Pharmaceutical industry leader, Bayer, recently announced that it will be discontinuing the sale of its Essure System for Permanent Birth Control at the end of this year. The company insists that the decision is based on declining sales and is not related to reports of adverse incidents and dangerous side effects associated with the product.
The Essure System is the only non-surgical device approved by the Food and Drug Administration (FDA) that offers women a permanent form of birth control. The device is implanted into the fallopian tubes. Scar tissue grows around the device and blocks eggs produced by the ovaries from reaching the uterus, which prevents pregnancy.
In a press release issued by Bayer, the company stands by the product, ensuring women that still have the device implanted that they are safe. According to the company, the benefit-risk profile of the device has not changed, but a decline in sales has limited its profitability. Over the past two decades, interest in this permanent birth control system has declined. Long-acting and reversible contraceptives, and negative press surrounding the product has contributed to the decline in sales.
FDA Imposes Black Box Warning
Much of the negative press generated when the FDA mandated a black box warning label be placed on the product and restricted its sale. Over 16,000 lawsuits have been filed against Bayer for the Essure device claiming injury and dangerous side effects. Perforation of internal organs, bleeding, abdominal pain, depression, autoimmune disorders, and hair loss have been linked to the use of the product.
Lawyers representing women who have charged Bayer with negligence for failing to warn consumers about the risks associated with the product say their chance for success has risen with the recent announcement. The company’s decision increases the odds that punitive damage awards will be added to compensation awarded for medical bills and lost wages.
The FDA has received close to 27,000 reports of adverse reactions to the Essure device. Lawyers representing the plaintiffs in the Bayer lawsuits claim the FDA should have issued a recall of the product when these reports were received. Bayer claims its benefit-risk profile has not changed for the product since it was first marketed.
Bayer insists the benefits of the device far exceed the safety concerns. The company stands behind the product for its effectiveness in preventing pregnancy, but critics argue that the risks involved with keeping the device implanted are too great to justify those benefits.
Highland Park Product Liability Lawyers at the Law Offices of Harold J. Gerr Represent Victims of Dangerous and Defective Products
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