Defective Medical Devices & Implants

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Modified on 2009/10/14 21:32 by admin
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The FDA’s Center for Devices and Radiological Health (CDRH) oversees firms who manufacture medical devices and implants sold in the United States.  The precise legal authority is governed by the Federal Food Drug and Cosmetic (FD&C) Act.  Medical devices can range from a basic tongue depressor to a complex implantable defibrillator, but all devices are regulated by the FDA.  The perception of what is meant by a ‘medical device’ is often at odds with the regulatory reality.  Some devices are classified as electronic radiation emitting devices (a different category of device still regulated by the CDRH) and some are classified as medical devices.  The medical devices that are also electronic radiation emitting devices, and must follow additional sets of controls during FDA premarket approval. 

The law defines a medical device as "an instrument, apparatus, machine, implant, or other similar article that is intended for use in the treatment or prevention of disease." Medical devices can be anything from a breast implant to a pacemaker to a hearing aid. The term is very broad and includes items that the public may not consider to be medical devices, such as condoms, as well as the Lasik procedure.

Medical Device Recalls

Some devices that have emerged as problem devices are the Guidant and Medtronic pacemakers and implantable defibrillators.  These heart devices develop problems with the lead wires that connect the defibrillator to the heart.  Guidant has also had trouble with its abdominal aortic stent product about five years ago, a device designed to repair damage from aneurysms. 

The Durom Cup artificial hip joint has developed problems, causing hundreds of patients to require a second hip replacement surgery because of the hip implant has separated painfully from the bone six months after surgery.  Zimmer Holdings, the manufacturer of the Durom Cup, suspended sales of the device in July 2008. 

Some other medical devices have special histories that patients will uncover after minimal amount of research on the internet or after investigating the FDA’s medical device database (MAUDE) of adverse events reports.  It is important to conduct thorough research before you undergo device surgery to uncover any hidden problems with the device or implant.

Some of these problem devices and implants may include gadolinium-based contrast agents, birth control patches, knee implants, penile implants, human tissue transplants, and endoscopes.  Endoscopes have been a problem because they are not consistently clean before being reused from patient to patient.  Scopes are used again and again and not always completely sterilized between patients.  As the medical device industry becomes more diversified, more areas open where patients are exposed to potential injury from increasingly complex implants.

Medical Device Injury



If you are a victim of a medical device injury, a medical devices attorney can help in the event of a device or implant recall by the FDA or the company that manufactured the implant.  Typically, in a medical device lawsuit, the injured party suffers from a ‘signature injury’ that is well-recognized in the medical literature, a ‘signature injury’ that an attorney would recognize as attributable to that particular medical device.  Medwatch adverse events reports will bear out these signature injuries.  It is not necessary to have a so-called ‘signature injury’ in order to recover damages, but not having the established ‘signature injury’ makes the legal process more difficult, given that the client won’t be immediately identified as suffering from a well-established injury.  

Please refer to related subcategories below for more information on defective medical devices and implants.



See Also

  1. Abbott Axsym Beta-HCG Pregnancy Test: Overview
  2. Aneurysm Grafts: Overview
  3. BioGlue: Overview
  4. Bladder Control & Urinary Incontinence Devices: Overview
  5. Bone Screws
  6. Breast Implants
  7. Bronchoscopes
  8. Catheters
  9. Clinipad Antiseptic Sterile Products
  10. Cochlear Implants
  11. Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System
  12. CT Scan: Overview
  13. Dental Amalgams: Overview
  14. Dental Sealants: Overview
  15. Disetronic Insulin Infusion Pumps
  16. Drugs, Medical Devices & Implants: Overview
  17. Durom Cup Artificial Hip
  18. Extended Wear Contact Lenses: Overview
  19. FD&C Blue No. 1 (Blue 1)
  20. Heart Devices: Overview
  21. Hip Replacement
  22. Knee Replacement
  23. Lap-Band: Overview
  24. Medtronic Model 8870 Software Application Cards
  25. Medtronic Paradigm Quick-Set Plus Insulin Infusion Sets
  26. Nellcor CapnoProbe SLS-1 Sublingual Sensors
  27. NeuroCybernetic Prosthesis System (NCP)
  28. Perfix Hernia Plug
  29. ProbeTec ET Instrument
  30. Respironics, Inc. ComfortGel Nasal Masks
  31. Rife Frequency Generators: Overview
  32. Shiley TracheoSoft XLT Extended Length Tracheostomy Tubes
  33. Surestep Blood Glucose Meter: Overview
  34. VIDAS Chlamydia Assay
  35. Medical Devices: Frequently Asked Questions
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