FD-2, an Anticervical Stenosis Device for Patients Undergoing Radical Trachelectomy or Cervical Conization

Abstract

This study aimed to introduce FD-2, a newly developed anticervical stenosis device for patients with cervical cancer undergoing radical trachelectomy. Using ethylene-vinyl acetate copolymers, we developed FD-2 to prevent uterine cervical stenosis after radical trachelectomy. The tensile test and extractables and leachables testing were performed to evaluate FD-2’s safety as a medical device. FD-2 was indwelled in three patients with cervical cancer during radical trachelectomy and its utility was preliminarily evaluated. FD-2 consists of a head (fish-born-like structure), neck (connecting bridges), and body (tubular structure); the head is identical to FD-1, an intrauterine contraceptive device. FD-2 passed the tensile test and extractables and leachables testing. The average time required for the application or removal of FD-2 in cervical cancer patients was less than 10 s. The median duration of FD-2 indwelling was 8 weeks. No complications, including abdominal pain, pelvic infections, or hemorrhages, associated with FD-2 indwelling were reported. At the 3–12-month follow-up after the radical trachelectomy, no patients developed cervical stenosis or experienced dysmenorrhea. In conclusion, we developed FD-2, a novel device that can be used for preventing cervical stenosis after radical trachelectomy for uterine cervical cancer.