Bayer has finally added a black box warning label to its Essure birth control system per an announcement by the FDA on Nov. 15. The label warns about the risk of serious complications that may be suffered by women. The FDA announcement came only two weeks after the agency issued guidelines for Essure and all permanent hysteroscopically-placed tubal sterilization implants.
Essure is a device designed for non-surgical, permanent sterilization. It consists of two coils made of stainless steel and nickel which are implanted in the fallopian tube during an outpatient procedure. The Essure coils cause scar tissue to form, blocking the descent of eggs and preventing pregnancy.
Many women who received the coils experienced problems including perforation of the uterus and fallopian tubes, pain and allergic reactions to oxides emitted from the metals. The new warning not only informs women of these risks but also the fact that surgery is required for the removal of the medical device if required. The black box warning is the strongest warning that the FDA can require a medical device to carry.
In addition to the warning, a patient checklist will now be provided to women who elect to undergo the implantation procedure. The checklist is designed to ensure that they are aware of the potential problems and side effects.
The new warnings alert women to:
- The permanent and possible irreversible nature of the implant
- The availability of alternative contraceptives
- The effectiveness of the coils and the risk ectopic pregnancy
- Common adverse events
- Long-term risks
- Signs and symptoms that may indicate a problem
Thousands of Essure Complaints
The Essure device was first placed on the market in November 2002. In a recent report the FDA indicated that it had received nearly 10,000 complaints between that time and December 2015.
Those complaints were separated into the following categories
- Abdominal pain – 6989
- Abnormally heavy bleeding or menstrual irregularities – 3210
- Headache – 2990
- Fatigue – 2159
- Weight Fluctuations 2088
- Patient-device incompatibility such as possible nickel allergy – 2016
- Migration of the device or part of the device – 854
- Device operating differently than expected – 490
- Breakage of the device – 429
- Device removal difficulty – 280
- Malposition of the device – 199
- Insertion difficulty – 187
Multiple symptoms were present in many complaints
The FDA also reported that there were four adult deaths attributed to Essure as well as 15 lost pregnancies and two infant mortalities following live births. In addition, there were 631 reports of unwanted pregnancies, 96 of which were ectopic.
Growing Number of Essure Lawsuits
The stronger warnings about the risks of Essure, follow a large tide of lawsuits piling up in state and federal courts across the nation. Similar allegations exist in each case regarding Bayer’s failure to report problems to the FDA, doctors and consumers while being sold to women across the U.S.
It is estimated that 750,000 women worldwide have opted for Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product for $1.1 billion in 2013 from Conceptus, the original developer.
The size of Essure litigation against both Bayer and Conceptus is expected to grow significantly as defective medical device lawyers continue to review cases.
Sibley Dolman Gipe Accident Injury Lawyers, PA is a Florida personal injury law firm, currently seeking women who believe they have been hurt by the implantation of the Essure birth control system. If you believe you are one of those women, our Essure injury lawyers would love to speak with you. Call today and make an appointment for a free, confidential consultation with a qualified attorney at 727-451-6900. You may be entitled to compensatory damages.