When Essure first debuted on the market in 2002, the media hailed it as the least invasive form of permanent birth control possible. Until Essure became available, the only option for permanent contraception was tubal ligation, which can only be done through an invasive surgery. Of course, some women who underwent treatment with Essure went on to experience complications ranging from pain to damage to internal organs. In California, as in other states, people who suffered injuries as a result of Essure have filed product liability lawsuits against Bayer, the company that makes Essure.
What is Essure, and How Does it Work?
Essure is an insert made of polyester fibers, nickel, and titanium, surrounded by coils. When inserted into the fallopian tubes, it causes fibrosis, leading to blockage of the tubes and therefore preventing pregnancy. Unlike tubal ligation, which must be done in a hospital and with general anesthesia, Essure is a much simpler procedure, not much different from inserting an intrauterine device (IUD). Promotional materials for Essure claimed that it only takes seven minutes to insert the device, and the procedure can be done on an outpatient basis, by the same OB/GYN doctors women see for all concerns related to reproductive health. The effects of Essure are permanent; removing the device and reversing its contraceptive effects is more complicated than reversing a tubal ligation. At least in theory, the only way a woman who has undergone Essure treatment can become pregnant is through in vitro fertilization (IVF).
Product Liability Lawsuits Related to Essure
Many women who had had Essure devices inserted experienced complications. For example, some women required hysterectomies because of severe bleeding and pain. In other cases, the devices became dislodged from the patients’ fallopian tubes and damaged other organs. The lawsuits related to Essure are product liability lawsuits against Bayer. In other words, the plaintiffs’ injuries are the result of Bayer’s negligence in manufacturing and in marketing the device. They are not medical malpractice lawsuits because the physicians who inserted Essure were installing it in the safest possible way and made sure that the patients were good candidates to use Essure rather than other forms of birth control.
Bayer has received several citations from the FDA because of adverse events related to Essure. For example, it has been cited for having Essure made in unlicensed factories and with unapproved materials. Since November 2016, the FDA has required that Essure bear a black box warning detailing the risks associated with the device. Since April 2018, doctors who prescribe Essure must first go through a checklist of questions and warnings with patients before they insert Essure.
Contact Case Barnett About Product Liability Cases
If you have been injured as a result of Essure or another medical device, you could have grounds for a personal injury lawsuit. You could receive compensation for your medical expenses and lost income. Contact Case Barnett in Costa Mesa, California to discuss your case.