Restricting the sale of the Essure birth control device. As announced in an April 9, 2018 Release, the U.S. Food and Drug Administration (FDA), has issued an order restricting the sale of the Essure birth control device and requiring additional risk information to be shared with patients. The Essure device, manufactured by Bayer, has been the subject of increasing scrutiny regarding its safety. This step by the FDA is the latest in a series designed to make warning information about Essure more accessible to women.
Essure is the Only Non-Surgical Permanent Birth Control Device
Essure is the only medical device on the market that allows for permanent, non-surgical sterilization in women. Prior to 2002, women desiring permanent pregnancy prevention had the option of undergoing surgery in the form of tubal ligation or potentially hysterectomy with bilateral salpingo-oophorectomy. In 2002, the FDA approved Essure as a supposed non-invasive method of permanent birth control and alternative to surgical sterilization.
The Essure system consists of two tiny flexible metal coils that are made of stainless steel, nickel titanium-alloy, and synthetic fibers. The coils are implanted through a woman’s vagina and cervix and into the fallopian tubes. This process is carried out without the use of any surgical incisions.
Following implantation, an inflammatory response takes place around the coils, which results in scar tissue forming entirely around each coil. The scar tissue then blocks each fallopian tube, having a similar effect to a surgical tubal ligation. When the fallopian tubes are blocked, egg and sperm cannot meet, and a woman will not become pregnant.
Adverse Event Reports, FDA Oversight Mount
Bayer estimates that approximately 750,000 women worldwide have received the Essure implant since 2002. Between the time of the FDA’s approval of Essure, on November 4, 2002, and December 31, 2017, the FDA has received 26,773 medical device reports related to Essure implants in women in the United States. The FDA stated that most of these reports were related to:
- Pain/abdominal pain (21,215 reports)
- Heavy periods or irregular menstruation (9,846)
- Headaches (7,231)
- Fatigue (5,842)
- Weight fluctuations (4,970)
- Possible nickel allergy (4,481)
- Migration of the device or device component (2,936)
- Dislodgement or dislocation of the device (1,356)
- Breakage of the device (1,044)
- Device operating differently from expectation (947)
- Device difficult to remove (331)
- Device difficult to insert (317)
- Device in incorrect location (279)
The FDA also received 34 adverse event reports of deaths attributed to complications arising out of use of the Essure device: 10 reports of adult deaths, 20 reports of fetal deaths, and four reports of infant deaths. In addition to these reports, between 2002 and 2017, the FDA also received reports of pregnancy in women in whom the Essure device had been implanted. The FDA counted a total of 1,826 reports of pregnancy following implantation of Essure, resulting in 365 live births and 875 pregnancy losses.
In February 2016, in the face of ever-mounting reports of adverse events, the FDA ordered Bayer to conduct post-market surveillance of Essure to determine the safety and efficacy of the device in real-world practice. The FDA also indicated it was considering at the time adding a “black box” warning to the Essure device package label. A black box warning is the most serious warning available for medical devices. When the FDA requires this type of warning, severe risk information must be displayed prominently at the top of the label for the device in a bold black box.
Approximately eight months later, in October 2016, the FDA did order a change to Essure’s package labeling that included the anticipated black box warning, as well as requiring Bayer to add a new patient brochure containing information about Essure. The brochure, called a Patient Information Booklet, provides detailed risk information about Essure, information about alternatives to Essure (including oral contraceptives and condoms), and a Patient-Doctor Discussion Checklist and Acknowledgment to be reviewed between the patient and her physician.
The Essure device label and the Patient Information Booklet both contain the black box warning, which reads:
“WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during the discussion of the benefits and risks of the device.”
Following these actions by the FDA in 2016, Bayer saw a 70 percent decline in the sale of the Essure system in the United States. However, the FDA and many patients and physicians continued to be concerned about awareness of the risks associated with Essure. Members of the public and affected women continued pushing for the device to be pulled from the market.
In February 2018, FDA Commissioner Scott Gottlieb, M.D., met with a group of women who had suffered complications from Essure and listened to their reports of complications and concerns about the continued use of the device. Many of these women again urged the FDA to issue an Essure device recall. In a Release about this meeting, Commissioner Gottlieb said the FDA “continue[d] to believe that Essure may be appropriate for some women” but added that the Administration also recognized that “serious problems have been associated with its use.”
FDA Restricts Sales, Requires Additional Step in Essure Informed Consent
In the months that followed Commissioner Gottlieb’s meeting with consumers, the FDA continued to monitor reported safety issues concerning Essure. On April 9, 2018, the Administration announced it was ordering Bayer to restrict sales and distribution of Essure to “only health care providers and facilities that provide information to patients about the risks and benefits of this device.”
In its Release regarding the new order, the FDA included quotes from Commissioner Gottlieb in which he said: “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
In its April 9 order, the FDA required Bayer to restrict sales to only physicians and facilities that review the Essure Patient-Doctor Discussion Checklist and Acknowledgement with women who are considering Essure, and that give these women the opportunity to sign the Acknowledgement before undergoing implantation of the device.
In addition, the FDA ordered more changes to the Essure package labeling. The Essure label must now also include the statement: “The sale and distribution of this device are restricted to users and/or facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”
The FDA said it intended to review and monitor Bayer’s plans for complying with its new order and would take necessary action if Bayer failed to comply, which could include “applicable criminal and civil penalties.”
Parker Waichman LLP Reviewing Essure Cases
Free Case Consultations Provided
Parker Waichman LLP, a nationally recognized product liability firm, is actively litigating cases against Bayer involving Essure injuries. We are reviewing new cases and offer free, confidential case consultations with our experienced lawyers. You can reach our firm to schedule a free consultation regarding your own case by calling 1-800-YOURLAWYER (1-800-968-7529) or by filling out the contact form on our website.
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation