About 100 Canberrans with heart problems have been urged to talk to their doctor after a national recall of a dissolvable heart stent linked to a higher risk of heart attacks and blood clots.
Subscribe now for unlimited access.
$0/
(min cost $0)
or signup to continue reading
Heart stents are catheter tube implants inserted into arteries to open blocked arteries and keep them open, mostly used for people with heart conditions.
Two weeks ago, the Therapeutic Goods Administration recalled the Absorb Bioresolvable Scaffold System, a relatively new type of stent that fully dissolves into the body over time.
But the TGA recalled it after data was released from recent analyses "that showed an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with an another alternate stent".
The manufacturer of the stent, Abbott Vascular Australia, also recalled any unused stock and removed it from the Australian Register of Therapeutic Goods, while it continues to be tested in clinical trials in some hospitals to monitor the implant techniques being used.
An Abbott spokeswoman said that data from trials around the world that under current implantation techniques, "efficacy and safety results are comparable to the gold-standard metallic drug-eluting Xience stent".
She said a "very small percentage" coronary percutaneous intervention - or stent implantation - have received the stent.
Some 39,800 Australians underwent operations to implant stents in 2014-15 and while total numbers are unclear, it is likely only a small proportion of patients who recently underwent the operation would have been given this particular type of stent.
Along with state health authorities around the nation, ACT Health has contacted about 100 patients who had the stent implanted in their arteries at Canberra Hospital, urging them to contact their GP.
"ACT Health advised these patients that the stent does not need to be removed, and that the hospital has not observed an increased rate of heart attack or clotting with this stent," she said.
"Advancements in implantation technique used in more recent studies show improvements in safety and decrease in the event rates." the TGA alert reads.
The ACT Health spokeswoman said that patients were advised to contact their GP to ensure they were getting the appropriate combination of blood-thinning medications.
"Any patients experiencing cardiac-related symptoms, such as chest pain or shortness of breath were advised to seek immediate medical attention," she said.
While the stent does not need to be removed from patients, unless on medical advice, the recall related to unused stock around the country and ACT Health and interstate counterparts have begun removing the stent from stock.
The TGA said the Absorb BVS stent would now only be available through clinical trials and under the limited terms of the special access scheme or authorised prescriber scheme.
People with the stent have also been advised to follow their doctor's advice, particularly when taking dual medications known as dual anti-platelet therapy (DAPT), to reduce the risk of heart attacks or clots.
