Update by Tom Maling
The government agency responsible for regulating medicines and therapeutic goods, the Therapeutic Goods Administration (TGA), issued a hazard alert in May 2017 for the Absorb Bioresorbable Vascular Scaffold (BVS) System. This is a stent inserted into blocked arteries during coronary angioplasty surgery.
All stock has been recalled, and consumers who have had this device implanted during coronary angioplasty surgery were advised to contact their doctor. The TGA has also removed this device from the register, meaning it is not approved for use at this time.
The reason for the alert is growing evidence of increased risks of major cardiac events such as heart attack and blood clots in patients who have this stent. Patients have had to undergo further treatment in order to re-open the affected artery and mitigate the increased risks. In its advice to consumers, the TGA advised:
If you experience any new cardiac-related symptoms, such as irregular heartbeats, chest pain, or shortness of breath, seek immediate medical attention.
It is imperative that consumers who believe they may have had this stent implanted contact their doctor. For more information on the alert please see the below links. You can also contact elringtons lawyers and speak to a health lawyer to discuss your options if you or a loved one has been affected by this stent.
- TGA Safety Alert
- TGA Hazard Alert
- Absorb Bioresorbable Vascular Scaffold system recalled over heart attack fears