The Food and Drug Administration (FDA) is planning to reinvestigate the safety of using Essure, the only available non-surgically implanted birth control device, due to the growing number of complaints associated with its use.
Previously approved by the FDA in 2002, a committee was formed to reevaluate the risks over benefits of Essure use when over 5,000 negative reports of persistent pelvic pain and swelling, dizziness, weight gain and fatigue were received. Symptoms that are not mentioned are possible side effects when using the device. The number of women affected grew to the point that it now has a dedicated Facebook page, Essure Problems, which has already more than 20,000 members.
"I didn't have these problems before," said Kim Hughes, 38, who reportedly experienced constant pelvic pain, irregular menstrual cycles and abdominal swelling after using Essure. "It completely changed my life."
Bayer Healthcare Pharmaceuticals, Essure's manufacturer, defends that their device is still safe to use and that, despite the relentless social media campaign against it, the adverse reactions on Essure affected only a small percentage of users.
"Clearly, the data for Essure shows the benefits outweigh the risks," said Edio Zampaglione, Bayer's Vice President of Medical Affairs for Women's Health. "There's nothing [we've seen] with the product itself that says we've got a defective product...that needs to be taken off the market."
Among healthcare practitioners and experts, the issue is still up for debate. There are a number of doctors who support continued Essure use and agree that the benefits presented by the birth control method outweigh the potential of side effects.
"I've probably done well over 1,000 patients by now," said Peter Rothschild, a gynecologist from Virginia. "I don't doubt that there are individuals out there who have [experienced adverse reactions]. But in my own practice, in my own personal experience, I have just not had patients with serious problems."
OB/GYN Mitchell Creinin also believed the same until more and more patients came back reporting problems. He became less convinced of the device's effectiveness when available clinical data reviews showed that Essure was not nearly as effective in birth control as previously believed.
Creinin said that he still believes that Essure is a suitable birth control device in some cases but that Bayer should be more honest regarding Essure's effectiveness and expected side effects of use.
"I think the way the company provides information to [doctors] and patients is not the entire story," he said. "The company's goal is to sell its product."
Essure is made of two small coils of nickel-titanium alloy, which are inserted into each fallopian tube. Over time, irritation, caused by the coils, causes tissue formation that blocks female egg cell fertilization, thus, prevents pregnancy. The device is said to have a success rate of 99 percent.
According to Bayer, more than 750,000 women have availed of Essure globally, with majority of the users coming from the U.S. Advertised expected side effects of use include short-term bleeding and pain-after-insertion as well as possible allergic reactions to nickel-titanium alloy like rashes and itching.
Photo: Sebastian Rittau | Flickr
