The cabinet secretariat has written to the Department of Health Research (DHR) to take necessary actions after parliament member Ajeet Madhavrao Gopchade raised concerns over unregulated use of dental implants in the country and the absence of a uniform safety and quality framework governing their manufacture, sale, and clinical use.
Dental implants are increasingly used not only for replacing missing teeth but also in oral cancer rehabilitation, facial reconstruction and other complex medical procedures, making them long-term implantable medical devices rather than routine dental consumables, the MP noted.
Any compromise in implant material quality, sterility, biomechanical strength, implant-abutment compatibility or manufacturing precision could lead to serious complications ranging from bone loss and implant fracture to chronic infection, nerve injury, repeated reconstructive surgeries and facial deformity, Gopchade said in a note to the cabinet secretariat.
Yet, there are increasing concerns over non-standardised and low-quality implant systems, unverified imported implant materials, misleading commercial advertisements and “lifetime guarantee” claims, absence of uniform implant biomaterial standards, lack of implant traceability mechanisms, variable levels of implantology training, and the absence of national long-term monitoring and adverse-event reporting systems.
Gopchade noted that countries such as the US, UK and Australia require extensive testing, traceability and practitioner standards for implantable dental devices.
He asked the government to consider constituting an expert committee to examine the feasibility of establishing a comprehensive National Dental Implant Safety and Regulatory Framework for India.