Implants that induce fibrosis of the Fallopian tubes are a safe and effective means of permanent birth control, a five-year follow-up study confirms.
The study of women who had the Essure sterilization microinserts implanted was done by an independent team of Italian researchers
The findings, published online March 10 in Fertility and Sterility, bolster evidence that the implants are a safe, effective, cost-saving and minimally invasive alternative to conventional tubal ligation.
Nearly half a million women have received a pair of the expanding microinserts since Essure’s FDA-approval in 2002, with the strategy now accounting for about 7% of the sterilization market.
The device consists of a stainless steel inner coil, a nickel titanium expanding, superelastic outer coil, and polyethelene terephthalate fibers. After placement in the fallopian tubes, it causes a fibrotic reaction that triggers tubal occlusion over the course of about 3 months.
The strategy has been shown to be 99.8% effective – better than with laparoscopic tubal ligation or male vasectomy.
“But it would be of no value if it moved, slipped or fell out of tubal area,” said Dr. Hector Chapa, MD, who wasn’t involved in the new research but acts as a medical advisor to Conceptus, Inc., the manufacturer of Essure.
“This is something we have been trying to investigate,” Dr. Chapa, from Methodist Medical Center Dallas, told Reuters Health. “They beat us to it.”
Dr. Mario Franchini, of Palagi Freestanding Unit in Florence, and his colleagues studied 45 women with successful bilateral placement of the devices and occlusion confirmed three months later.
Five years after insertion, there were no detachments or fractures of the devices. In fact, the x-rays looked nearly identical to those recorded at three months post-insertion, based on position, symmetric appearance and distances between the two devices.
“This confirmation of both location and occlusion provides reassurance to physicians and patients,” Dr. Franchini told Reuters Health by email.
He noted placement procedures are minimally invasive and can be performed in an office setting without intravenous sedation or local anesthesia.
Further, Dr. Franchini pointed to a recent review that didn’t reveal any major adverse events associated with Essure. There are, however, three reports of perforations that required removal of the device.
While laparoscopic tubal ligation is also generally safe, it has been linked to potentially life-threatening vascular injuries. Trocar-related vascular injuries may occur in about 0.1% of laparoscopic procedures, according to a 2003 FDA report.
After Essure placement, “patients generally return to normal activities within 24 hours and only experience discomfort comparable to menses,” Dr. Franchini said, adding that “the combined features of in-office use, patient satisfaction and a very high long-term effectiveness rate make Essure a desirable option for women looking for permanent contraception.”
The inserts are now successfully placed about 97% of the time, according to Dr. Chapa, with more achieved on subsequent attempts.
At around $1,300, the procedure also costs less than other permanent birth control options. Traditional tubal ligation typically runs between $3,000 and $7,000.
“I feel this is the future of our discipline: minimally invasive intervention with proven clinical success, all the while minimizing patient risk,” said Dr. Chapa.
Fertil Steril 2011.
— Lynne Peeples, Reuters Health0