Medical device implants Companies

Medical Device Manufacturer Looks to Haas for Machining Needs | Haas

Der jüngste Eklat in der Medizintechnik hat eher unscheinbar begonnen. Frankfurt / Paris The recent scandal in medical technology has begun rather unimpressive. But now, a scandal developed with sufficient urgency to provide the legal framework for the entire medtech industry into question. Because the events surrounding the French company Poly Implant Prosthesis (PIP) and their faulty breast implants are the view of many experts a clear warning that speaks for a tougher regulation in this market. As in the past ten years already, the pharmaceutical industry and medical device manufacturers must adapt to higher registration hurdles and tighter controls.

Speaker of the professional societies for aesthetic surgery about calling for a reform of the blind and partially incomplete medtech regulations. "The traditional forms of audits is insufficient. It would also give unannounced spot market "demands about Peter Vogt, Professor of Plastic Surgery and President of the Professional Association of German Society of Plastic, Reconstructive and Aesthetic Surgery (DGPRÄC).

The central association of statutory health insurance (SHI) is confirmed in his call for stricter approval procedures and reporting requirements. "The case of PIP shows that we need a medical registers in Germany, " said a spokesman for SHI. Because no one had been a complete overview of what women these implants were used.

Control with gaps
  • Risk classes

    Medical devices are classified into four risk categories with different registration requirements. Even in the highest risk level but so far there is no regular review of the products.

  • Announcements

    Both manufacturers and physicians are under the Medical Device Directive obliged to report problems with medical technology products to the Federal Institute for Drugs and Medical Devices. They often come with this obligation, but only by hesitant.

Some new rules have been put in place in recent years. An EU directive which provides for more accurate clinical trials for products with a higher risk has been implemented into German law in 2010. At the EU level is also discussed, to revise the Medical Device Directive and again to develop criteria for a better quality of inspection bodies.

Rise to a more stringent product control is especially the unusually long period over which the French company was able to deliver implants with inferior quality and unapproved ingredients. For at least a decade, perhaps even longer, put a standard PIP silicone oils are not approved for implants. Has supplied the material of the German chemical distributors Brenntag.

Biomedical Research Publishing Company Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2011
Book (Biomedical Research Publishing Company)
2008-11-26 10:26:52 by stache

Part 2 -

“In a nonapproved case, it’s essentially a little research project going on because we don’t know if these tissues and structures in that area are going to behave in the same way as the tissue the device was approved for,” said Stephen Li, the president of Medical Device Testing and Innovations of Sarasota, Fla., a company that develops materials for medical implants and a consultant to the F.D.A. panel.
Patients aren’t always aware that treatments they are having are off-label. The F.D.A. prohibits companies from marketing unapproved uses. Representatives from Allergan, Medicis, BioForm Medical (the maker of Radiesse) and Artes Medical (the maker of ArteFill) said they did not promote off-label uses

2007-09-08 13:16:15 by ---------

Chip implants shown to cause cancer, f

Late last year, Albrecht unearthed at the Harvard medical library three studies noting cancerous tumors in some chipped mice and rats, plus a reference in another study to a chipped dog with a tumor. She forwarded them to the AP, which subsequently found three additional mice studies with similar findings, plus another report of a chipped dog with a tumor.
Asked if it had taken these studies into account, the FDA said VeriChip documents were being kept confidential to protect trade secrets

2007-09-10 11:01:46 by BabyKanuk

And again

When the FDA approved the device, it noted some Verichip risks: The capsules could migrate around the body, making them difficult to extract; they might interfere with defibrillators, or be incompatible with MRI scans, causing burns. While also warning that the chips could cause "adverse tissue reaction," FDA made no reference to malignant growths in animal studies.
Did the agency review literature on microchip implants and animal cancer?
Dr. Katherine Albrecht, a privacy advocate and RFID expert, asked shortly after VeriChip's approval what evidence the agency had reviewed

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