What You May Not KnowWhat You May Not Know

  1. In every operating room in America, the salesperson who sold the device to your surgeon is in the room with you during surgery. Sometimes, there is more than one and many times, they touch or move you to assist the surgeon. That salesperson and the company who hired him/her is not required by law (check your state but not in California) to have a background/criminal. To find out who was in your operating room, you must get the detailed hospital report. This is NOT the “Op Report” by the surgeon’s office.

    What to Do: Ask the surgeon beforehand who will be in the room with you for your revision surgery and get the detailed hospital report.

  2. The hospital report may not include or delete items during about your hospitalization. There are several examples by patients who had problems but were not noted in the reports. My own example: While at Sharp Memorial Hospital in San Diego, I awoke from surgery with a large chip in my front tooth. I asked appropriate personnel how this happened. The anthestsiologist told me they did not know but “perhaps I bit down too hard on the thermometer in recovery”. (note: this is why in the pre op report you have to list if you have any chipped teeth). After I was released and secured my 350 page report, there was no mention of my chipped tooth. I complained to the hospital that I had to pay to get my tooth fixed and they promptly refunded my money.

    What to Do: keep a record as soon as you are awake you think of what you think noteworthy. Have a loved one or designate a patient advocate to help you if possible.

  3. X-Rays: An MRI may not pick up an acetabular cup that is not bone ingrown. I had three and none of them did. Do not assume there is not a problem if you are told it looks fine, “in good position”. A CT without contrast may also not show loosening.

    What to do: Get a 3-D CT and talk to the radiologist. Tell him/her you suspect necrosis. They will not understand metallosis. Make sure you get the disc before you leave. Insist on a mailed report as well (they will not fax due to HIPPA) so you will have to wait for it by mail.

  4. If you have the device explanted, try and keep a journal of what you felt before, during, and after. This is important for you mentally and emotionally and may be helpful when you file a lawsuit. Coordinate with the hospital and surgeon that you want the explanted device uncleaned. My doctor took digital pictures of the device and tissue in the operating room and the device was delivered to me by a bio hazard rep of the hospital. I have it in a plastic bag, padded, and it has never been touched since. This may help insure that DePuy cannot run its own tests or claim others may have altered it.

    What to Do: Do not give your explanted device to DePuy or let your doctor provide. It is your device, you bought it and so did your insurance company via the premiums you paid.

  5. You don’t have to have the surgeon who implanted the device take it out. On the contrary, look for a doctor who did not use a metal on metal device and has no allegiance to DePuy. If you like your surgeon and feel he was being truthful with you and listened to your complaints of pain, he may be fine to remove the device but remember that same DePuy rep will be in the operating room documenting the procedure.

  6. In my opinion, do not fill out any paperwork your doctor sent you from DePuy. Rather, ask your doctor, “How many of these devices did you implant in the last year?” If he answers over 200, he is a very good client of DePuy. Get an attorney to do this first.

    What to Do: Get legal representation first and not from an attorney advertising on television, print, or online. Get an expert attorney in medical device litigation, preferably with hips. Interview this attorney in-person. It will be one of the most important decisions you can make about your health. Get references and talk to other plaintiffs who have been successfully defended by the attorney. You don’t have to discuss settlement but you can ask questions not related to an out-of-court settlement.

  7. A PDF of the ASR XL System DePuy had given to doctors in 2006 is available. You should secure this and read it. It will help you understand part by part what is inside of you and see how the DePuy and the designing orthopedic surgeon sold this to the the orthopedic community.

    What to Do: Ask your doctor (or attorney) for a copy of it. It is very helpful to have in order to understand each part of the system. (It also gives plenty of room in the fine print to make sure if the doctor does not implant the device just right, its is his fault if it fails). This has proven quite impossible as the design of the acetabular cup is shallower and has a ridge inside the cup. This was as done to circumvent the Birmingham Hip patented system, a competitor to DePuy that both Drs. Schmalzreid and Vail encountered when designing the ASR system. Compensation to these doctors exceeded 7 million dollars.

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  8. The ASR XL system was not FDA approved via clinical trials. This system was allowed under an FDA loophole called a 510(k).This can occur under a manufacturer’s existing patent. The theory is, if a system such as a hip prosthesis has passed all clinical trials prior to and received patent approval, a “new and improved” version does not have to undergo the same rigorous trials.

    What to Do: Contact your local Congressman and ask him or her to look into this and provide them with links to help educate them. Their constituents are being harmed and they need to have their voices heard. It has particularly affected women who are a powerful force politically. Do not underestimate your voice when mobilized on the internet.

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