treatment

Filed May 11th, 2012 tmccoy

by: Michael Werner, Esq.
In yesterday’s blog titled FDA Warns MS Patients About Experimental Treatment After Reports of Paralysis, Fatalities we introduced the U.S. Food and Drug Administration’s (FDA) recent concern regarding experimental and unconfirmed treatments for chronic cerebrospinal venous insufficiency (CCSVI). Additional information has been released by the FDA in connection with this advisory. [...]

St. Jude Riata Defibrillator Unit Significantly Worse Than Medtronic’s Quattro

Filed May 11th, 2012 tmccoy

by: Michael Werner, Esq.
Although St. Jude Medical, Inc. (“SJM”) recalled its Riata defibrillator leads last year because of faulty silicone covering of the unit’s metal wiring, approximately 79,000 U.S. patients still have the Riata defibrillator unit implanted. Frighteningly, a multicenter study released last Thursday concluded that the Riata defibrillator leads performed “significantly worse” [...]

Canadian Doctors, Patients Cautioned About Metal-on Metal Hip Troubles

Filed May 10th, 2012 tmccoy

Health Canada, the agency charged with regulating medical products in Canada, has issued advice on managing patients with metal-on-metal hip implants. In addition, the department is alerting patients of the trouble signs associated with their metal-on-metal hip implant.
The Health Canada statement was issued as the reports of problems with the metal-on-metal hip implant continue to [...]

FDA Warns MS Patients About Experimental Treatment After Reports of Paralysis, Fatalities

Filed May 10th, 2012 tmccoy

The FDA is warning MS Patients about the dangers of an experimental treatment that props open internal veins in the neck and chest, because it can cause death or serious injury.
According to the FDA, at least 2 people died from the procedure, which uses stents or balloon angioplasties to widen veins that connect the brain [...]

FDA suggests child-size radiation doses for CT scans, limit X-rays

Filed May 9th, 2012 Joshua

The Food and Drug Administration is taking active steps to ensure that children aren’t over-exposed to radiation during routine medical imaging scans, like CT scans and X-rays.
According to a Fox News and AP report this week, the agency is unveiling guidelines for dispensing child-size doses of radiation to be used in conjunction with common medical [...]

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