Medtronic’s headline-making Infuse bone graft product is facing a hazy future. Amid an independent investigation and suppression of evidence, Medtronic Inc. has seen a significant drop in sales.

According to a report from Newsinferno, Medtronic aggressively attempted to contain proof that Infuse (rhBMP-2)—specifically when used in unapproved medical procedures—is the culprit in numerous health issues, including cancer. It seems that prior to its approval in 2002, Medtronic paid surgeons very generously to provide research pointing to the product’s safety and, when research indicated that Infuse was linked to complications, Medtronic suppressed that research. (more…)

Warnings have been issued in the United Kingdom over metal-on-metal hip implant devices. The move followed an investigation there and adds to the growing concern about metal-on-metal medical device appliances and their adverse impact on human health.

According to research, said The Telegraph, medical regulators in the U.K. issued new advice for the more than 40,000 Britons implanted with the devices amid concerns that metal-on-metal devices are more dangerous than first believed. (more…)

House Democratic lawmakers are seeking Congressional hearings on transvaginal mesh and Allergan Lap-Band medical device products. The group says the devices post hazards to patients.

Representative Henry Waxman (Democrat-California) and three fellow lawmakers have asked key Republicans in the House Energy and Commerce Committee to hold the hearing and order involved device makers to provide documentation, said Bloomberg News. The timing of the request is significant given that Congress is considering a U.S. Food and Drug Administration (FDA) overhaul of medical device rules, said Democratic lawmakers in a statement. (more…)

Covidien has issued a recall for its Duet TRS single use cartridges after the devices were linked to three deaths among patients undergoing thoracic surgery, the U.S. Food and Drug Administration (FDA) just announced. The Covidien Duet TRS is a product used in surgery in conjunction with a surgerical stapler.

The recall involves all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units that involve use of this product family in the thoracic cavity. To date, Covidien has received 13 reports of serious injuries and 3 reports of patient deaths following the application of Duet TRS in the thoracic cavity. (more…)

Dutch health authorities are advising women to have certain French-manufactured silicone breast implants removed following a worldwide health scare involving device rupture and cancer.

Recently health authorities in France advised about 30,000 women who received Poly Implant Prothese (PIP) silicone breast implants to have them removed over rupture risks. The debacle began following the death of a French woman who received PIP implants and developed rare aplastic large cell lymphoma (ALCL), said Reuters. The devices have not yet been definitively linked to cancer; however, no less than eight other cases of the rare ALCL have been reported among French women who received PIP implants. PIP is now defunct and is the focus of a French criminal investigation. (more…)

Advocacy group, Public Citizen, wants the Stryker Wingspan Brain Stent recalled following a recent study that linked the stent system to a significant increase in stroke or death. Ironically, the Wingspan stent system is meant to prevent stroke by clearing blood flow to the brain.

A former official with the U.S. Food and Drug Administration (FDA) has joined Public Citizen and other advocacy groups in seeking the federal government’s withdrawal of the Stryker device, said Bloomberg Businessweek. According to Public Citizen, a recent National Institutes of Health- (NIH) funded study revealed that the Stryker Wingspan stent system was linked to a 2.5-fold increased risk for stroke or death, wrote Businessweek. The advocates filed their petition—co-signed by a former executive from the FDA’s device division—this Wednesday.
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Makers of transvaginal mesh products have been ordered by U.S. regulators to conduct studies. Today, the devices are the focus of many hundreds of lawsuits involving dozens of manufacturers. According to Bloomberg, manufacturers of such devices are facing more than 600 lawsuits over alleged transvaginal mesh complications.

Johnson & Johnson, C.R. Bard, Endo Pharmaceuticals Holding Inc., and Boston Scientific Corporation, among others, have just been ordered by the U.S. Food and Drug Administration (FDA) to study links between their vaginal mesh implant products and organ damage, infection, and painful sex rates, said Bloomberg News. Device makers—33 in all—received FDA letters this week, asking them to compile three years of data on implant safety and efficacy, William Maisel, deputy director of science for the FDA’s device-approval center, told Bloomberg News. (more…)

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…)