On August 24, 2010, the FDA announced that there was a voluntary recall by DePuy of their ASR™ metal-on-metal total hip system, because the revision rates within five years were approximately 13%.1 My father had his hip replaced with this device in 2008. This winter, unfortunately, he required a revision of his hip; the revision was complicated by a pseudomonas infection requiring drainage, re-hospitalization, and antibiotics.
As health care providers, we are well aware that there are risks to all surgeries and procedures. We also recognize that medical devices can have major performance problems well after the devices have been approved by the FDA. However, as heart rhythm specialists, we continue to be stunned by the frequent occurrence of implantable device and lead recalls. The recent inside-out abrasion problem with the St. Jude Medical Riata® silicone defibrillator lead is just one more example of a transvenous lead that fails at an unacceptable rate, and by a mechanism not seen before.
There have been repeated calls for a more stringent approval process of medical devices by the FDA, better post-market approval surveillance, and better tracking of device performance by the industry. However, there has been much less attention to the costs associated with these problems. Physicians and hospitals routinely manage and bill patients who need procedures for cardiac device problems, regardless of whether or not the device was recalled. But who pays for this — the insurance company, Medicare, the patient, or the company? And who decides who pays? The company?
A recent estimate of the cost of managing the approximately 175,000 patients with a recalled Medtronic Sprint Fidelis® implanted defibrillator lead who were still alive in the United States found that the cost of the lead recall just to Medicare would be $287,000,000.2 This estimate is conservative, given that it was based on a model that assumed an annual failure rate of 1.8% over the first five years. The failure rate, subsequently, has been shown to be much higher. A recent Canadian report has determined that the failure rate is more like 17% at five years.3 Does that mean the cost to Medicare related to the Fidelis® lead problem will be $3 billion?
The maker of the recalled metal-on-metal hip prosthesis, DePuy, offered to cover all medical expenses related to the management of the recalled hip. “DePuy is working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs.”4 Therefore, theoretically, my father will have no out-of-pocket expenses related to his hip revision. It should be added, however, that after six months and multiple requests, he has received no compensation yet. Regardless, the offer to compensate all out-of-pocket expenses is not something seen in the pacemaker/defibrillator industry. In the November 28, 2011 St. Jude Medical Device Advisory letter to physicians, the compensation offer to patients was limited: “in the event you determine that it is appropriate to replace a Riata or Riata ST silicone lead that exhibits externalized conductors, we will provide a replacement Durata lead at no charge and up to $600 in unreimbursed medical expenses.”5
As efforts are made to protect heart rhythm patients by improving the performance of implantable cardiac devices, efforts must also be made to financially protect heart rhythm patients and providers from the enormous costs associated with managing patients with recalled pacemakers and defibrillators.
- “Medical Devices.” Recalls. U.S. Food and Drug Administration. Accessed 12 Apr. 2012. <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm>.
- Mehrotra AK, Knight BP, Smelley MP, et al. Medtronic Sprint Fidelis lead recall: Determining the initial 5-year management cost to Medicare. Heart Rhythm 2011;8:1192–1197.
- Birnie DH, Parkash R, Exner D, et al. Clinical predictors of Fidelis lead failure: A report from the Canadian Heart Rhythm Society Device Committee. Circulation 2012;125:1217–1225. Epub 2012 Feb 6.
- ASR Hip Replacement Recall Guide. DePuy. Accessed 12 Apr. 2012. <http://asrrecall.depuy.com/asr-hip-replacement-recall>.
- “Medical Device Advisory Important Product Information Update.” Letter. 28 Nov. 2011. St. Jude Medical. Accessed 16 Apr. 2012. <Nov_2011_Important_Product_Information_Update_Riata_112811.pdf>.