Sunday, 21 July, 2019


FDA restricting sales of permanent birth control over risk concerns

FDA restricting sales of permanent birth control over risk concerns FDA restricting sales of permanent birth control over risk concerns
Patty Aguilar | 10 April, 2018, 22:24

The F.D.A. said on Monday that from November 4, 2002, when Essure was approved, through December of a year ago, the agency had received 26,773 reports of adverse events related to the device, although some might be duplicates.

The agency said it became aware that some women were not being fully informed of these risks tied to Essure, "despite previous significant efforts to educate patients and doctors about the risks associated with this device".

In February 2016, the FDA ordered Bayer to add a warning and patient decision checklist to the product's labeling.

Bayer is required to implement the FDA's restrictions immediately. The FDA says failure to comply will lead to applicable criminal and civil penalties. The updated patient brochure, which includes the new "Acceptance of Risk and Informed Decision Acknowledgement", must be reviewed with the patient to ensure that she understands the information regarding Essure.

The FDA on Monday announced strict new requirements on the controversial Essure sterilization device, which already comes with a "black box warning", the strongest warning label the agency can require.

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

On Monday, the FDA is taking action, saying it's simply unacceptable that women are not being told about all the risks.

Essure, approved by the FDA in 2002, is a permanently implanted contraceptive device for women that does not require a surgical incision. During a procedure that can be done in a doctor's office, the coils are implanted in the fallopian tubes to scar them shut, preventing pregnancy. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information. Adverse events such as 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 have been reported in some women after Essure implantation.

The new requirement comes nearly two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant.

The new checklist is now legally required when the product is offered to the patient and must be signed by the implanting physician.

Essure, approved by USA regulators in 2002, was given the strongest safety warning label on the device in early 2016 following thousands of complaints.

In a press statement, Bayer reiterated that the benefit/risk profile of Essure has not changed and remains positive. Although Bayer's post-market study now has demonstrated adequate progress, including tripling of the total number of enrolled patients over the past six months, the FDA plans to require Bayer to increase the number of participating study sites to account for the declining sales volume.

"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.

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