Different women advocates are demanding from US Food and Drug Administration to pull out Bayer's Essure, a permanent contraceptive device due to its other unknown possible harm to its users.
According to reuters.com, FDA had been contemplating whether to pull out Essure devices after reports of women complained that they experienced "life- altering" side effects such as chronic pain, bleeding, and autoimmune disorders like lupus and psoriasis.
Essure gained popularity when it was first cleared by the FDA last 2002 and used as non- surgical alternative to tubal ligation. Essure device is inserted through the vagina up to the fallopian tubes and it is made of two little nickel- titanium coils.
A Facebook group called "Essure Problems" is also made to give way for women experiencing problems with Essure to voice out their concerns. More than 5,000 women user if Essure have reported complains due to the usage of the product.
Mark Bell, a metals engineering consultant, said that the product is not safe to use after examining several Essure devices removed from the patients. He believes that there are latent "manufacturing processing problems" with the said device.
According to dailymai.co.uk, some of its users have complained that Essure's coils have been displaced from their fallopian tube to their pelvic cavity causing pelvic pain while others experience "debilitating fatigue" and symptoms showing that their body is reacting defensively against the device.
FDA had asked Essure's panel members, who are discussing the issue, that it should be finalized whether Essure can be used by certain group of women only or it can be used by all. Some of the panelists suspect that the nickel plays a big part in the negative side effects of the device.
Marsha Wills-Karp, chair of the department of environmental health sciences at Johns Hopkins University said that "It would be worth collecting information about nickel sensitivity to see if it is connected with some of the symptoms."
