July 7, 2015 - The FDA announced last week it will take a new look at the safety of the permanent birth control implant Essure, after a dramatic rise in the number of side effects reported by patients.
Essure is a small flexible metal coil that is implanted in the fallopian tubes through the cervix and uterus in a non-surgical procedure called hysteroscopic sterilization. Within three months, scar tissue grows around the device, blocking the production of new eggs.
The maker of Essure, Bayer, states that more than 750,000 women have undergone hysteroscopic sterilization with the device so far. They also claim it is nearly 100% effective. However, recent reports raise questions about the product’s safety and effectiveness.
One of the main concerns is the recent and sudden rise in the number of complaints from those who have received the implants.
Essure was approved by the FDA in November of 2002. From that time, until October 25, 2013, the FDA received fewer than 950 reports of side effects.
Then, in just the few years from October 26, 2013 through the present, reports of patient side effects spiked to over 4,150. That means 81% of the complications occurred within the past several years.
Experts aren’t sure what the reason could be for the rise. Although Essure was shown to be safe in several post-approval tests, this could be an indication that the device carries more long-term risks that didn’t surface in early studies.
Some of the most serious side effects reported by women who received Essure implants are movement of the devices from the fallopian tubes, tearing of other internal organs, and surgery needed to remove the migrated devices. A few reports even mentioned patient death.
However, the most commonly reported problems with Essure are:
- Pain (3,353 patients)
- Heavy or irregular menstruation (1,408)
- Headaches (1,383)
- Fatigue (966)
- Metallic allergy (941)
- Weight gain (936)
- Device dislocation (482)
- Device breakage (259)
- Misplacement of device (133)
In most of the reports to the FDA, patients noted experiencing more than one of these side effects.
In response to the rise in Essure complaints, and concern from citizen groups, the FDA announced on June 24th that its Obstetrics and Gynecology Devices Panel will conduct a review over the product’s safety and effectiveness on September 24th.
This hearing will also look into the potential long-term complications of Essure after 5 years.
In response to the news, Bayer stated it "looks forward to an open and transparent discussion regarding Essure" in September.
Last year, a study from Yale University found that sterilization procedures involving Essure are less effective than traditional tubal ligation procedures.
Bayer claims that Essure is 88.83% effective at preventing pregnancy. However, researchers discovered that as many as 9.6% of women might get pregnant within a decade of have the deice implanted.
They noted that the effective rate claimed by Bayer is dependent upon a “perfect insertion,” which rarely occurs. Instead, there are a host of things that can go wrong during or after the implant procedure.
By comparison, the Yale researchers found that Essure patients were four times as likely to get pregnant than those women who underwent traditional laparoscopic tubal ligation.
Unfortunately, Essure was approved under an FDA provision that prevents patients from filing lawsuits for personal injury. However, this is currently being challenged in court.
DrugNews will continue to chart the safety and effectiveness of Essure, and provide any updates on new studies and the rights of those affected to file legal claims.
Sources:
Lowes, R. Essure Adverse Events Ballooned Since Late 2013, FDA Says. MedScape. (June 24, 2015). Retrieved from http://www.medscape.com/viewarticle/846990
Lawrence, S. FDA panel slated to weigh Bayer Essure safety after more than 5,000 complaints FiercePharma. (June 25, 2015). Retrieved from http://www.fiercemedicaldevices.com/story/fda-panel-slated-weigh-bayer-essure-safety-after-more-5000-complaints/2015-06-25
Gariepy, A. Probability of pregnancy after sterilization: a comparison of hysteroscopic versus laparoscopic sterilization. Contraception Journal. (March 2014). Retrieved from http://www.contraceptionjournal.org/pb/assets/raw/Health%20Advance/journals/contra/CON-8309-FINAL.pdf
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