MASSDEVICE ON CALL — A U.K. researcher tasked with defining the health risk for the nearly 50,000 women who were given substandard implants concluded that the devices were unlikely to cause long-term health problems.
The implants were pulled from shelves amid quite a kerfuffle last year when investigators discovered that Poly Implant Prosthèse was using industrial grade silicon, rather than medical grade.
The products may rupture in as many as 1 in 3 women, researchers said in April, but the leaked silicon isn’t likely to leave long-term damage, according to U.K. National Health Service medical director Bruce Keogh, who conducted the latest study.
Ortho and cardio devices made up “nearly all” Medicare implant spending in 2009
The Government Accountability Office conducted a review of medical implant trends in the U.S., finding, among other things, that: about 1.6 million medical device implant procedures were conducted in 2009, costing Medicare roughly $20 billion; orthopedic and cardiac devices made up "nearly all" Medicare implant-related spending in 2009; admission rates for orthopedics were "substantially higher" in 2009 when compared with 2003, while admission rates for cardiac devices were "mixed," partially reflecting the growing ability to conduct the procedures on an outpatient basis.
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NuVasive wants a 10-year tax break to expand in Tennessee
NuVasive Inc. (NSDQ:NUVA) promised to invest nearly $75 million, create 17 jobs and generate $4.5 million in new tax revenue in expanding its operations in Memphis, Tenn., but the company wants a 10-year accommodation in return.
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Eschenbach and Hall take on the FDA
Former FDA commissioner Dr. Andrew von Eschenbach and MR3 Medical CEO Ralph Hall tear into the FDA’s "outmoded and needlessly long" medical device review process, calling for some remodeling to provide alternatives to clinical trials, enhance post-market surveillance and promote more collaboration between regulators and industry.
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No over-time pay for drug company sales reps
A split Supreme Court ruled 5-4 that pharmaceutical companies are not required by law to pay over-time to their salespeople, classifying them as "outside salesman" who are exempt from laws providing extra pay for workers to put in more than 40 hours per week.
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