Recent problems with medical implants have led to an investigation into FDA approval practices, manufacturers’ sales tactics and unethical payments to surgeons who install the implants. One case under scrutiny involves patient Katie Korgaokar[1] who received the DePuy ASR hip implant, which later failed. She had no idea that her doctor collected $600,000 from DePuy in exchange for using only DePuy implants.
FDA Shows Poor Record in Recalling Defective Implants
The United States Senate recently called FDA experts in for a hearing about repeated problems with metal-on-metal hip implants like the ASR implant that failed for Ms. Korgaokar. The senators complained that the FDA failed to protect patients from these defective implants. The agency does not track implant results, which means they have no information on failure rates for the medical devices. The FDA only finds out about problems when a patient complains about a failure. Senators worry the agency failed to warn doctors and their patients adequately about problem devices.The United States Senate recently called FDA experts in for a hearing about repeated problems with metal-on-metal hip implants like the ASR implant that failed for Ms. Korgaokar. The senators complained that the FDA failed to protect patients from these defective implants. The agency does not track implant results, which means they have no information on failure rates for the medical devices. The FDA only finds out about problems when a patient complains about a failure. Senators worry the agency failed to warn doctors and their patients adequately about problem devices.
Woman’s Implant Leaked Metal
Katie Korgaokar learned that the hip replacement she received was under recall when she saw a news report on television. The FDA had approved the implant without a full examination because the device was similar to other implants that have been on the market for many years. This controversial system of approval is called the 501(k) plan.
When doctors tested Katie’s blood, they found the replacement hip had leaked metal into her blood stream. Katie underwent surgery again so doctors could remove the bad implant and replace it with a safer and more reliable one. The metal in Katie’s blood forced her to delay plans to become pregnant. She worries that the contamination may make it impossible for her to conceive in the future.
Doctors Received Payments from Device Manufacturers
After Katie’s second surgery, she learned that her original implant surgeon received payments from DePuy as a consultant. During the senate investigation, senators learned that many implant manufacturers routinely pay doctors to use their implants only. Because doctors do not tell patients about these payments, patients assume the doctor’s advice is based on the treatment that will benefit the patient most, not the treatment that will benefit the doctor most.
Implant Manufacturers Ordered to Pay Fines
Once legislators learned about the payments, several implant manufacturers faced federal fines in the millions for physician payouts. The Department of Justice said that implant manufacturers must release information about their partnerships with doctors in the future. Implant manufacturers argued that their financial relationships with doctors were ethical. Manufacturers need doctors to help them design better implants, and the payments were for the doctors’ advice. However, as long as those payments also limit doctors to a particular brand of medical device, the payments remain unethical. Doctors must make decisions that are best for the patient, regardless of financial incentives.
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If you suffered a failed hip implant, contact our office for a free consultation. We will examine your case and help you decide if a hip replacement lawsuit is the right course of action for you.
[1] http://aging.senate.gov/hearing_detail.cfm?id=332473&
