The health authorities have finally acknowledged ultrasound-guided vacuum-assisted breast benign legion resection, also known as Mammotome procedure, as new medical technology. The procedure had failed to get recognition twice.
The National Evidence-based Healthcare Collaborating Agency (NECA) sent a letter containing the result of its assessment on the Mammotome procedure’s safety and efficacy to the Korea Institute of Radiological & Medical Sciences (KIRMS).
According to the letter, NECA concluded that the Mammotome procedure was safe and effective to remove legions from benign breast lesions, in its seventh meeting of the new medical technology assessment committee.
If the Ministry of Health and Welfare revises the notice on the result of the assessment on the safety and efficacy of new medical technologies, physicians can use the technique to treat patients.
Korea introduced the Mammotome procedure in 1999.
The procedure allows physicians to obtain many tissues when diagnosing a breast disease with higher accuracy. Doctors and diagnose the disease and treat it at the same time. The procedure rarely causes complications or postsurgical scar, compared to conventional mastectomy.
The Mammotome procedure faced a hurdle after many institutions applied for the NECA’s assessment for new medical technology. NECA has kept refusing the applications, saying the procedure had weak scientific evidence to prove efficacy.
That made private insurers ask medical institutions that performed the Mammotome procedures to pay back the medical costs for the procedure. They even pursued civil lawsuits and pressed criminal charges against the hospitals.
The Korean Association of Surgeons has been urging the health authorities to recognize the Mammotome procedure as a new medical technology, saying the academic basis of vacuum-assisted resection was clear.
In its third try, the Mammotome procedure was registered as a new medical technology in Korea.