The Essure® Lawsuit: Revoking Premarket Approval

** February 2016 FDA Update **

On February 29, 2016, the FDA announced that it will require Bayer to include a black box warning label for the Essure® device, the strongest cautionary packaging that the administration can recommend. The announcement comes after nearly three months of deliberation concerning women who have experienced varying degrees of complications after having the device implanted. In addition to the new packaging requirements, the FDA said that Bayer must design and conduct a post-market surveillance study to determine the safety of the device and compare the outcomes of Essure® patients to those that have undergone laparoscopic tubal ligation, specifically the rates of complications. The new draft guidance is also expected to include a "patient decision checklist" that healthcare practitioners can use to discuss the possible complications associated with the device. The FDA is also recommending that patients have a confirmation test three months after device implantation to ensure that it is in place and working properly.

The Essure® Device and Placement Procedure

Essure® consists of two small, flexible coils that are inserted through the vagina and cervix, and implanted in the fallopian tubes. The placement procedure can generally be accomplished in about ten minutes and does not require any incisions. The Essure® device contains polyethylene terephthalate fibers that will induce inflammation within the fallopian tubes. This is intended to encourage tissue growth around the device over the first three months to form a blockage in the fallopian tubes that creates a barrier to restrict sperm from reaching the woman’s eggs and prevent conception and pregnancy.

The Essure® lawsuit alleges that the original manufacturer concealed evidence of adverse risks from the FDA in order to receive this approval.

When the device has been in place for about three months, the patient will need to see a radiologist to have a hysterosalpingogram (HSG) performed. This procedure is an x-ray imaging study of the internal anatomy of the uterus and fallopian tubes using a contrast dye. This allows the doctor to confirm that the Essure® device is working properly and completely blocking the fallopian tubes.

The Essure® Lawsuit

The Essure® device received premarket approval in 2002, which essentially prevents anyone from filing a lawsuit against the manufacturer or marketer in the event of an injury. The Essure® lawsuit alleges that the original manufacturer, Conceptus Inc., concealed evidence of adverse risks from the FDA in order to receive this approval. Additionally, the lawsuit claims that the manufacturers and marketers of the device have since failed to properly warn both patients and physicians of the risks associated with Essure®. Conceptus Inc. is a subsidiary of Bayer AG, and the companies that have been named in the lawsuit include Bayer Corp., Bayer Healthcare, LLC, Bayer Essure, Inc., Bayer Healthcare Pharmaceuticals, Inc., and Bayer AG.

Premarket Approval and Preemption Laws

In order to obtain premarket approval, the medical device in question must be reviewed to evaluate its safety and effectiveness. Because of the inherent danger associated with these types of devices, premarket approval is the most stringent type of patent required by the FDA. Premarket approvals are only granted to products that have sufficient scientific evidence of their safety and effectiveness for their intended uses.

Devices that obtain premarket approval from the FDA are preempted by the Medical Device Amendments Act from litigation brought by patients who suffer complications. This makes bringing a case against the manufacturer and marketer of the Essure® device difficult, but legal experts say that this preemption is not absolute.

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The FDA has received numerous petitions from women who claim that the manufacturer committed fraud during the premarket approval process. If the FDA determines that Conceptus Inc. did in fact withhold data from the agency, Bayer would be forced to forfeit their protection under the preemption laws.

Essure® and Premarket Approval

Essure® was pushed through the FDA’s expedited approval program, which gives doctors and patients access to new drugs and devices that are in great need. The Essure® device was given this designation with the condition that the manufacturer follow their study participants for a minimum of four to five years after the procedure. This follow-up study was completed in 2007, but the data was not published and made public until 2015.

The published data brought to light some troubling findings from the study, including:

• Of the original 518 participants in the study, oly 366 were actually followed for the full five years
• Of the 366 women that were followed, 15 had hysterectomies after using the device
• 38 percent experienced unusually heavy periods
• Five percent suffered recurrent pelvic pain
• Four percent reported that they had experienced painful intercourse

Additionally, Bayer would not disclose how many women had undergone the Essure® implantation procedure, so it has been difficult to estimate the risk-to-benefit ratio.

Many women who were participants in the study have stated that the manufacturer’s researchers concealed reports of patients suffering extreme pain after implantation. Multiple patients have come forward alleging that their answers to researchers’ questions were altered in order to gain approval for the device.

Common Side Effects from Essure® Implantation

There are several short-term side effects that patients may experience following their implantation procedure with the Essure® device, including:

• Mild to moderate pain
• Pelvic or back discomfort
• Vaginal bleeding
• Cramping

In addition to these short-term risks, the FDA has received over 5,000 medical device reports related to Essure®. Most commonly, these reports are of patients experiencing pain, menstrual irregularities, headaches, fatigue, and weight fluctuations.

Complications Leading to the Essure® Lawsuit

Many women have experienced serious and harmful complications following their Essure® implantation procedure, similar to those experienced by Mirena® patients. This has led them to file claims against the manufacturer, including,

• Unintended pregnancy
• Ectopic pregnancy
• Fracture of the Essure® device
• Migration of the Essure® device
• Perforation of uterus or fallopian tubes
• Complications from nickel allergy
• Complications requiring hysterectomy

Device migration is the most common cause of the other complications. Similar to the IVC filter lawsuit, when the device becomes dislodged it can damage blood vessels and organs throughout the body.

Women who experienced complications that required a hysterectomy were then put at risk for further complications associated with this procedure. Patients frequently need to have additional surgeries after undergoing a hysterectomy, and a lawsuit against the responsible parties may be the only way for these women to recover their financial damages.

The E-Free Act seeks to revoke the premarket approval status of the Essure® device.

Many women did not experience complications until after they had returned for their three-month follow-up appointment and imaging study. This eliminates the possibility that the device was placed incorrectly and restricts the cause of the complications to faulty design. Many of the complaints that have been filed allege that the manufacturer and marketer of the device knew about the increased risk of these complications and purposefully concealed them in order to obtain approval by the FDA.

The E-Free Act

Congressman Mike Fitzpatrick of Pennsylvania has introduced the E-Free Act to the House of Representatives. This bill seeks to revoke the premarket approval status of the Essure® device, removing the legal obstacles that patients have faced when filing claims against Bayer.

Journal and News Articles Concerning Essure® 

• In an article in the journal Radiologia that was published in May 2015, researchers found that the most common complications with the Essure® device are migration, perforation, and failure to completely block the fallopian tubes. The article also discusses the importance of the radiologist’s role in identifying any complications when viewing an imaging study during a follow-up appointment.
• A November 24, 2015 article in U.S News and World Report, states that the FDA has set a February 2016 target date to take action on the Essure® device. The FDA is currently “working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps.” In September 2015, the FDA convened a public meeting where a panel decided that more information is needed concerning the device, and that the warnings about Essure® may need to be updated.

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If you have experienced complications after having an Essure® device implanted, please contact our experienced defective products attorneys immediately. We are expecting a decision regarding the premarket approval status and preemption laws concerning Essure® in the near future.