Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, January 28, 2013

Biomet Knee Warranty: Patient Advocates Not Buying It!

Go to the link  Biomet direct-to-consumer ad now running on TV in the U.S.   The Biomet knee warranty is here.

What the warranty should say:

1. This device is designed to last for _______ years.  
2. Normal use is defined as ____________.
3. Patients will encounter no legal/paperwork barriers to accessing the warranty.        
4. Hospital and testing costs are fully covered.The product cost is incidental to patient harm costs such as lost income, pain and suffering. 
5.  Revision is failure and prompts payment under the warranty.  Increased function and pain reduction are expected. Introduction of new patient harm such as exposure to toxic materials or need for increased medical intervention is a failure.  
6. Patients should bear no expense for testing costs for devices with sub-optimal results.
7. Immediate patient compensation in contested cases is assured. Financial responsibility is pre-defined in a default agreement between producer/hospital/surgeon.    
8. Like MSDS sheets, every source and material in the device is listed and the long term health issues related to exposure are disclosed.  Such documentation must be provided to the patient in pre-op informed consent along with history of FDA product approval(510k or PMA) and number implanted to date.
9. A comprehensive federal implanted medical device registry is fully public and free. Exercised warranties will be immediately visible.  The medical device industry functions in a transparent and ethical manner to the benefit of the nation and citizens of the United States.  Profit reflects the value of its' contributions to the health of patients.

Concerns that Prompted this Blogpost:

Direct-to-consumer ads are intended to drive sales.   "The industry's only Lifetime Knee Implant Replacement Warranty in the U.S." is limited to the cost of the component only--not covered are hospital and surgeon fees, related surgery living costs (travel, hotel, transportation, etc.), and loss of economic benefit while surgery is repeated.

Prior to Biomet and the implanted medical device industry reaching the conclusion that "less is more" and advertising an (anemic but much-needed) warranty thousands of patients remain harmed and uncompensated. 

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