The Vibrational Integrated Bio-photonic Energizer (VIBE device) and the Nebion HLX8 device – both unapproved medical devices – are subject to a Class I Recall. A Class I recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.  According to the FDA, the manufactures of  both devices claimed they treated conditions ranging from cancer to migraines. The agency  is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

According to the FDA, Nebion LLC of Los Angeles, Calif. recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval, the FDA said.  The recall followed a June 2008 FDA inspection of the company which revealed that Nebion had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation. (more…)

Banks, charities and ordinary investors stand to lose billions because of the investment fraud allegedly committed by Bernard Madoff.  The Wall Street Journal reported today that the Securities Investor Protection Corp., a nonprofit funded by the securities industry to aid investors affected by failed firms, could start the process of liquidating the Madoff brokerage firm. SIPC covers some losses up to $500,000 per customer in limited cases, but it is unclear the extent to which SIPC will cover the investment adviser accounts, the Journal said.

According to media reports, the Madoff securities fraud has impacted a lot of wealthy investors.  They reportedly include Philadelphia Eagles owner Norman Braman, New York Mets owner Fred Wilpon and J. Ezra Merkin, the chairman of GMAC Financial Services, among others, the Associated Press said. (more…)

The U.S. Food and Drug Administration (FDA) just announced it is adding a Boxed Warning to the labeling of prescription oral bowel prep products, and warned about possible kidney problems with over-the-counter versions as well.  Meanwhile, C.B. Fleet Company has announced a voluntary recall of its OTC  Fleet(R) Phospho-soda products.

In 2006, the FDA issued a “Science Paper and a Healthcare Professional” sheet describing the risks associated with the use of oral sodium phosphate OSP products for bowel cleansing. OSPs are generally taken by patients for bowel cleansing prior to certain medical procedures such as colonoscopy. As part of the FDA’s post-marketing surveillance, it has received 20 reports of kidney injury linked to OsmoPrep; three were biopsy-proven cases of acute phosphate nephropathy.  The onset of kidney injury varied, with some occurring within several hours and others within 21 days after using the OSP. (more…)

Advanced Medical Optics (AMO) has issued another recall of a contaminated product.  This time, the company is recalling its Healon D Ophthalmic Viscosurgical Device (OVD) after testing revealed endotoxin levels that were too high.

This is not the first time an AMO product has been recalled for contamination problems.  Between 2006 and 2007, AMO issued two such recalls some of its Complete MoisturePlus products.  In some cases, these recalled products caused serious eye infections, leading to permanent injury for some victims. (more…)

The diabetes drugs Avandia and Actos have been linked to another serious side effects – bone fractures in women. According to a new study, women who take one of the drugs for just a year face double the normal risk of bone fractures.  While bone fractures are a known risk of Avandia and Actos, this study, conducted by researchers in the U.S. and Britain, is the first to quantify that risk.

This new study is likely to raise more concerns over the safety of Avandia and Actos, which are associated with other serious side effects. The labels of both drugs carry strong warnings about their link to heart failure.  In May 2007,  an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking Avandia had a 43-percent higher risk of having a heart attack. In November 2007,  the Food & Drug Administration (FDA) finally ordered that a black box warning detailing Avandia’s heart related risk be added to the drug’s labeling. (more…)

Already dealing with the affects of a decades-old oil spill, residents in Greenpoint Brooklyn must now worry about toxic gases  leaking into their homes.

According to the New York Times, the New York State Department of Environmental Conservation has been testing homes throughout  the state to gauge whether vapor intrusions from contaminated soil and groundwater is a serious public health problem. Greenpoint, once a hub for refineries, petroleum storage facilities, dry cleaning plants and other manufacturing facilities, is one of the neighborhoods officials are focusing on. (more…)

Defective Tenderflow Pediatric Arterial Cannulae are being recalled by Terumo Cardiovascular Systems.  An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

According to the recall notice, when the  introducer  cannot be retracted from the Tenderflow Pediatric Arterial Cannulae, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.  According to the Food & Drug Administration (FDA), the recall was issued after Terumo received five reports of difficulty retracting the introducer from the cannula. There there have been no reports of patient injury or death associated with the defective Tenderflow Pediatric Arterial Cannulae. (more…)

Last week, the Judicial Panel on Multidistrict Litigation consolidated all federal lawsuits involving the  The Mentor ObTape Vaginal Sling in a Multidistrict Litigation in the U.S. District Court for the Middle District of Georgia. The cases will be assigned to U.S. District Judge Clay D. Land.

The Mentor ObTape Vaginal Sling has been named in at least 22 personal injury lawsuits that were pending in various federal courts. In October, Mentor Corp. had asked the panel to transfer the ObTape lawsuits to either the Western District of Oklahoma, the Northern District of Oklahoma or Northern District of Ohio.  However, plaintiffs’ attorneys, who opposed the consolidation, requested the lawsuits be assigned to the Middle District of Georgia, where 5 cases – the most in any single federal court – are pending. (more…)

Allegations that Edwards LifeSciences’ experimental Myxo ETlogix 5100 Ring device was implanted in a patient without her consent has sparked a Congressional probe.

Antonitsa Vlahoulis, who received the device in 2006,  told the Chicago Tribune that she would have never consented to receiving an experimental implant.  She claims officials from Northwestern Memorial Hospital and Edwards told her the device was not experimental because it was a modified version of one of the company’s other repair rings, which are approved by theFood & Drug Administration (FDA).  Vlahoulis later had the Myxo Ring removed because of inflammation, and now needs a heart transplant. (more…)

A new Trasylol (aprotinin) study concludes that less expensive medications are safer than the now-withdrawn Bayer drug.

To reach that conclusion, researchers at the Institute for Clinical Evaluative Sciences (ICES) in Toronto reviewed 49 randomized trials comparing Trasylol to one of two lysine analogues, tranexamic acid or aminocaproic acid.  (more…)