|Who the FDA is really protecting: FDA says more studies needed and orders strict warning on Bayer’s Essure device, yet leaves product on market|
|Written by Marcus Susen|
|Wednesday, 14 December 2016 00:00|
A black box warning will now accompany Bayer’s Essure permanent birth control device. The FDA recently ordered that such warning be placed on Bayer’s Essure device. Although a black box warning is the strictest and strongest warning that the FDA requires, the FDA did not stop there. They also recommended that the device include a patient-doctor checklist and ordered Bayer to conduct more studies. However, notwithstanding these actions, the FDA and Bayer chose to leave the product on the market.
These measures were taken after thousands of adverse events and medical device reports had been filed with the FDA which included reports of the inserts migrating out of the fallopian tubes, breaking, and perforating internal organs. Other reports note allergic reactions (teeth and hair falling out), ectopic pregnancies, still births, and even death.
Essure is a birth control device manufactured by Bayer Healthcare. The device was developed to prevent pregnancy through the insertion of micro-inserts into the fallopian tubes that then expand and anchor, causing tissue growth and, in turn, bilateral occlusion (blockage) of the fallopian tubes. It was intended to be a gentle, permanent, and non-surgical procedure.
However, the black box warning and patient-doctor checklist now warn of risks such as persistent pain and the need for surgical removal and advise patients of other symptoms being reported to the FDA, such as headaches, fatigue, weight changes, hair loss, and depression.
These actions taken by the FDA raise serious questions for patients and doctors alike, such as why is the product still on the market if more studies are needed? How can doctors inform their patients of the risks of allergic reactions to the metals (nickel, titanium, iron chromium, platinum and silver-tin) when Bayer and the FDA acknowledge that there is no reliable test to predict who may develop such reactions? How are physicians supposed to surgically remove the “permanent” device? It appears as though the FDA and Bayer’s actions leave women with more questions than answers.
During the FDA approval process for Essure back in 2002, where the safety and efficacy of Essure was analyzed by the FDA and the manufacturer, these exact concerns were raised, but ignored during a panel meeting of experts convened by the FDA. Something all doctors and patients should know of, not communicated in the black box warning and doctor-patient checklist, is the context of how this device was “conditionally approved” by the FDA.
According to the transcript of this panel meeting, when the issue of sensitivity to the metals in Essure was brought up, one expert responded: “I don’t know what happens to people with metal sensitivity when you implant metals in them.” Another expert joked that the only metal she was not sensitive to was “14k (laughter)” and “18k” gold. The joking did not stop there. In fact, the Chair of the meeting referred to the Essure patient population in Iowa as “those corn fed girls (laughter).” However, most concerning of all was a statement by a panel doctor who was concerned that, if the device was approved, someone would eventually “find each of us, bring us back here, and ask us why we approved this (laughter).”
Well, that time has come Doctor and no one is laughing.
Marcus Susen is a partner with the law firm of Koch Parafinczuk and Wolf based out of Ft. Lauderdale, FL. Mr. Susen was the author of the Citizens Petition/Trade Complaint which was filed with the FDA requesting that the Essure device include a black box warning and be taken off the market. He currently represents hundreds of women who have been injured by the Essure device in courts across the country.
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