bad medical devices blog

A Bloomington, Ind., woman says the NuvaRing birth control product nearly took her life after she switched off “the pill”.
WMBD and WYZZ report 26-year old Liz Larson says she developed “a few clots” in each of her lungs while on NuvaRing for only two months. For the previous 10 years, Larson relied solely on the […]

Artificial blood is too risky for further testing, because patients who receive it have a 30 percent increased chance of dying, investigators working at the National Institutes of Health have concluded. Researchers there raise serious questions about the FDA’s role in continuing to allow human trials of these products, despite evidence from past clinical trials […]

Brooklyn’s BioMedical Tissue Services body parts scandal ringleader Michael Mastromarino, who has pleaded guilty to hijacking diseased corpses from funeral homes and fraudulently selling the parts, tried to make a deal earlier this month in Philadelphia so keep his sentence down to the 18-54 years he’d be getting in Brooklyn. But — not surprisingly — […]

Medtronic and the Food and Drug Administration have an agreement over the company’s quality control issues at a subsidiary facility making external heart defibrillators.
FDA inspections at Physio-Control Inc., a wholly-owned subsidiary of Medtronic, revealed questionable practices of the company’s “quality system processes” in the manufacture of external defibrillators and regulators outlined actions Physio-Control could take […]

So many doctors are quick to refer patients in for an MRI (Magnetic Resonance Imaging scan) without realizing that the procedure may actually cause Nephrogenic Systemic Fibrosis (NSF) in kidney patients.
Nephrogenic Systemic Fibrosis (NSF) is an often quickly debilitating condition. The first symptoms are usually hardening or thickening of the skin, usually on the arms […]

The Supreme Court ruling which seemingly gives medical device makers immunity from lawsuits is not stopping injured patients from pressing forward.
The family of an Orange, Texas man is suing Boston Scientific after its Implantable Cardioverter Defibrillator failed Joseph Roberts when he arrived at a
Texas hospital for an upgrade to a Vitality 2 biventricular ICD in […]

There is a disturbing report on the prospect of kid-friendly medical devices.
Currently most medical devices are made for adults, and sized accordingly. But often times children could be the needy recipient of a medical device. Doctors are trying to work around the limitations of medical devices too big, but that statement alone carries a risk.
That […]

According to a letter released Tuesday, the FDA has warned medical device maker Philips Medical Systems Inc about a long list of manufacturing procedures at the company’s Cleveland Ohio plant, including a failure to properly oversee medical device design.
The FDA’s inspections of the plant, which makes computed tomography (CT) and nuclear medicine devices, in September […]

The Food and Drug Administration (FDA) will soon be faced with a difficult decision regarding drug-eluting stents.
After the first year of a clinical trial on Abbot Vascular’s Xience stent, it outperformed the most popular such device, the Taxus. The Xience used a new kind of drug coating, according to an article at WebMD.com, and seems […]

A recent study suggests surgeons will opt more for alternative acetabular bearing surfaces in future hip implant surgeries.
In the next two years, according to Millenium Research Group, 45 percent of physicians plan to use a ceramic component in joint replacement surgeries. Another 30 percent say they will use metal acetabular bearing surfaces in hip surgery.
Debris […]