The FDA Takes Credit For Stopping Essure Sales
Essures sales fell by 70% prompting the halt of sales after the FDA took its final action to date to warn consumers
Wednesday, October 10, 2018 - Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA) recently released a warning statement regarding the dangers of the Essure birth control device that is worthy of repeating. The statement pertains to the FDA's "patient safety action" undertaken in April 2018. On that date, the FDA issued an order that restricted the sale of Essure to patients that signed a written statement attesting that they were aware of Essure's severe side effects. Dr. Gottlieb appears to credit the agency for Bayer's decision to voluntarily pull Essure from the market effective 12/31/18. "The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use," Gotlieb said. Bayer has complained that adverse publicity generated by the FDA questionnaire, Facebook groups, and the Netflix documentary entitled, "The Bleeding Edge" was "false and misleading" and caused demand for the device to plummet. Essure is being pulled from the market due to economic consideration according to a Bayer spokesperson. Doctors continue to swear that Essure is safe and effective and vow to continue to sell and use the device. Dr. Gotlieb warns Bayer must continue to meet its post-market responsibilities to complete the FDA's Essure adverse side effects questionnaire.
Dr. Gottlieb acknowledges in the abstract that the FDA has been made aware of the problems that women are experiencing with Essure. "Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities. The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen." Dr. Gottlieb's understanding of Essure's serious side effects falls short and fails to take into consideration the other side effects that have been reported en masse such as abnormal monthly bleeding, abnormal monthly cramping and bloating, allergic and autoimmune reactions such as full-body skin rashes, depression to the point of being bed-ridden, tooth and hair loss, headaches, lethargy, and so many more one might confuse the list with the symptoms of cancer chemotherapy.
Other steps Dr. Gottlieb credits to the FDA include conducting a thorough review of the FDA's MAUDE database regarding Essure problems and convening a panel discussion. The FDA has been criticized as having underreporting the number of Essure fetal deaths due to the inadequacy of its computer database query that limited their keyword search to the subject line only. The FDA ordered Bayer to conduct post-market Essure testing and to add a boxed warning to Essure, as well as the aforementioned patient/doctor checklist. "There has been an approximate 70 percent decline in sales of Essure in the U.S. since implementing these steps according to Gottlieb." These measures have been nearly as effective as a product recall. Efforts on behalf of the women members of the Facebook group Essure problems, consumer advocate Erin Brockovich, and US Congressman Fitzpatrick drew the commissioner's attention that more needed to be done to stop the sale of Essure. More needs to be done certainly, and for the 700,000 current Essure patients, a ticking time-bomb of Essure side effects may await them.
Source: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm614123.htm
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