Manufacturer of Essure Permanent Birth Control Halts Sales; FDA Says Women Must Be Kept Informed About Serious Adverse Effects
In April 2018 the FDA issued an order restricting the sale and distribution of the Essure permanent birth control implant manufactured by pharmaceutical giant Bayer.
In a July 2018 statement, FDA commissioner Scott Gottlieb, M.D. assures that providing important safety information to women who have had an Essure permanent birth control implant “will continue to be a top priority” for the regulatory agency.
According to the July 2018 statement, “It was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness. The decision to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.”
Essure Manufacturer Should Be Held Accountable
“This is another case where medical device manufacturers must accept responsibility for harm resulting from the use of one of their products,” said Medical Malpractice Attorney and Registered Nurse Eileen Kroll of Cochran, Kroll & Associates.
In an article on July 20, 2018, the Washington Post explains: “The device, which was approved by the FDA in 2002, was initially hailed as a nonsurgical alternative to tubal ligation, commonly called having one’s “tubes tied.” It was developed by Conceptus Inc., a California medical products manufacturer that Bayer acquired in 2013.”
The FDA statement continues: “Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities. The device has been associated with serious risks including:
- persistent pain,
- perforation of the uterus and fallopian tubes,
- and migration of the coils into the pelvis or abdomen.”
“Although the FDA required the device to contain a serious warning label early on , and despite requiring Bayer to create a long checklist of potential problems for doctors to review with patients prior to implantation,” notes Attorney Eileen Kroll, “the watchdog agency found that it wasn’t enough.“
“Women were not being informed about potential risks,” Kroll stressed.
Bayer Pulling Essure Birth Control Implant From the U.S. Market as of December 31, 2018
Following the FDA’s restrictions, sales of the Essure device in the United States declined by approximately 70%. (The United States was the last remaining country where Essure was sold. According to the Washington Post article, Bayer had halted sales outside the U.S. in the fall of 2017.)
The FDA statement explains: “The company [Bayer] stated its decision to halt sales and distribution of the device was due to commercial reasons.”
“Regardless, the thousands of women who used the Essure permanent birth control device, and especially those who have been adversely affected, should be entitled to restitution,” said Attorney Eileen Kroll.
FDA Speaks Out On Essure Permanent Birth Control Potential Dangers
“This method of permanent birth control, where coils are inserted into the fallopian tubes creating a blockage that prevents the passage of an egg from the ovary, has been associated with numerous adverse events that were reported to the FDA including a significant collection of recent reports that have mentioned issues involving surgery to remove the device. We’re continuing our evaluation of these reports to better understand reasons for the device removal. The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.”
– FDA Statement, July 20, 2018
Eileen Kroll is a registered nurse and attorney and works on behalf of women suffering adverse effects of harmful medical devices. Kroll continues: “Suspected issues with the Essure Birth Control Implant arose as early as 2015 when the FDA began receiving patient complaints that included abdominal pain, abnormal uterine bleeding, and device migration. Concerns were escalated in early 2018 when the FDA saw a rise in reports of issues involving device removal.”
If you have an Essure implant, speak to your doctor about the risks
“Those who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take. Device removal has its own risks. Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them.”
– FDA Commissioner Scott Gottlieb, M.D., FDA Statement, July 20, 2018
Essure In The Media
A Netflix Original documentary released in early August 2018, called The Bleeding Edge, investigates how medical devices make it to the U.S. market, and exposes potential safety issues with the current process.
Patients with complications from the Essure implant are featured in the exposé.
Should You File an Essure Lawsuit?
According to the Washington Post article, “Bayer has been served with lawsuits representing more than 16,000 patients, the company said earlier this year.”
Women that have experienced complications from an Essure permanent birth control implant have a legal right to seek compensation for their injuries and suffering. It’s important to contact a medical malpractice attorney experienced in speaking up for women in cases against drug companies.
Eileen Kroll, Medical Malpractice Attorney and Registered Nurse of Cochran, Kroll & Associates can help determine if you have a case – at no cost to you. To schedule a free, no-obligation consultation, call 1-866-868-3779. Or for your convenience, submit our web form and Cochran, Kroll & Associates will contact you. Cochran, Kroll & Associates only earns our fee when we make a recovery on behalf of you or your family. If no recovery is made, you owe us nothing.
Learn more about how Cochran Kroll & Associates will work for you on Medical Malpractice and Product Liability Lawsuits.
“At this time, there are no class action lawsuits against Bayer for the Essure implant,” states Attorney Eileen Kroll. Each woman’s experience may be unique, but every woman deserves to have her case heard.”
Cochran Kroll offers a free case evaluation with no obligation.