Complaints are beginning to rise among the nearly 1 million women who have been implanted with a medical device intended for contraception. The woman say the device, named Essure, can cause extreme pain, bleeding and damaged tissue. Many have had to endure numerous surgeries in order to have the devices extracted. Some – including young women – have had to undergo hysterectomies, allegedly as a result of complications caused by these devices.
Unfortunately, patients who used the device are finding it difficult to pursue litigation. The company that produces the device, Conceptus, was purchased by Bayer HealthCare early last year. Due to a medical device amendment passed by Congress, devices such as this that won pre-market approval from the U.S. Food & Drug Administration may not be subject to common law claims. The amendment even withstood a challenge in the U.S. Supreme Court.
So even though the FDA approved the device after a small study of just 500 women, victims may have little options for recourse unless they can show doctors weren’t sufficiently trained by the manufacturer to implant the product, or the maker broke federal law in some regard.
In response to some of the complaints, manufacturer revised possible side effect list to include possible chronic pelvic pain.
But Essure isn’t the only contraception with which many women have had problems in recent years. In cases where women have been prescribed brand name medications, as opposed to generic drugs or medical devices, our product liability attorneys know claims for damages/compensation may be more straightforward.
Yaz, for example, is a newer generation of “the pill” that contains a hormone called drospirenone, which in recent years has been associated with numerous reports of gallbladder disease, pulmonary embolisms, blood clots, strokes and even deaths. This product as well is owned by Bayer Healthcare, which in 2013 settled 6,800 claims for $1.4 billion. That settlement agreement did not require the company to admit fault, and the drug is still being prescribed to women across the country.
While there have been numerous calls to the FDA to issue a recall, that has not happened. The federal regulator did, however, order a revised label for all contraceptives containing drospirenone, flagging users for being at three times’ higher risk for blood clots. Of course, that information is buried on page 5 of a 33-page document for the drug.
Drug safety advocates at the very least want a stronger black-box warning, but thus far, that has not happened.
Another potentially dangerous birth control drug is the NuvaRing, which is reported in some cases to have an increased risk of blood clots, stroke and heart attack. In some cases, women have reportedly died after suffering pulmonary embolism or deep vein thrombosis.
The device is a small, flexible ring designed for monthly insertion into the vagina. Over the course of three weeks, it releases controlled amounts of hormones intended to prevent pregnancy. One of those hormones, etonogestrel, has been linked to a number of major health concerns, and the NuvaRing delivers a relatively high dose of it. In fact, studies have shown users of this contraceptive may be at 6.5 times greater risk of suffering venous thrombosis as compared to women who use older generation birth control products.
The Ferraro Law Firm handles claims resulting from defective medical products or dangerous pharmaceuticals. Offices in Miami and Washington, D.C.