At first blush, a study recently published in the New England Journal of Medicine provides slightly contrarian findings about the benefits of using surgery for treatment of early stage prostate cancer in men under 65. There has been a great deal of discussion about the perceived over-treatment of prostate cancer in the US, specifically focusing on the use of surgery and robotic surgery for patients who could potentially be well-served by watchful waiting.
This new study, performed by the University Hospital in Uppsala, Sweden, indicates that there was a significant reduction in the rate of death from prostate cancer in the study group that received radical prostatectomy, as compared to the group that received active surveillance. With other recent studies suggesting questionable benefits of surgery over watchful waiting for management of patients with early stage disease, there is still a lack of consensus on the appropriate way to balance the use of these treatment approaches.
Debate Continues Over Role of Surgery for Early Stage Prostate Cancer
The controversy surrounding metal-on-metal hips, whose bearing surfaces can cause a dangerous accumulation of metal ions in vitro as the implant wears over time, has already lead to a public health warning by the FDA. Today, in one of the "broadest use of the agency's authority to conduct studies of devices after approval for sale," the FDA has ordered 21 manufacturers of metal-on-metal total hip replacement systems to conduct post-market surveillance studies of their devices to assess metal toxicity risks.
The vendors have thirty days to submit plans for a post-market study which the FDA is recommending be an eight-year surveillance study that looks at adverse events in patients with metal-on-metal hips. Levels of chromium and cobalt in patients' blood at baseline and each year post-implant for up to eight years have been suggested as basic data that will be needed. The data request, however, does not end there. Vendors should also be investigating revision risks, demographic groups that have especially high levels of blood toxicity, as well as cardiac, neurological, and immunosuppressive events that could be correlated to the ionisation of the blood caused by these implants.
With these escalating concerns and increasing physician and patient resistance to these types of implants, it may be only a matter of time before metal-on-metal hips fall completely out of favor among the orthopedic community. At the same time, these concerns have been around for awhile and metal on metal continue to account for roughly a quarter of the 260,000 hip replacements performed each year. But, as the concerns continue to mount, an impact will certainly be felt.
For industry, the impact will fall disproportionately on DePuy, whose hip business has already suffered from a major recall announced last year. For providers, being increasingly careful on utilization of these implants and following closely the development of this story will be imperative.
On Friday, May 6, the United States Food and Drug Administration (FDA) approved expanding indications for use of Abbott Vascular's carotid artery stent--the RX Acculink CarotidStent System--to include patients at standard surgical risk for carotid endarterectomy (CEA). Previously, Abbott's stent system, which is used together with either its Accunet or Emboshield embolic protection devices, was approved exclusively for use in patients at high surgical risk and requiring carotid revascularization. Patients considered high surgical risk were required to have a reference vessel diameter between 4.0 and 9.0 millimeters at the target lesion. In addition, patients had to meet one of these requirements:
- Neurologic symptoms with > 50 percent stenosis of the common or internal carotid artery (symptomatic)
- No neurologic symptoms but > 80 percent stenosis of the common or internal carotid artery (highly symptomatic)
FDA Approves Expanded Indication for Carotid Artery Stenting Following CREST Results, Expert Panel Recommendation