What is Essure?
Essure is a permanently implanted birth control device for women, an alternative to having your “tubes tied.” It is a small, flexible coil made of nickel-titanium alloy that is inserted into the fallopian tubes by a medical professional without the need for surgical incisions. Over a period of about three months, scar tissue forms around the device. This build-up of tissue creates a barrier that keeps sperm from reaching the eggs.
The device, approved by the FDA for the U.S. market in 2002, is manufactured by Bayer Healthcare. Originally developed by Conceptus, Inc., which is now a subsidiary of Bayer, the device underwent the FDA’s phase II and Pivotal Study patient testing between November 1998 and June 2001. The device was approved through the FDA’s Premarket Approval process in November 2002.
What is the issue with Essure?
The FDA has been monitoring a growing number of adverse event reports associated with the use of Essure, which include:
- Persistent pain
- Perforation of the uterus and/or fallopian tubes
- Intra-abdominal or pelvic device migration
- Abnormal or irregular bleeding
- Allergy or hypersensitivity reactions
- Surgical removal of the device
In 2015, the FDA held a hearing on the device. That hearing ultimately resulted in a “black box warning” about possible side effects, including persistent pain and allergic reactions.
Black Box Warnings are among the strongest action the FDA takes to warn the public about potential dangers and indicate that a product may cause death or serious injury. The FDA added the warning because it believed “that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically-placed tubal implants that are intended for sterilization.”
FDA Adverse Event Reports. The FDA has reported that over a 15 year period (from its approval in November 2002 to December 2017), it has received 26,773 reports of problems along with reports that the device had become dislodged or broken.
Questions? Our knowledgeable staff is available at (877) 284-6600.
FDA Imposes New Restrictions on Essure Sales
April 9, 2018. The FDA announced that it has restricted the sale and distribution of the Essure device to ensure that any woman considering the use of the permanent contraception device is fully informed of potential risks as they consider permanent birth control options.
Read more on the FDA’s activities.
Potential Essure Side Effects
The Essure device has been associated with severe side effects, including:
- Ectopic pregnancy, pregnancy, and miscarriage
- Uterus and organ perforation
- Device migration into the pelvis
- Chronic pain, vaginal infection
- Heavy bleeding
- Surgeries to remove the device and/or repair internal organs
- Chronic pelvic pain autoimmune disease that includes fatigue, hair loss, rash, weight gain
- Migraines and allergic reaction to the device
According to Drugwatch.com, as of October 2017, Bayer faces about 10,600 lawsuits in the U.S. from women alleging harm from the device. Plaintiffs have had to face preemption laws that make it difficult for them to sue Bayer; however, so far, judges have been allowing these lawsuits to continue for specific counts of negligence.
Many claim that Bayer Healthcare knew of the dangers of the device, including device migration and organ perforation, and concealed this from the FDA, the healthcare community and patients. Others allege that the device was improperly designed and that Bayer misrepresented the safety and efficacy of the device.
Our knowledgeable staff is available at (877) 284-6600.
Receive a Free Evaluation from Attorneys with a Proven Track Record
It can be devastating when the medical device you rely on fails. The makers of Essure promoted it as a safe and effective alternative to other permanent birth control methods yet many are suffering from serious side effects associated with the device.
The Nash & Franciskato Law Firm has a proven track record against medical device manufacturers. Contact us for a free, no-obligation review of your case.
Essure in the News
- FDA Puts new Restrictions on Essure Birth Control Implant [CBS News, April 10, 2018]
- Essure Problems Cost Bayer $413 million last year alone [Modern Healthcare, February 22, 2017]
- California Judge Outlines Next Steps for Coordinated Essure Cases [Modern Healthcare, January 10, 2017]
- Removing Essure Implant Poses New Risks to Patients [Modern Healthcare, November 22, 2016]