Pharmaceutical

Safety concerns surround Essure permanent birth control

Essure Safety concerns surround Essure permanent birth control“I think if you were to tell men you (were putting) a metal coil in their vas deferens … men probably wouldn’t do it. Like, ‘Are you kidding me? You’re going to put a piece of metal in my testicle?’ But with women, it’s just kind of OK,” Dr. Shawn Tassone told the Dallas Observer, referring to the Essure permanent birth control method, which has come under fire in recent months for side effects that were seemingly brushed aside for years. “We do kind of treat women’s health a little bit on the sly here in the United States,” he added.

Tassone said he and his colleagues were more than willing to implant women with the Essure device when it hit the market in 2002. Essure seemed like the ideal permanent contraceptive – it was the only non-surgical option on the market, offering more convenience and less recovery than surgical tubal ligation.

Essure consists of a nickel alloy coil that is inserted into each of the fallopian tubes. The body builds a natural scar tissue barrier around the coil, preventing pregnancy by preventing the sperm from reaching the egg. More than 750,000 Essure devices were implanted in women through the years.

But when women began to complain to their doctors with a litany of side effects including migraines, allergic reactions, infections, and severe pain, their concerns that the symptoms were caused by the implants were dismissed.

It took a few fed-up women and the social media site Facebook to bring the issue to light. Finally, women who claimed to have been injured by Essure had a forum to voice their concerns. Other issues came to light, including the device migrating and perforating the fallopian tubes or the uterine wall, or embedding into other organs. Many women required hysterectomies or surgical removal to find relief from symptoms.

Tassone is proud to say he was the first in Dallas to successfully remove Essure. He says he realizes now that the device has caused many women to needlessly suffer and he questions just how well Essure was vetted before it was approved for marketing in the U.S. He also asked why the manufacturer wouldn’t at least provide some guidance regarding safe removal of the implant.

He is not the only one who has questions for Bayer Healthcare, maker of Essure. The Facebook group Essure Problems has grown to more than 20,000 members with nearly as many posted complaints – enough to garner the attention of the Food and Drug Administration. The agency is currently reviewing adverse event reports with the device and should have its recommendations by early 2016.

Source: Dallas Observer