Over the years, women’s health advocates have applauded advances in birth control options, from the pill to tubal ligation. But as with any medical advancement, such options come with attendant risks, especially when surgery is involved. And until recently, women seeking a permanent fix had no choice but to get their tubes surgically tied.
Today, women looking for permanent birth control options have a surgery-free alternative with Essure, a device that can be inserted by a catheter. But this option is not risk-free. According to the U.S. Food and Drug Administration, health and safety concerns about this product have markedly increased this year. The FDA has received almost 1,000 complaints about Essure since it became available to women. Half of those complaints came in 2013.
How Essure Works
During the 10-minute procedure, a doctor places the Essure inserts – which are similar to heart stents and are made out of soft, flexible materials – into the woman’s fallopian tubes. Essure works with the body to form a natural barrier that prevents sperm from reaching the egg. However, it takes three months for Essure to take effect, so women should continue taking another form of birth control until their doctor confirms it is safe to rely solely on the device.
Problems Associated with Essure
The most common complaint stemming from Essure implantation is pain, which the manufacturer lists on the product label as a possible side effect. Some women have also experienced extreme fatigue, weight gain and depression, which are not listed on the label. Other reported side effects include hemorrhages, headaches and menstrual irregularities. Additionally, women have reported problems with the device itself, such as migration, incompatibility, malposition, nickel allergy and breakage.
The FDA reviewed these complaints and the available information but concluded that the reported complications do not indicate new safety issues with the device. Moreover, officials found no causal connection between Essure and the complained-of fatigue, weight gain and depression. Women health advocates dissatisfied with the FDA’s conclusions have called for more clinical studies. They argue that women need more information about potential long-term risks of using Essure. Indeed, the more women who experience complications using Essure, the greater the need to better understand health and safety risks.
In the meantime, doctors should make women aware of Essure’s recognized warnings and precautions, including:
· The possibility of the doctor failing to place the inserts correctly;
· The rare possibility that part of the insert could break off;
· The rare possibility that the insert could puncture the fallopian tube;
· The possibility that the woman’s body will absorb much of the salt-water iodine used during the implantation;
· That women in the second half of their menstrual cycle should delay having the procedure;
· That women who undergo the procedure and still get pregnant are more likely to have an ectopic pregnancy; and · That after the procedure women might experience pain, cramping, vaginal bleeding, pelvic discomfort, back discomfort, nausea, vomiting, and/or fainting.
These are only some of the risks associated with using Essure. For more information, consult your doctor. If you suspect medical malpractice, contact our attorneys today.