Tuesday, July 3, 2012
Measures undertaken outside the US
Excerpts from Zacks Equity Research on July 2, 2012
In February 2012, the Medicines and Healthcare products Regulatory Agency (“MHRA”) – the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe– increased scrutiny of patients with MoM implant. The agency asked the surgeons that patients with MoM hip replacements with head diameters of 36 mm or more should be monitored annually for the life of the hip replacement. This was done to detect any complication at the earliest so that more complex surgeries could be avoided. The previous advice, issued in April 2010, required monitoring for a minimum of five years after the operation.
This was followed by Health Canada issuing a public health communication to orthopedic surgeons and patients about potential health risks associated with MoM hip implants in May 2012. The agency noted that female patients, patients with increased activity levels, patients who are severely overweight and those with implants in both hips experienced increased risk of adverse local tissue reactions.
Favorable data from Smith & Nephew (SNN) on a new study for its Birmingham Hip Resurfacing (“BHR”) system announced earlier this year provides a lease of hope for this technology. The study, carried out at the request of the FDA, followed the progress of the first 400 BHR patients in the UK. It was observed that after 10 years, 99% were either satisfied or extremely satisfied with their BHR procedure.
Given the mixed reviews, additional and in-depth study on the use of MoM technology is the call of the hour. Meanwhile, MedTech firms in the replacement niche have to counter yet another looming headwind in an already tight playing field.
Posted by Connie at 1:04 PM