Bayer HealthCare Pharmaceuticals Inc. will have another product in the intrauterine device market even as the corporation deals with lawsuits related to increased health risks posed by an existing Bayer IUD.
Bayer announced Jan. 9 that the U.S. Food and Drug Administration approved its Skyla intrauterine system “that is placed in the uterus for the prevention of pregnancy for up to three years.” Skyla’s introduction overlaps the filing of Mirena IUD lawsuits by women who assert that their injuries stemmed from using the latter Bayer intrauterine contraceptive.
Injured plaintiffs in Mirena IUD lawsuits have reported severe adverse reactions, including:
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
- Embedment of the device in the uterine wall
- Perforation of the uterine wall or cervix
Mirena IUD labeling has been updated through the years to keep users and medical professionals apprised of new information dealing with precautions and with patient populations for whom the product is indicated.
Bayer’s Frequently Asked Questions, in regard to the Mirena IUD, address PID as follows: “If not treated quickly and appropriately, PID can lead to serious problems, including infertility, ectopic pregnancy or constant pelvic pain. Serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed…”
The manufacturer also describes sepsis as a “rare life-threatening infection”; it explains that uterine embedment diminishes Mirena’s contraceptive properties; and it cautions, “If your uterus is perforated, Mirena may no longer prevent pregnancy. It may move outside the uterus and can cause scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed.”
The rarity of an adverse reaction does not negate the unreasonableness of a patient’s increased risk of experiencing it, which is the reason that a woman who has used the Mirena IUD and who has suffered any of the aforementioned Mirena side effects may be entitled to compensation.
The Mirena IUD attorneys at Reich & Binstock can help such victims. Upon request, an experienced pharmaceutical injury lawyer at Reich & Binstock will evaluate the circumstances and discuss the legal options with a Mirena patient. This legal advice does not cost anything. The consultation is free.
Reich & Binstock, which operates in all 50 states, may be reached either through the electronic form on its Web site, www.reichandbinstock.com, or toll-free at 1-866-LAW-2400.
Bayer has addressed increased risks in Skyla by noting rare adverse reactions that surfaced in Skyla’s clinical trial, “including ectopic/intrauterine pregnancy, life-threatening infections, pelvic inflammatory disease (PID), perforation, and expulsion,” as the corporation’s new-product announcement reads.