Product News and Recalls

Regulators approve Bayer IUD

The U.S. Food and Drug Administration has approved Skyla, an intrauterine device manufactured by Bayer.

A Reuters report describes Skyla as a T-shaped polyethylene device that releases low doses of the hormone progestin, and is designed to prevent pregnancy for three years. It’s the first new device of its type to be approved in 12 years.

Recently, Bayer has had problems with other birth control products.

Last year, the company spent $750 million to settle nearly 3,500 lawsuits alleging that its Yasmin line of birth control pills caused blood clots. An estimated 8,800 more lawsuits over the pills remain to be settled.

While all birth control pills can increase the risk of blood clots, studies have shown that Yasmin pills can increase that risk up to three times compared to other oral contraceptives on the market. The Yasmin line of birth control pills includes Yaz, Beyaz and Ocella.

Bayer is also facing lawsuits over another of the company’s IUD devices called Mirena. The plaintiffs claim the company overstated the benefits of the devices in its advertising, while trying to conceal some potentially dangerous side effects.

Those side effects include the device’s tendency to embed itself in the uterine wall and move from its implantation site, causing organ perforation or scarring.

The Reuters report says Skyla, which is aimed at younger women who have not had children, will launch in the United States in February.

Patients should consult their doctors before making any changes in their medication. A consultation with a Mirena lawyer is also important if there are significant injuries from Mirena.

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