The FDA has announced a public meeting of its Obstetrics and Gynecology Devices Panel in September 2015 to discuss newly discovered, painful side effects linked to Essure contraceptive. Since its approval date of November 2002 through May 2015 the FDA has received 5,093 potential cases of device-related safety issues with more women currently coming forward with complaints. However, Essure is sold in at least 23 countries and has been implanted into 750,000 patients.
Some of the side effects that are not mentioned in the literature associated with this device are weight gain, extreme fatigue, depression, heavier menses/menstrual irregularities, and abdominal pain. These side effects were not common in the original clinical trials associated with this device after it was implanted.
The most frequent issues seem to occur with the Essure device itself, with reported problems of incompatibility with the body due to a possible allergic reaction to the nickel. Among the possible allergic reactions, there are reports of damage to the device such as pieces becoming unattached and ending up in the abdomen as well as positioning problems as the device moves from its original implantation site.
Clinical trials are conducted prior to the release of new pharmaceutical products to determine possible side effects related to the drug or medical device being released. Even though the results of the trials are thoroughly documented, there are uncontrollable risks involved when altering the human body. It has recently come to light that the permanent contraceptive known as Essure is linked to painful and possibly damaging side effects.
The clinical trials conducted by Conceptus, the original manufacturer of Essure, consisted of PAS, Post-Approval Studies. These studies focused on five-year follow-up information from women who were previously implanted with the permanent contraceptive. The company was mainly concerned with the effectiveness of the birth control, safety of the procedure, and safety of the device after implantation. In June 2013, Bayer Healthcare company purchased Conceptus and revised the patient information brochure to state that Essure may relocate into the abdomen and cause chronic pain as a rare side effect.
Temporary forms of contraceptive such as the use of condoms, diaphragms, or birth control pills are often not as reliable as permanent contraceptives. There seems to be not as much concern about unplanned pregnancies, taking hormones to control the ovulation period, or missing a dose of the medication. Permanent birth control options are more effective when a woman is no longer interested in having children.
If the male in the relationship offers to undergo permanent contraceptive he will need surgery to perform a Vasectomy. This procedure involves cutting, sealing, or tying off the vas deferens to stop the production of sperm from entering a woman through ejaculation.
Women who decide to seek information regarding permanent contraceptive often speak to their OBGYN. One option, known as Tubal Ligation, involves surgically closing the Fallopian tubes either by burning or blocking them with a clip. This procedure must be performed in a hospital setting due to the use of laparoscopic equipment or needing to make a small incision into the abdomen. Essure is the only form of permanent contraceptive that does not involve invasive surgery since the procedure can be performed in the physician’s office without the use of anesthetics.
Essure is considered a Fallopian tube occlusion, meaning that the fallopian tubes are blocked by small pieces of coil-shaped metal which are inserted into each tube. During the course of about three months, the body forms a natural barrier around the coils blocking sperm from entering the tubes.
Even though the painful side effects linked to Essure are still being investigated, the procedure is a less invasive approach to permanent birth control. Women should educate themselves regarding all available options before making the decision to become permanently sterilized. This subject should be carefully thought through and discussed with the proper physician.
By Deborah Narimanidze
FDA: Medical Devices-Essure Permanent Birth Control-FDA Activities
NY Times: Long-Term Data on Complications Adds to Criticism of Essure Contraceptive Implant
Healthy Women: Permanent Birth Control; Understanding Your Options
Chicago Tribune: Women Report Complications From Essure Birth Control
Inside Photograph Courtesy of Shandi-lee Coxs’ Flickr Page- Creative Commons License
Featured Photograph Courtesy of James Palinsad’s Flickr Page – Creative Commons License