Warranty should give patients all the information they need
What I would expect from a good warranty:
1- Description of all types of risks involved for health and safety 2- Lists of symptoms of failure of the device for use with doctors who may have to treat device failures and health harms. 3- Lists of suitable and approved medical tests, imaging, blood tests, fluid samples at joints, MRI, ultrasound, and other means to discover extent of device failures 4- How I will be informed of a recall or potential problems occurring with the implant device in other patients 5- Evidence (graphs, statistics, test data, findings) of how the device was tested in comparison of alternative implant systems 6- Independent studies of the device (if any) to corroborate the Warranty Claims as written. 7- How device warranty claims will be filed, with who, how, what and when in case of device failure, malfunctions, dislocations, infections, health complications and reported problems by other patients (publicly available data, hospital tracking, agency tracking, Federal or FDA data) for complaints and device problems. 8- What forms and evidence of failure must be completed in case of Warranty Claims for health harms and device failures 9- What instructions do I give to my Primary Care Doctors, Ortho-surgeon, Medical Specialists, Hospitals in case of a problem with the Implant device. 10- What training and certifications must my surgeon and the surgical team have completed in order to surgically implant the device into my body. 11- Complete listing of ancillary risks associated such as for medications (pre-surgery), antibiotics required, types of infections, hospital errors, medication errors, wrong diagnosis and so forth. 12- Expectations for my surgeon and surgical team for complete surgical records, documentation, imaging, medications, dosages during the implant surgery, post-surgery recovery period and annual exams to validate satisfactory performance under Device Warranty 13- Records of FDA-CDRH Clearance – tests performed, reviews conducted, FDA contact list, FDA website information, and Certifications provided for Market and pre-market/post-market evaluations records (public information sources), who to file device failure or medical complications complaints under the Warranty 14- Where is the Warranty Posted on the Manufacturer’s Website or in the Public Record (FDA, Federal Registry, Library, CMS/HHS/Medicare/Medicaid, Hospital or other) 15- Manufacturing Data – country where manufactured, including all components, parts, pieces and systems for surgical insertion into the body. Tracking data for all components such as serial numbers, device marking identifiers, and manufacturing certification records 16- Manufacturers contact information, phone, e-mail, fax, website and other means to locate direct service for device failure or complications. Requirement to provide future changes in contact information directly to hospitals, surgeons and patients. 17- How will recall notices and announcements and other types of component and/or device failures be made publicly available so patients and surgeons become aware of problems. 18- What steps will the Device Manufacturer take to maintain awareness of failures, malfunctions, health complications involving the Warranty Conditions? Who will do these steps? 19- What steps must hospitals, surgeons and primary care doctors take to remain aware of information in #18 above. 20- What legal recourse is available to patients who experience failures and medical problems. What hotline or other advocacy agencies are available for counseling on the Warranty Provisions at State or Federal levels? How will payments to reimburse CMS/Medicare for medical costs, surgeries, tests, hospitalization and so forth be processed and by whom (other that the patient who experienced the failure).
Metal-on-Metal DePuy ASR (Johnson & Johnson) Hip Implant was implanted in 2006 at recommended urgings of my wife’s uninformed orthopedic surgeon. Severe pain was immediate and ongoing for over four years until another surgeon removed the implant in December 2010 (4 months after NBC TV News broadcast the “Recall” of the device). We later discovered millions of dollars of J&J payoffs to doctors were made to promote the toxic-metal device. One surgeon received over $1 million “consulting fees” to “hard sell” the metal-on-metal implants. The surgeon obviously didn’t understand the toxicity risks of cobalt and chromium debris and toxic buildup in blood serum. No warning materials were provided to us by the manufacturer, DePuy Orthopaedics (U.S.A.), prior to the recall. My wife’s surgeon verbally told both of us the implant “cup” didn’t require screws or pins to hold it in place due to its new design. This proved to be a false, uninformed statement. Due to the toxic devices metal debris and tissue rejection (metallosis) the ASR cup NEVER attached to her hip bone. My wife had to put on a support belt around to her hips every morning to alleviate pain levels so she could walk. X-rays didn’t reveal the fact that her implant was not attached to bone. Toxic metal debris-impacts of Chromium and Cobalt ions were even greater damage to my wife. She developed neurological memory loss; severe heart arrhythmia (heart rate spikes); nerve, tissue, and muscle damage; giant cells formation (fluid sacks) around the metal joint; a tumor formed; and ensuing severe disabilities due to instability. Other symptoms were hearing (tinnitus) loss and vision loss; foggy memory; depression; and inability to sleep due to constant pain. Even though we asked both in writing and verbally that the implant cup be saved and returned to us post-surgery, it mysteriously disappeared. We later found out in news publications that DePuy was paying hospitals to recover the metal implant “evidence” until a Federal Court ordered them to cease and desist. My wife has not fully recovered and will be permanently disabled. She cannot walk further than a hundred feet unassisted. Every day she is in severe, ongoing pain due to loss of tissue, muscle and nerve damage in the implant region of her hip joint. Our former health insurance company (Humana) and Medicare CMS/HHS have BOTH sent demand letters that we repay them for costs of the toxic implant surgical procedures and ongoing physical therapy, medications, hospitalization and doctor visits. This is a further financial and emotional burden for many victims of DePuy’s recalled hip implant; and lack of proper human testing before paying fees to doctors to promote and implant the medical devices into uninformed victims. We’ve contacted Johnson & Johnson (no response); both US Senators (Cantwell & Murray); State Health Department; FDA; CMS/HHS Medicare Seattle Office; American Academy of Orthopedic Surgeons; Overlake Hospital (Bellevue); AARP; and numerous other advocacy agencies (only Senator Cantwell made progress to get FDA to post warnings on their website in 2007).