Women’s Contraceptive Implant Faces New Restrictions by FDA

The relatively new permanent contraception implant option, Essure, is facing new restrictions in its use from the U.S. Food and Drug Administration due to reports of complications that have been linked to the use of the implant. The FDA news release stated that the new restrictions are in place to make sure women “are provided with adequate risk information so that they can make an informed decision.”

How Does Essure Work?

Essure is a type of birth control implant that does not require surgery to insert. The device consists of flexible coils, which are inserted by a doctor through the vagina and cervix until it is in the fallopian tubes. The implant causes tissue to build up and form around the fallopian tubes, which are responsible for carrying eggs to the uterus. The tissue prevents sperm from reaching the egg and prevents pregnancy.

Side Effects

There have been 26,773 complaints since Essure was approved in November 2002. It has also been linked to eight deaths. The list of other serious complications include:

• Migration of the implant into the pelvic or abdominal cavity
• Frequent and constant pain, perforation of the uterus or fallopian tubes
• A hypersensitive or allergic reaction to the device itself

Additionally, less serious side effects have been reported, however, it hasn’t been confirmed that these side effects are directly caused by using birth control. These side effects include:

• Depression
• Fatigue
• Weight gain
• Mood changes
• Hair loss

What is Prompting the New Regulations on Essure?

The problem is that many of the women who suffered from these complications were not fully informed about the risks of the implant, even after “significant efforts to educate patients and doctors about the risks associated with this device.” The agency has decided that health care providers are responsible for going over a brochure about Essure and explaining the benefits, risks, and details associated with using this method of birth control. Both the patient and physician must sign an acknowledgment that this information was properly communicated.

Previous Round of Regulations on Essure Wasn’t Enough

This isn’t the first time the FDA has imposed restrictions on Essure. Bayer, the maker of the device, was instructed to add a warning to the box and decision checklist, which reduced sales by 70 percent. Bayer is required to comply with the new regulations effective immediately. They are also responsible for ensuring that patients receive the information and for requiring health providers to comply.

FDA Empowers Patients to Make Informed Decisions

Bayer responded by stating that the reviews by the FDA have ruled that the device is “safe and effective.” Dr. Mitchell Kramer, who is the director of the obstetrics and gynecology department at Huntington Hospital in Huntington, NY feels that the move will be helpful to women. He stated that this is the FDA’s “way of assuring that patients understand exactly what potential complications and problems can occur” when choosing to use Essure for permanent birth control. He also added that there are pros and cons to all procedures and that the most important thing is to inform patients and providers with as much information as possible to allow them to make an educated decision.

Resources:

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm