Essure safety a high-priority issue, says FDA
Establishment of a patient registry, collection of clinical and bench data, and changes to labeling were among the postmarket measures discussed by an expert panel convened by the Food and Drug Administration (FDA) on September 24 to weigh the benefit/risk profile of Essure. The session, which brought together representatives from the National Institutes of Health, the device’s manufacturer, women’s health experts, and patients, was triggered by a dramatic increase in voluntary adverse events reports about the contraceptive implant.
Essure is a spring-like device that is placed in the proximal section of each fallopian tube lumen. The in-office procedure is performed under hysteroscopic guidance. According to testimony from the manufacturer at the meeting, an estimated 1 million such implantations have been performed worldwide, the majority of them in the United States following its approval for marketing in 2002.
The product was approved by the FDA based on 2 prospective clinical trials performed by the sponsor and reviewed by the agency and its Obstetrics and Gynecology Devices Advisory Panel. The manufacturer was required to continue gathering data from patients in ongoing Phase II and Pivotal studies out to 5 years after discontinuation of alternative contraception and to conduct a new study documenting the bilateral placement rates for newly trained physicians.
Since 2004, more than 5,000 Medical Device Reports (MDRs) about Essure have been submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, the majority (4,439) between 2013 and 2015. Of the complaints, 3,516 have been about abdominal or pelvic pain and/or cramping, 1,580 about bleeding irregularities, 878 about allergy/hypersensitivity, 337 about pregnancy, and 227 about migration of the device outside the uterus.
The panel convened by the FDA was asked to review and discuss data presented by the agency, manufacturer, and members of the clinical and patient communities and specific safety events and potential risk mitigation steps. They also considered possible collection of additional preclinical or clinical data and offered their perspectives on Essure’s overall risk/benefit profile.
Although the panel issued no formal conclusions, the members expressed the potential need for:
· Changes to the device’s labeling to make clear that Essure is a permanent implant
· Additional patient counseling around the nature of the implantation procedure and the benefits and risks of the device;
· Additional training for physicians on how to insert and remove it;
· More long-term data on patient outcomes with Essure;
· An “early intervention” protocol for patients with implants who may be experiencing adverse effects; and
· Bench testing and development of a patient registry to help resolve questions about adverse events in Essure users, such as hypersensitivity issues.
In preparation for the meeting, the agency created a docket for public comment on Essure, which will remain open until October 24. All interested parties are encouraged to submit comments for consideration by the Agency to http://www.regulations.gov.
Said an FDA spokesperson in summing up the proceedings, “Over the past 2 years, the agency has become aware of a growing number of safety concerns with Essure from women and physicians. The FDA considers this to be a high-priority issue and will inform the public about next steps.”