Essure Birth Control Lawsuit Filed Against Bayer Healthcare
Women who receive an Essure birth control implant for pregnancy prevention may be at risk for side effects like device migration and perforation of internal organs.
Back in July, the first lawsuit was filed against Bayer Healthcare over side effects allegedly caused by its birth control device Essure, and many more complaints are expected to be brought against the medical device maker in the coming months, as more information comes to light about the risk of Essure complications. The first Essure lawsuit, filed in Philadelphia civil court on behalf of Heather Walsh, accused Bayer of intentionally misleading women who received an Essure implant, and violating the conditions upon which the device maker received premarket approval from the FDA for its birth control product. If you received an Essure implant, and you have since suffered complications like device migration or organ perforation, our consumer advocates at the Leading Justice can help put you in touch with an experienced Essure attorney today.
Potential Side Effects Tied to Essure Birth Control
Essure is a permanent birth control system featuring two small metal coils that are implanted in the fallopian tubes, and is designed to prevent pregnancy by promoting scar tissue growth in and around the implant. Heather Walsh, who received an Essure implant for pregnancy prevention, subsequently experienced migration of the device out of her fallopian tubes, leading to five hospitalizations, a hysterectomy to remove the defective device, and the development of auto-immune and adhesion disorders. The safety of the Essure birth control system was first brought into question last year, when thousands of women began to come forward to talk about the complications they experienced after receiving an Essure implant, including excessive bleeding, bloating, rashes, and chronic pelvic pain, as well as miscarriages and ectopic pregnancies.
Bayer “Actively Concealed” Side Effects of Essure
Serious concerns have been raised recently about the safety of the Essure birth control system, and even famed consumer advocate Erin Brockovich has raised questions about the premarket approval the device received from the FDA, which allowed Essure to enter the market for consumer use. “[Bayer] got premarket approval for studies that could clearly be questioned,” argues Brockovich, concerns that were also raised in Walsh’s Essure lawsuit. According to Brockovich’s claims, Bayer “actively concealed” adverse side effects of Essure from the FDA. In most cases, premarket approval guards a company against any product liability lawsuits, but Walsh’s complaint alleges that Bayer broke the conditions for the premarket approval by withholding important side effect information, thereby rendering the Conditional Premarket Approval “invalid” and the device “unadulterated.”
Contact a Qualified Essure Attorney Today
According to Bayer, approximately 750,000 women have received an Essure implant since it was approved by the FDA in 2002. In light of the risk of serious side effects from Essure, Bayer recently added warnings to the product label, and the FDA conducted a review of the adverse events reported in connection with the birth control device. According to the agency’s findings, close to 1,000 women have reported cases of complications related to Essure in the past ten years, including 150 complaints of the coils breaking or misfiring, 91 reports of women requiring hysterectomies to remove the device, 80 reports of women becoming pregnant on Essure, and other reports of complications involving Essure migrating out of position or puncturing internal organs. If you believe you have been adversely affected by side effects of Essure, contact a knowledgeable Essure lawyer today to discuss your legal options.
[box type=”note” align=”aligncenter” ]Source: http://www.abc15.com/news/local-news/investigations/first-lawsuit-filed-against-fda-approved-essure-permanent-birth-control-bayer-healthcare[/box]