Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices. DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers. METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications. TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study. CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance.

Gastrointestinal problems in 15q duplication syndrome.

Chromosome 15q duplication syndrome (Dup15q syndrome) is a neurodevelopmental disorder involving copy number gains of the maternal chromosome 15q11.2-q13 region, characterized by intellectual disability, developmental delay, autism spectrum disorder (ASD), and epilepsy. Gastrointestinal (GI) problems in Dup15q syndrome have been reported only rarely, mostly focused on neonatal feeding difficulties. A retrospective review of the medical records of 46 patients with Dup15q syndrome was conducted to assess GI issues and their treatments in this population. GI symptoms were present in 76.7% of subjects with an isodicentric duplication and 87.5% with an interstitial duplication. There was no clear association between GI issues and ASD, with symptoms occurring in 78.9% of all subjects and 78.2% of ASD subjects. The most commonly reported symptoms were gastroesophageal reflux (56.7%) and constipation (60%), with 30% of subjects reporting both. The most common treatments were polyethylene glycol for constipation and proton pump inhibitors for reflux. Behaviors such as irritability and aggressiveness improved with treatment of GI symptoms in several subjects. The results indicate that GI symptoms are common in Dup15q syndrome and may have an atypical presentation. Diagnosis may be difficult, especially in individuals who are nonverbal or minimally verbal, so increased awareness is critical for early diagnosis and treatment.