FDA threatens Bayer with penalties over contraceptive device

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As of recent, the FDA has become aware that women were not adequately informed of Essure's risks before receiving implantation of the device, despite past significant efforts to educate patients and doctors about the risk associated.

There will be new labeling for the device, which is now legally required, that restricts the sale and distribution of Essure to health care providers and facilities that provide proper information to patients about its risks and benefits.

"Patients deserve the most accurate and comprehensive information to help them make their health-care decisions, and Bayer has educated and continues to educate health-care providers about the importance of appropriately counseling each patient on the benefits and risks of Essure", the company said in a statement.

The patient brochure, "Patient-Doctor Discussion Checklist-Acceptance of Risk and Informed Decision Acknowledgement", must be reviewed with the prospective patient to ensure the patient understands the information about Essure implantation. And the agency said it will take appropriate action against Bayer, including imposing criminal and civil penalties, if the company does not follow through. That is simply unacceptable.

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Essure, a flexible coil inserted through the vagina into the fallopian tubes that prompts obstructive tissue growth, is meant to be a minimally invasive option for permanent sterilization. "Every single woman receiving this device should fully understand the associated risks".

Essure, approved by USA regulators in 2002, is a non-surgical and non-hormonal permanent birth control device.

Essure is the only permanently implanted birth control device on the market that does not require surgery. Over three months, scar tissue builds up around the coils, eventually creating a barrier that stops sperm from reaching the eggs. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions.

Bayer emphasized that the risk-benefit profile of Essure had not changed and that communicating risks with patients was in keeping with its values as the device's manufacturer. Some women have reported headaches, fatigue, weight changes, hair loss, and mood changes (such as depression). Two years ago, Essure got the FDA's strongest warning label.

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In the 16 years since approval, the FDA said it has received more than 26,000 reports of adverse events - nearly 12,000 last year alone - including miscarriages, fetal deaths, and other problems. Bayer announced in September that it would stop selling Essure outside the USA, but said it was for commercial, rather than safety, reasons.

"We really weren't expecting the FDA to do anything that actually benefited women, so this was a huge move for the commissioner to make", Firmalino said.

In February, the FDA and Bayer cited a new study that showed Essure is generally safe.

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