BMP protein, a bone growth agent used in products like Medtronic Inc.’s Infuse Bone Graft, may be responsible for serious complications when used to treat neck pain, and may not be cost effective, according to a new study. The study, conducted by researchers at Brigham and Women’s Hospital in Boston, found that when used in the neck region of the spine, some complications from BMP products like Infuse could be life-threatening.

BMP products have become very popular since they were first introduced. According to the Associated Press, some small studies have shown that these products allow better healing of the bone and fewer repeat surgeries to fix failed spinal fusions. The product also makes it unnecessary to surgically harvest the patient’s own bone from the shin or hip for a graft. (more…)

Medtronic Inc. has received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the Food & Administration (FDA), cites Medtronic for taking too long to recall the SynchroMed pumps. The letter also said that an inspection conducted last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing.

SynchroMed II pumps are implantable devices used to deliver medicine to the spine. They have been recalled on several occasions. (more…)

Experts told lawmakers that the U.S. Food and Drug Administration’s (FDA) process for medical device approval needs strengthening to adequately protect consumers from safety risks, reported Reuters, which noted that a medical device can be anything from “tongue depressors to artificial hips.”

According to Representative Frank Pallone (democrat)—chair of a House Energy and Commerce subcommittee—who said he was trying to determine if there were issues that need correction via new legislation or increased FDA oversight, “There is evidence of an approval system that is broken—that its standards, its procedures, and its rules don’t meet modern needs of getting medical devices to those in need with confidence in their safety,” quoted Reuters. Marcia Crosse—healthcare director for the nonpartisan Government Accountability Office (GAO)—said that the issues “raise concerns … that are necessary for ensuring the safety and effectiveness of medical devices,” referring to the agency’s process for pre-approval reviews and post-approval monitoring, said Reuters. (more…)

Medtronic Inc. has confirmed that it paid hundreds of thousands of dollars to an ex-Army surgeon who is accused of falsifying data in a study he conducted on the company’s Infuse Bone Graft product. According to the Associated Press, Medtronic paid the surgeon - Dr. Timothy Kuklo - $850,000 over a 10 year period.

Kuklo retired from the Army in 2007. According to the Associated Press, Medtronic made both indirect and direct payments to Kuklo between 2001 and May 2009. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company. (more…)

Medical device maker Synthes Inc. and its Norian subsidiary have been indicted on charges of illegally testing Norian XR bone cement on humans. According to Bloomberg.com, those trials - some of which were conducted at VA hospitals - allegedly resulted in the deaths of three patients from severe low blood pressure following surgery with Norian XR.

According to The Wall Street Journal, the U.S. Justice Department has been investigating Synthes and Norian for illegal off-label promotion of the XR product since 2006. That year, the company was served with a grand-jury subpoena. (more…)

Medtronic Inc. is issuing a Class I recall for certain Medtronic Kappa and Sigma pacemakers because of wiring issues that may cause the devices to fail. A Class I recall is the Food & Drug Administration’s (FDA) most serious recall action, and is issued when there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.

The Medtronic pacemakers involved in this recall include:

Kappa Series 600/700/900
Sigma Series 100/200/300 (more…)

Federal regulators missed several opportunities to keep tainted pre-filled syringes from the AM2PAT facility in North Carolina from endangering patients, according to a new investigation by The Chicago Tribune and ProPublica. The bacteria-laden AM2PAT prefilled syringes were linked to scores of serious and sometimes deadly illnesses in 2007 before they were finally recalled.

The Tribune/ProPublica investigation found several instances where the Food & Drug Administration (FDA) failed to follow-up on possible problems at AM2PAT. In March 2005, a pharmacist reported large amounts of orange sediment floating in an AM2PAT syringe, as well as an inch-long black hair suspended in another. An inspector visited the facility in June, the report said, and noted nine “significant violations”, and AM2PAT was issued an FDA warning letter. But following a January 2006 inspection, the FDA determined that AM2PAT had fixed the problems cited the previous June. (more…)

The relationships and finances exchanged between Industry and researchers have long been making the news and point to a bias in which patients are often not the prime concern. In a growing trend of reports of physicians and researchers failing to disclose Industry payments, the Wall Street Journal just released an article about prominent spine surgeon Jeffrey Wang who has joined the ranks of these physicians.

Wang, chief of spine surgery from the University of California, Los Angeles (UCLA) neglected to disclose payments from medical companies while conducting research for them, said the Journal, citing records obtained by congressional investigators. UCLA’s Jeffrey Wang, kept quiet about $459,500 he received from 2004 through 2007, said the Journal, according to a May 21 letter it reviewed from Senator Charles Grassley (Republican-Iowa) to UCLA’s chancellor. According to Grassley, said the Journal, Dr. Wang “consistently checked no” on the forms in the area asking if income exceeding $500 was received from companies funding Wang’s clinical research. (more…)

Senator Charles Grassley (R-Iowa) is seeking an explanation from Medtronic Inc. for its failure to list Dr. Timothy Kuklo as a paid consultant when it submitted a list of such physicians to him in October. As we’ve reported previously, Kuklo is the former Walter Reed Army Hospital surgeon who conducted a study on Medtronic’s Infuse Bone Graft product that apparently contained falsified data.

According to The New York Times, which originally broke the Kuklo story, Grassley has been investigating Infuse for some time over claims that Medtronic illegally promoted its off-label use. Some have charged that the company paid doctor consultants to hype such uses. According to The Wall Street Journal, Medtronic had submitted a list of 22 consultants to the Senator in October, but Kuklo’s name wasn’t on that list. Grassley has now written a letter to Medtronic asking why. (more…)

Cannondale Bicycle Corporation of Bethel, Connecticut; Trek Bicycle Corporation of Waterloo, Wisconsin; and Norco Performance Bikes, of British Columbia, Canada have all issued bicycle recalls over crash hazards, the U.S. Consumer Product Safety Commission (CPSC) announced today.

Cannondale Bicycles
Importer Cannondale Bicycle Corporation recalled about 1,500 Bicycles with JD Suspension Forks because the JD forks, which were manufactured in Taiwan, can lose alignment, causing the front wheel to turn unexpectedly and the rider to lose control of the bicycle and crash. JD Components manufactured Cannondale Bicycles. The recall involves model year 2008 Cannondale Adventure 2, Adventure 3, Adventure 2 Feminine, and Adventure 3 Feminine bicycles. The model name is printed on the bicycle’s frame and the bicycles’ suspension fork is imprinted with the words “cannondale AT35 adventure trail.” (more…)