Thousands of women in the United States are saying that the birth control implant called Essure has made them suffer from side effects like chronic pain, depression, fatigue, bleeding, allergic reactions, headaches and weight gain.
Following these complaints, the US Food and Drug Administration has decided to review the product. Medical experts representing the federal body will be taking a closer look at all the problems reported with Essure birth control implant.
This Monday, the FDA posted a 90-page long review of the birth control implant online. The agency has also organized a meeting this Thursday where medical experts will meet for reexamining the effectiveness and safety of the device.
Essure was launched onto the market 13 years back. However, the past couple of years have seen the FDA receiving a host of complaints from women using the device. Here, it must be mentioned that Essure is marketed as the country’s only nonsurgical permanent method of contraception.
Essure comes with a couple of small, metallic coils that need to be inserted into the user’s fallopian tubes. Upon insertion, these coils trigger the growth of the scar tissues, which perform the job of blocking sperm. Bayer has marketed the product as a nonsurgical alternative to different traditional surgical methods during which surgeons tie the fallopian tubes of women via the incision.
The warming label of Essure lists several risks and side effects, for instance, short-term bleeding and pain after the insertion.
Users are also warned that the birth control implant may slip out of its position and enter the user’s pelvis or lower abdomen, following which a surgery might be needed for removing the device. Also, some users may also experience allergic reactions like hives and itching when using Essure. This happens because the device is made using an alloy of nickel and aluminum.
However, since 2013, thousands of women have been attributing a range of other health issues to Essure; these are problems not listed on the product’s warning label. Some such issues reported are fatigue, depression, weight gain, and chronic pain. A large share of these complaints against the birth control implant has been shared via social networking sites. Facebook even has a page named Essure Problems that has more than 20,000 members.
The FDA will be asking its medical experts to analyze the seemingly conflicting info on the safety of the device. Studies carried out by the manufacturing company as well as other researchers are suggesting that long-term issues such as chronic pain are extremely rare with the Essure birth control implant. However, the FDA is looking to respond even to the patients’ concerns. At this moment, a large share of the patients wants the agency to recall Essure.