25 July 2018

Bayer Discontinues Sales of Essure Implants in the US

fda essure

Bayer permanent contraceptive Essure has been linked to repeated safety restrictions and thousands of injury reports. On July 20, the manufacturer announced it would discontinue sales in the US after Dec. 31, 2018. The US is the only market in the world where Essure is still available for sale or distribution. Bayer maintains that the permanent birth control is as safe as ever, but that weak sales were the reason for ceasing sales in US markets.

Bayer Under Pressure Over Essure

The device manufacturer has long been championing Essure as the only non-surgical sterilization method available for women. However, the increasing number of complaints worldwide over serious side effects caused demand to decline until Essure sales were pulled in the UK, South Africa, South America, Europe and Canada. Adverse events reports citing women suffering from bleeding, pain, allergic reactions and tissue damage caused by the device compelled the FDA to put a number of restrictions on Bayer’s Essure implant.

By May, the FDA began requiring physicians to have women sign off on a patient checklist of potentials risks before receiving the controversial birth implant. There have already been over 16,000 women in the US who’ve filed lawsuits against Bayer over the severe side effects associated with Essure. Some of these women are thrilled to hear that Bayer finally decided to pull the high-risk medical device from US markets.

The Controversial Essure Implant

Many of these women have been enduring pain and bleeding for years since having the Essure device implanted. The widespread suffering inspired many women to join the growing grassroots movements opposing Bayer and focused on holding the manufacturer accountable for exposing consumers to the dangerous Essure implant. When it first received FDA approval for the implant in 2002, Bayer promoted Essure as an easy, quick permanent solution for women faced with unplanned pregnancies.

The Essure device is comprised of two thin metal coils wrapped in synthetic fibers that are inserted into the fallopian tubes where they spur scar-tissue growth and block sperm from being able to fertilize women’s eggs. In 2016, the FDA ordered Bayer to conduct a study involving 2,000 patients and added the agency’s most serious warning to the device after an increasing number of adverse events reports started coming in from women suffering serious side effects.

FDA Providing Oversight to Protect Essure Patients

On the same day that Bayer announced it would pull Essure from the US by 2019, FDA Commissioner Gottlieb issued a statement saying that the company will still be obligated to meet its enrollment numbers in the postmarket analysis for the following the three years. The study is designed to follow these patients in an attempt to better understand Essure’s safety profile and potential complications in a real-world setting.

Over 750,000 women around the world have already received the Essure implant. Demand had been declining recent years, but sales dropped by around 70 percent after the FDA started requiring the new boxed warning label on Bayer’s controversial implant. Even with the Essure being removed from US markets, the FDA will continue monitoring the adverse events reported by injured patients. Gottlieb also said that women who’ve been successful with using Essure could continue to do so.

Health Risks Associated with the Essure Device

In addition, Gottlieb said that women who believe they’re suffering issues related to Essure should make an appointment to meet with a physician as soon as possible. The original label used on Essure warned consumers about potential allergic reactions related to the nickel used in the coil. The new labels require Bayer to detail the potential reactions, including developing itching, swelling, rash, and hives.

However, there are several other side effects patients attribute to this device, including headaches, hair loss, weight gain and mood disorders. These side effects are listed on the updated FDA label on Essure, along with a qualifier that its unknown whether these are directly related to Essure or some other causes. Informational materials provided to physicians and patients now say the implant is designed to be permanent and that removing it may require a complicated surgery, like a hysterectomy.

Avoiding Bayer’s Essure Mistakes in the Future

Gottlieb also noted that removing the Essure implant poses its own risks. One industry experts describe Essure as one of the medical devices approved by the FDA without having any clear evidence of safety or effectiveness. So when tens of thousands of women began reporting severe complications from the implant, there was no long-term, unbiased research available that could be used to corroborate or refute the adverse event reports.

If patients had listened to more during the clinical phase of testing, more research could have been conducted to determine just how safe or effective the device actually was. Some physicians are disappointed to hear about Bayer pulling Essure from US markets, as many of their patients were left satisfied. Still, even the physicians acknowledge Bayer’s need to improve their research and product development methods for future products.

Generally speaking, most physicians agree permanent birth control without surgery that is both safe and effective is a great option for patients to have access to. According to a company spokeswoman, Bayer has no plans to redesign the controversial birth control implant.

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