Bayer Faces Lawsuits Over Essure Birth Control Injuries
Women often have limited permanent birth control options, and other than one option, they are all involving surgery. Surgery itself has risks for the patient, as well as recovery times and pain. Needless to say, the need for nonsurgical birth control is wildly popular and would be very lucrative.
Essure, which was developed by Conceptus, Inc, is an implanted sterilization technique that does not require surgical intervention. Conceptus was bought by Bayer AG in 2013, and now is a division of Bayer AG, a German chemical and pharmaceutical firm. Therefore Essure is now owned by Bayer AG. The process of vetting for Essure is as follows:
- In November 1998 until June 2001, it went through FDA testing, Phase 2, and Pivotal Study Patient Testing.
- Essure passed FDA Premarket Approval in November of 2002. It has been on the market in the US since that time.
Essure is a device that, using two coils, is placed into the fallopian tubes to block the sperm from reaching an egg, by a specially trained doctor. It is a non-surgical procedure, with then avoiding the risks of surgery complications. The implanted coils are made from nickel, which some people have sensitivities to. Essure must also be removed by a doctor and it is unclear what parameters are required to determine if the device should be removed.
From the time of FDA approval in 2002, to May 2015, there have been nearly 5,100 reports of birth control device injuries.
- five fetal deaths when birth control device failed and pregnancy resulted
- a total of eleven deaths were reported because of:
- complications of uterine infection after the device moved within the body
- uterine perforation after the device moved within the body
- blood clots after surgery to remove device as well as additional injury during attempted removal
- Injuries from movement of device
- punctures of fallopian tubes when coils moved
- punctures of uterus when coils moved
- ongoing abdominal pain
- extreme fatigue
- allergic reactions to the nickel used in the device
- severe muscle weakness
- reduced bowel control function
- autoimmune disorders
- adhesion disorders within the uterus and fallopian tubes
- unclear long term risks
According to the lawsuits, Essure birth control devices were not tested in double blind studies, were not tested in randomized studies, and no use of comparison study participants happened in the studies. The allegations state that this data from appropriate testing would have given more information on potential risks and side effects, but this data was hidden from the FDA in the approval process. According to a Bayer employee, the company received 15,000 complaints of adverse events but did not address this information.
- Heather Walsh filed a suit in July2014, alleging that Essure did not provide adequate information to consumers, misleading them on the safety of the device, and that FDA approval conditions were violated. The suit was filed in Philadelphia civil court, against Bayer HealthCare. According to court records, Ms. Walsh’s injuries included a punctured fallopian tube with resultant 5 hospital stays, a hysterectomy, autoimmune and adhesion complications, due to three, not two Essure coils being utilized in the procedure.
- The FDA called a meeting of the Obstetrics and Gynecology Devices panel in 2015, to hear reports from women who had utilized the Essure birth control device.
- November 2015 saw a bill introduced in Congress by Congressman Mike Fitzpatrick (R-PA), titled “EFree Act” which would mandate the removal of Essure from the market in the US by the FDA. In the bill itself is stated, “If the FDA and the manufacturer of the device aren’t willing to remove this device from the market, then Congress will.” The bill would also require that Essure be pulled from the market by the FDA.
- February 2016 the FDA ordered that a warning label be placed on all Essure labels, called a “black box warning”to educate consumers on the potential life threatening health risks. The Agency also demanded that this device be tested in “a real-world environment” to assess the risks and possible complications in women who are currently using Essure. The Agency will then “determine what, if any, further actions related to Essure are needed to protect public health”. Bayer is to follow more than 2,000 Essure users for no less than three years.
- On March 20, 2016 a judge in Pennsylvania has allowed a lawsuit by five women against Essure to continue in court cases. Some of the claims were dismissed, labeled “preemption”, the allegations of fraud due to misrepresentation was dismissed as well. However, the negligent misrepresentaion claim was allowed. It was also determined that though the companies in question (Bayer and Essure) had premarket approval from the FDA, this did not prevent lawsuits on other claims. The court case continues. More patients are added into cases as negative health outcomes come to light.
- Essure continues to be available for purchase, and neither the FDA nor Bayer have removed it from the market. Lawsuits state that physicians and consumers are not aware of the dangers of the birth control.
Essure is marketed as a permanent birth control option. At this point, other permanent options include: hysterectomy, tubal ligation, tubal fulguration, salpingectomy or clip application. Essure is a non-surgical option unlike the other options currently available. Essure can be removed, however it is alleged that doctors are not trained in appropriate and safe techniques to remove it, and injuries have resulted from attempted removals.
It has been recommended that potential users of Essure be tested for a nickel sensitivity, and if they have a history of allergy or test positive for nickel sensitivities, should not be implanted with Essure. Also patients who have known autoimmune disorders should not use Essure. If a patient has had chronic inflammation or a history of uterine surgery, then the use of Essure is contraindicated. It is also recommended that physicians should have significant added education for the ability to remove Essure safely.