Canadian hip implant lawsuits are on the rise, with patients alleging that their devices break down and leave them in pain. No less than four class action lawsuits are underway against different hip implant device makers.

Some of the lawsuits involve patients whose symptoms worsened after undergoing joint replacement surgery, said CBC News. In one case, not only did symptoms become worse, the corrective surgery left at least one patient with reduced quality of life. CBC News talked to Rob Desborough of Pictou, Nova Scotia, who said that one day, while gardening, his implant fell apart and the revision surgery—to remove and replace the defective device—was “difficult.” (more…)

Stent procedures have been linked to high readmission rates with about one out of every six patients readmitted to the hospital within one month of their original procedure.

Stents are tiny wire-mesh tubes used during heart surgery that prop arteries open after angioplasty, in which blockages are cleared. Some stents are manufactured with a drug coating meant to keep blood vessels from re-clogging. (more…)

A new hip and knee implant study is raising questions about newer model devices that might not perform any better than older generation designs that cost less. As a matter-of-fact, the older, cheaper models might actually last longer. A big consideration given that when a hip or knee implant fails or needs replacing, surgery is required.

The New York Times said that the newly published study reviewed information from Australia’s orthopedic registry and looked at implants that were introduced to the market 2003 – 2007. Metal-on-metal implants are constructed with both a metal ball and metal cup, said The Times, and were intended to be longer lasting than their predecessors. Unfortunately, the newer generation implants are expected to fail earlier, with replacements needed much sooner than the older implants, which generally last for about 15 years, The Times pointed out. (more…)

In the midst of probes, shareholder lawsuits, and broad criticism concerning its Infuse bone growth product, Medtronic is making headlines again. This time, three senators are asking for information on Medtronic’s Infuse product.

Senators Charles Grassley (Republican-Iowa), Herb Kohl (Democrat-Wisconsin), and Richard Blumenthal (Democrat-Connecticut) asked, in a letter described by The Star Tribune as having an “investigational tone,” for very specific information on how Medtronic monitors its products once they are released and for information on Infuse. (more…)

A Class I recall, the U.S. Food & Drug Administration’s (FDA) most serious designation, has been issued for St. Jude Medical Inc.’s Riata leads. The recall involves the performance of Riata® and Riata® ST Silicone Defibrillation Leads. The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.

Last year, St. Jude sent a letter to physicians explaining that the devices’ cables with newer coating experienced less problems and have almost replaced older versions (the phase-out is expected to be completed by year end); At the time the letter was sent, an FDA spokeswoman said that the issue did not warrant a recall. (more…)

A Medtronic Infuse shareholder lawsuit was just granted class action status by a Minnesota federal judge. The shareholder group alleges that Medtronic Inc.’s stock value dropped over Medtronic’s off-label promoting of its Infuse spinal graft product.

Cleared by the U.S. Food & Drug Administration (FDA), in 2002, Medtronic Infuse is a bone growth product approved for use in one type of spine surgery (anterior approach lumbar fusion), Infuse was ultimately approved for two different types of dental surgery. (more…)

Emerging research reveals that newer hip implants offer no significant benefits over older devices. As a matter-of-fact, studies are finding that older versions might be safer and more long lasting than some newer versions; this according to a study funded by the U.S. Food & Drug Administration (FDA).

This early research is among the first to look at different outcomes for various artificial hip devices constructed with different materials, said WebMD. Researchers reviewed data on total hip replacements from different studies and national registries and concluded that no advantages exist in the newer metal-on-metal or ceramic-on-ceramic devices, versus traditional metal-on-polyethylene or ceramic-on-polyethylene devices and that traditional devices work as well and, sometimes, even longer, as the newer generation, more expensive implants, noted WebMD. (more…)

Yale University researcher and cardiologist, Dr. Harlan Krumholz, has been tapped to review medical device giant, Medtronic’s, Infuse bone growth product controversy.

According to Forbes magazine, Dr. Krumholz is “the most powerful doctor you never heard of,” said The Star Tribune. Dr. Krumholz reviews how the ill are treated and analyzes results to suggest better, sometimes more efficacious and inexpensive, treatments, a method he calls “outcomes research.” (more…)

CareFusion has issued its second recall for ventilators, saying this is an urgent recall that involves problems that could lead to serious injury or death. According to CareFusion, it has recalled 29 of its EnVe ventilators over problems that could lead to delayed starts or shut down.

The recalled machines were manufactured between December 2010 and May 2011, said SignOn San Diego, noting that the U.S. Food and Drug Administration (FDA) assigned its most serious designation—Class I—to this recall. The FDA describes Class I recalls as involving situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. (more…)

House Energy & Commerce Committee Democrats are asking Republican lawmakers to probe metal hip implant and brain stent safety and regulation. In a letter authored by Democratic representatives Henry Waxman (California), Frank Pallone (New Jersey), Diana DeGette (Colorado), and John Dingell (Michigan) the Republican chairs of three key House committees were targeted.

“We believe that looking further into the ‘metal-on-metal’ hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices,” said the representatives in their letter dated October 12, said Mass Device. Mass Device noted that hip replacement surgery is among the most popular surgery in the United States, with over 500,000 performed, to date, according to the letter. (more…)