The U.S. Food and Drug Administration has approved transvaginal ultrasound use to confirm that the Essure birth control implant has been properly placed.

The ultrasounds should help ease the minds of physicians and patients that the contraceptive implant can be relied on for effective birth control and that the metal coils haven’t migrated to other organs or caused any other potentially life-threatening complications.

Transvaginal ultrasounds will replace the current method of confirming Essure placement which relied on x-ray use of the uterus and fallopian tubes. The ultrasound will use sound waves to form an image of the area and can take place in a doctor’s office.

What is Essure?

The contraceptive implant Essure provided an alternative to tubal ligation surgery which was considered a medical breakthrough when it became an option 13 years ago. Essure was marketed as a permanent birth control method for women who wanted to be sterile but did not want to undergo surgery.

The birth control implant Essure was an attractive option for hundreds of thousands of women as the product claimed to last a lifetime but only required a 10 minute procedure that could be done in a doctor’s office. A permanent birth control option that required no surgery or recovery time made Essure a very popular option for many women.

Manufacturers claim the birth control product works by inserting two coils made of metal and polyester through the vagina and uterus and placing them inside each fallopian tube. Once the coils are implanted, scar tissue develops around them which in turn blocks the fallopian tubes and prevents insemination.

Physicians urge patients to avoid solely relying on the contraceptive implant until about three months, as that’s about how long it takes to develop adequate scar tissue around the Essure coils.

Bayer estimates nearly 750,000 Essure birth control implants are used around the world.

Contraceptive Implant Complications

Since its release on the U.S. market, the FDA has received more than 5,000 adverse event reports that claim the Essure birth control implant caused multiple complications.

Some of the reported Essure complications include:

• Organ perforation
• Excessive menstrual bleeding
• Abdominal pain
• Severe back and pelvic pain
• Weight fluctuation
• Bloating
• Allergic reactions
• Headaches
• Fatigue
• Miscarriages
• Ectopic pregnancy

Some women who have filed Essure lawsuits claim the implant migrated into the uterus which required a hysterectomy. Essure has also been named in at least four deaths as well.

The FDA has decided to set up an advisory committee meeting in September to determine if any Essure safety issues need to be addressed.

Essure Lawsuits

Multiple Essure lawsuits have been filed by women who claim the birth control implant caused severe, long-term complications. Some plaintiffs allege that Essure manufacturer Bayer fraudulently concealed adverse reports and documented migrations and perforations from the FDA as well as consumers.

Other Essure lawsuits allege Bayer is in breach of advertising, marketing, and website warranties based on the following claims: Zero pregnancies in clinical trials – plaintiffs alleges there were four pregnancies during trials; Surgery free – plaintiffs claim all Essure procedures are performed under hysteroscopy, which is a surgical procedure.