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11/22/2024 04:48:42 am

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FDA to Hear Testimonies About Negative Side-Effects of Popular Permanent Birth Control Device

Bayer Pharmaceuticals

(Photo : Reuters/Fabrizio Bensch) Essure, a popular permanent pregnancy control implant, is under the scrutiny of the U.S. Federal Drug Administration (FDA) as several users have complained of negative side effects from using the device.

The Food and Drug Administration (FDA) is continuing its probe into a range of negative side effects reportedly caused by Essure, a permanent birth control implant approved since 2002. Several women are set to testify before the FDA's advisory committee on Thursday during a public hearing slated to address the mounting complaints and questions regarding the device's safety.

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The FDA has received over 5,000 complaints from users of Essure. A citizen petition, which claims that the clinical and approval process of the popular permanent birth control device were "replete with fraud," has also been filed by a Florida law firm. At least five cases have been filed regarding Essure side effects in the U.S. Court of Pennsylvania's Eastern District. Several women's health care advocates have called for authorities to pull the popular device from the shelves.

Essure, which was approved over 10 years ago, is a tiny coil which is implanted into the fallopian tubes. The coils are made of nickel alloy and a polyester-like fiber. It prevents pregnancy by triggering inflammation which causes scar tissues to form and block the tubes.

The FDA has reportedly received thousands of complaints about the device including cases of allergic reactions to the nickel alloy coil as well as coils migrating and perforating the fallopian tubes. Patients have also reported several symptoms including bleeding, headaches, chronic pelvic pain, painful periods and unwanted pregnancies.

Several patients have died as a result of trying to surgically remove the device. Four patients reportedly died during hysterectomies to fix the coils, which has migrated to other organs. Sometimes the coil reportedly broke apart. One patient committed suicide as a result of Essure complications.

Although several women claim that their medical records from the clinical trials were altered, the FDA said Thursday that its investigation into Essure has not revealed any intentional alteration of medical records.

Bayer HealthCare Pharmaceuticals, the company which bought Essure for $1.1 billion in 2013 from Conceptus Inc., said the safety of its patients was top priority. Officials at Bayer expressed their confidence in the Essure and its abilities. They also dismissed the allegations of altered medical records.

"We sympathize greatly with any woman who has experienced problems with Essure," Bayer's officials revealed.

Dr. Edio Zampaglione, Bayer's vice president for United States medical affairs and women's affairs said "It seems like the proper clinical practice procedures were followed."

"If a mistake was identified, it was crossed out, initiated and dated....there was full transparency," he said.

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