Sunday, May 29, 2011

Medtronic Spine Products and Risks of Male Infertility?...?

I haven't read the "Spine Journal Original Article yet, so not sure what the details of the study that indicate risks of male fertility by Medtronic's inufse bone graft. But, the news certainly must open up further investigation and scrutiny, Patient safety should be given top priority.

Medtronic Infuse Bone Graft Lawsuits

The Infuse bone graft lawyers at Saiontz & Kirk, P.A. are investigating potential Medtronic lawsuits for individuals who have experienced problems after surgery on their cervical spine. 
Medtronic has been accused of actively promoting and marketing the Infuse bone stimulator off-label for use in the cervical spine, or neck.  They have also failed to adequately warn about the risk of life-threatening complications.
Potential Medtronic Infuse bone graft lawsuits are being evaluated throughout the United States for problems associated with use during neck surgery.  There are no fees or expenses unless a recovery is obtained.

BusinessWeek LogoStudy links Medtronic's Infuse to male infertility

A study published Wednesday links Medtronic Inc.'s Infuse spinal graft to a condition that can cause infertility in men.
The clinical study said men who were treated with Infuse were more likely to develop retrograde ejaculation than men treated with other bone grafts. Retrograde ejaculation is a condition in which semen goes into the bladder after ejaculation instead of leaving the body through the urethra. It's not harmful, but it can cause infertility.

MAY 26, 2011, 5:33 P.M. ET
Study Shows Male Infertility Risk With Medtronic Spine Product

The experiences of one surgeon are raising questions about the costs and risks of a Medtronic Inc. (MDT) bone-growth product, threatening to pressure further the company's spinal business.
According to a study made available Wednesday by The Spine Journal, men treated with Medtronic's Infuse product were more likely to develop a certain infertility problem than those who didn't get the product during spine surgery. Editorials in the medical journal questioned why the issue wasn't examined more in Medtronic-funded studies and noted Infuse's high price tag.
The study, though, has limitations because it's based on procedures done at one hospital by ... 

New Study Links Spine Product From Medtronic to Risk of Sterility in Men

A surgeon at Stanford University, in a study released Wednesday, suggests that one of Medtronic’s best-selling spinal products poses a risk of male sterility. That finding is in stark contrast to earlier research by doctors paid by Medtronic, who found no connection between the product, Infuse, and a condition that causes sterility. 

Medtronic site published this description of the product?
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE® BONE GRAFT/LT-CAGE® LUMBAR TAPERED FUSION DEVICE
INFUSE® BONE GRAFT/INTER FIX™ THREADED FUSION DEVICE
INFUSE® BONE GRAFT/INTER FIX™ RP THREADED FUSION DEVICE
The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. The INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach. INFUSE® Bone Graft with either the INTER FIX™ or INTER FIX™ RP Threaded Fusion Device is to be implanted via an anterior open approach.To Read further:
https://www.infusebonegraft.com/infuse_indications.html

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Search about: Neuromonitoring

NeuroMonitoring Companies: Europe

Providers in Europe:
Intraoperative Neuromonitoring Practice at UniversitatsSpital Zurich:

NeuroMonitoring Suppliers in Europe:
1.CPS Medical: NeuroCode AG

NeuroMonitoring Supplier in Russia:
1.Neurosoft, Medical Diagnostic Equipment
Worldwide Distribution list

IONM in New Zealand:

What are the chances of getting a job?

Opportunities to get into neurophysiology technologist jobs are very limited, as there are only 20 neurophysiology technologists employed in New Zealand.

IONM in Switzerland:
Anandic Medical Systems a local Swiz company with GE Partnership that does neuromonitoring and neonatal pediatric neuromonitoring monitoring.

Medical/Health Care: Insurance Companies and IONM Policies, in their Eyes!?

Here is what the insurance Co Anthem Blue thinks about what is medically necessary or investigational as per their policies!

BlueCross BlueShield of Tennessee Medical Policy Manual

  • Intraoperative neurophysiologic monitoring, including, but not limited to the following: Somatosensory-evoked potentials, brainstem auditory-evoked potentials, visual-evoked potential, EMG, motor-evoked potentials, and EEG, when performed during spinal, intracranial, or vascular procedures, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

  • Intraoperative neurophysiologic monitoring for other indications is considered investigational.

  • Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational. See also: Visual and Auditory Evoked Potential