FDA is facing criticism from women who say that Bayer’s Essure birth control device caused serious injuries. The U.S. Food and Drug Administration (FDA) is facing criticism from women who say that Bayer’s Essure birth control device caused serious injuries. Following complaints of injuries related to the device and allegations of clinical trial fraud, the agency scheduled a panel meeting to take place in September. However, Fierce Medical Devices reports that advocates are riled up because the meeting date coincides with Pope Francis first-ever papal address to Congress.
There are over 9,000 members in the Facebook group “Essure Problems”, which is calling on the FDA to remove Essure from the market. Famed activist Erin Brockovich spearheaded the group, according to Fierce Medical Devices. Angela Desa-Lynch, an administrator for the group, told Catholic News Agency that the FDA knew the meeting would take place on the same day as the Pope’s visit, drawing media attention away from Essure. Essure Problems and other advocacy groups are planning to launch a hunger strike after the meeting takes place.
FDA spokeswoman Deborah Kotz told the CNA that the agency did not intentionally schedule the meeting to coincide with the papal visit. She stated that the pope’s U.S. visit itinerary was released on June 30, 6 days after the FDA announced the Essure panel meeting. According to CNA, however, the Pope’s visit date was released as early as February 5th.
When Bayer acquired Conceptus, it picked up Essure with it
When Bayer acquired Conceptus in 2013, it picked up Essure with it. The FDA approved the device in 2002, and has received over 5,000 complaints since then. Most of the complaints are from after Bayer’s acquisition of Conceptus. In April, the FDA said it would investigate complaints over Essure. The device is comprised of two flexible metal springs placed in the fallopian tubes. Pregnancy is prevented as scar tissue grows around the springs.
In citing a 5-year study, Bayer has insisted that only 7 percent of participants suffered from pelvic pain. However, these claims have come under scrutiny. The New York Times cited data from a long-term trial published in the Journal of Minimally Invasive Gynecology and pointed out that only 366 out of 518 participants were followed for the full 5 years. Additionally, NYT reported that many women who were followed still reported problems related to Essure, such as abnormally heavy periods and recurrent pelvic pain.
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