FDA Issues Black Box Warning on Essure Birth Control Devices

Warnings on Birth Control DeviceWomen looking for a simple alternative to traditional methods of sterilization have turned to the Essure Permanent Birth Control System, which is marketed and sold by Bayer. The contraceptive device was originally developed by Conceptus Inc. and approved in 2002. Bayer purchased Conceptus and the rights to the Essure System in 2013 and is now under fire for numerous complications that women using the system have suffered. These complications are so severe that the FDA has implemented a black box warning for the devices— which requires patients to sign a waiver stating that they have been notified of the risks associated with the devices prior to use.

How the Essure System Works

The Essure Permanent Birth Control System is a non-hormonal birth control method that prevents pregnancy through sterilization. Two flexible coils are inserted into the fallopian and over time, scar tissue develops around the coils and causes permanent infertility by creating a barrier that prevents eggs from reaching the uterus. The simple outpatient procedure has made the system an attractive alternative to tubal litigation and the devices can be inserted without any need for anesthesia.

Tubal litigation requires small cuts and general anesthesia, but the fallopian tubes are burned, cut or clamped rather than being blocked with scar tissue. This traditional method may have fewer complications, however, and thousands of women claim that they were never warned about the risks prior to electing to use the Essure system.

Severe Physical Pain, Emotional Damage and Death

Among the complications that were cited in numerous complaints, women stated that the devices caused extreme pain, neurological damage, perforation of internal organs and death. The severity of the complications inspired the boycott of the device by women’s activist groups in the form of a hunger strike outside of the FDA’s headquarters when the government body refused to pull the devices from the market.

Instead of issuing a complete ban, the FDA is allowing the sale of the devices under black box rules. While it is true that women are now required to indicate that they are aware of and accepting of the risks associated with the devices before electing to undergo the procedure, advocates of a ban question whether all of the risks are being communicated effectively and feel that the devices are a threat to public health and safety.

The complications and injuries that have been associated with the Essure Permanent Birth Control System include the following.

  • Perforation of the fallopian tubes. The coils used in this procedure are composed of stainless steel, nickel titanium and polyethylene fibers. Women have reported that the coils have perforated the fallopian tubes, causing internal bleeding, swelling, infection and severe pain.
  • Migration of the device. Some victims have reported that the coils migrated to other organs, causing internal damage, infections and severe pain.
  • Fluid buildup. While extremely rare, some patients experienced buildup of fluid in the blood classified as hypervolemia. This is a serious condition that requires medical attention.
  • Device rejection. If the body rejects the device, there may be an autoimmune response that causes pain and tissue damage. The removal of the device to address these issues could place the victim at a greater risk of developing uterine cancer.
  • Neurological complications. Some patients have reported lightheadedness, migraines and other neurological concerns linked to the Essure system.
  • Sexual dysfunction. The pain and suffering caused by these devices can impact sexual performance and make intercourse painful and unpleasant. This can lead to emotional anguish and embarrassment in addition to the sexual dysfunction. Couples have claimed loss of consortium when the woman is no longer able to maintain a romantic relationship with her partner due to injuries caused by the device.
  • Hysterectomy. In some cases, victims must undergo hysterectomies to address the complications suffered due to the Essure system. This can lead to additional complications such as pelvic organ prolapse, incontinence and bowel dysfunction. Women undergoing hysterectomies may also be at an increased reach of developing cancer.

Women Seek Damages from Essure’s Manufacturer

Many women still feel that the FDA has not gone far enough to prevent the injury of thousands of women in the future who choose Essure as a form of birth control. Over 5,000 women have come forward with complaints so far and many more complaints are expected as victims begin to seek compensation for their injuries. If you have suffered injuries that you feel are linked to the Essure Permanent Birth Control System, it is important that you know your rights and legal options before deciding how to move forward with your claim.

Rosenfeld Injury Lawyers LLC offers award winning legal services to thousands of women just like you across the country and would be happy to review your case free of charge. If you have any questions about the legal process and what you may be able to expect if you file legal action, contact us today to learn more.