Essure—an Intrauterine Device (IUD) manufactured by Bayer AG—was designed to help women avoid pregnancy without the need for invasive laparoscopic sterilization surgery. Approved by the FDA in 2002, Essure is a permanently implanted contraceptive that forms a protective barrier of scar tissue that prevents sperm from reaching the user’s egg.
After the device’s initial approval, over half a million women have chosen to have the Essure IUD device implanted. In the years since, thousands of those unsuspecting women have been permanently and severely injured as a result of the product’s defects.
Essure Linked to Serious Injuries
Bayer marketed Essure as a safe, simple alternative to permanent birth control surgery. However, the implant has been linked to several severe and dangerous side effects. Studies found that women who used the device were 10 times more likely to require revision surgery versus surgical sterilization. The same study found no statistical advantage over laparoscopic sterilization in preventing pregnancy.
The FDA Takes Action
Since 2002, the FDA has received over 5,000 complaints from women using Essure—including many dangerous failures and severe complications, such as:
- Unintended Pregnancy
- Ectopic Pregnancy
- Organ Perforation
- Device Migration
- Severe Cramps or Bleeding
- Vaginal Infection
- Bloating and Fatigue
- Hair Loss
- Chronic Pain
- Unexpected Weight Gain
- Revision Surgery
In 2016, the FDA required Bayer add both a Black Box Warning—something reserved for medical devices that pose a serious or life-threating risk to patients—and Patient Decision Checklist to the product’s label. In 2018, the Agency restricted sale and distribution after learning some women were not adequately informed of associated risks.
Discontinued, Yet Questions Remain
Bayer recently announced they have discontinued the Essure IUD, stating the device will no longer be available for use in the United States after December 31, 2018. In a related press release, Bayer indicated the decision followed declining sales of Essure in the U.S.—and was not based on changes to the product’s risk-benefit profile.
We Can Help
If you or a loved one has suffered due to a defective medical product, call the experienced North Carolina defective product attorneys at Henson Fuerst today at 919-781-1107 or complete a free initial consultation form.
When you call, you will speak with one of our experienced Raleigh, North Carolina Medical Product Attorneys. They will investigate every detail of your situation at no cost to you—and fight hard to protect your rights. At Henson Fuerst, you will never pay an attorney’s fee up front—and you owe us nothing unless we recover for you.