FDA to Review Efficiency of Essure Contraceptive Implant

The Food and Administration (FDA) of the United States is set to review Essure (birth control implant device), following many complaints from women who have used the same. This implant promises to keep a female away from pregnancy for a long period, sometimes lifetime. It was given approval by the FDA in the 2002 year. This small metal spring is put in comfortably for the fallopian tubes. The obstruction created does not let mature eggs pass through for causing pregnancy. Unlike birth control pill, the product is an intra-uterine device, while the former can be taken orally.

Side Effect Stories about Bayer’s Birth Control Device:

The safety of this device has been questioned by users, as many did face disappointing side effects. The FDA cited that it will follow a meeting for reliability of Essure. In the recent years of the past, the Agency confronted patients and their advocates for understanding their experiences and problems with the contraceptive device. The efforts are being continued to understand user’s stories in a better way to address the root cause of the scenario. The manufacturer of Essure, Bayer did inform audiences that the side effects to this device are migration of the same, rash, or pelvic pain.

But women say that they have received negative fallouts other than mentioned possible side effects, which were not even closer to what birth control pill consequences were. A 37 year old female, Melanie Goshgarian told news that she bled heavy and felt metallic flavor in mouth when the device was implanted in her. Melanie recounts that her body felt different as it began to itch often, legs and arms constantly tinged, and she was facing a bout of confusion all the time.

The Role of FDA and Essure Manufacturer:

The FDA reported that it had received 20,000 complaints from users, who also spoke about their experiences on Twitter and Facebook. Their agency will adhere to certain limitations when the review of such stories will be done for Essure. In the last 2 years, there has been an increase in the rare of complaints and side effect events submitted by the people in relation to this contraceptive device. The Bayer officials were glad enough to propose their support and opportunity in discussing about their said product with the Food and Drug Administration.

The manufacturers of Essure noted that before launching the product in market, it was tested safely on 10,000 women, who did not report of any usual activities. But, Bayer is still supportive in prioritizing patients’ safety and has sympathized to the users who went through problems with their contraceptive device. They have affirmed about welcoming an open dialogue between them and the patients or those who have any queries for Essure.

Opinions of Experts:

Dr. Deborah Bartz, a gynecologist and obstetrician from Brigham and Women’s Hospital said that for many female, the Essure device is the most feasible and best alternative to permanent birth control. But, for some people, the use of such products may not be idea because of serious medical conditions, which could defy the possibility of surgery to fallopian tubes.

Dr. Karen Ashby (obstetrician and gynecologist) from at the University Hospitals Case Medical Center told the news that as Essure may be difficult to remove, women may be prone to itchy skin and long-period pain, while others could be allergic to metal, leading to complications.

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