Which Birth Control Implant Has Just Received the Most Severe FDA Warning?

Which Birth Control Implant Has Just Received the Most Severe FDA Warning?

Essure, a controversial birth control device that’s been on the market for more than a decade, has recently been reevaluated by the Food and Drug Administration and labeled with a more severe warning for doctor and patient consideration.

Essure is a permanent form of birth control designed for women interested in non-surgical sterilization. The implant is composed of two nickel-titanium coils that are inserted into the fallopian tubes. The coils creates scar tissue in the fallopian tubes, blocking sperm from fertilizing the eggs. Over 750,000 women have received the implant since its appearance on the market in 2002, however, despite it’s popularity, Essure has received a bad reputation for it’s dangerous side effects.

After using Essure, thousands of users reported an abundance of severe and long lasting side effects, including pain, bleeding, and perforation of the fallopian tubes by the coils. After these side effects became public knowledge, many users demanded that the device be recalled.

The FDA has called for public input and further inquiry about the risk of these side effects in comparison with other surgical sterilization methods, but for now, has not recalled the product. Instead, Essure will be given a box label, the most serious kind, to warn users about the possible side effects. Bayer, the company that manufactures Essure, released a statement on the controversy saying, “Essure is an important permanent birth control option with a positive benefit-risk profile.” Bayer has also committed to working with the FDA on this issue.


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