Bayer Pulls Essure Birth Control Product from Market

Bayer Essure

Withdrawal of Product Precedes Critical Documentary

Citing poor sales, as well as “inaccurate and misleading publicity” regarding its non-surgical permanent birth control device marketed under the name Essure, Bayer has announced that it will stop selling the product at the end of the year. The decision comes on the heels of an order from the U.S. Food and Drug Administration (FDA), issued in April, which significantly restricted sales of the device. The announcement also anticipates The Bleeding Edge, a documentary from Netflix that chronicles the side effects that have been reported by users of the Essure product.

At Bailey & Galyen, we have extensive experience protecting the rights of individuals who have suffered injury because of the poor design, manufacture or malfunction of a medical device. To schedule a free initial consultation to discuss a potential claim for damages caused by the Essure device, contact our office online or call us at 844-402-2992.

The Essure device, the only non-surgical contraception device currently on the market, involved the insertion of a metal coil into each fallopian tube, causing scar tissue to develop. The scar tissue creates a blockage, which is intended to prevent conception. The product was developed by Conceptus Inc. and received FDA approval in late 2002. While a 2009 review of the device found that it appeared to be effective, critics have alleged that the study was based on short-term studies only. Over the last five years, increasing controversy has centered on the device, with thousands of users claiming serious side effects, and many undergoing surgical extraction.

As of July 2018, more than 16,000 lawsuits have been filed, alleging a wide range of health problems, including fallopian tube perforation, serious pain and bleeding (some requiring hysterectomies) and even some deaths. While the company originally reported a failure rate of less than 1 percent, there have been hundreds of claims of unintended pregnancies in the past couple years. The device has also been linked to:

  • Nausea and vomiting
  • Allergic reactions
  • Rashes
  • Autoimmune disease-like symptoms
  • Back and joint pain
  • Numbness and tingling in extremities
  • Anxiety and depression, including thoughts of suicide
  • Weight gain
  • Hair loss

An FDA news release issued April 9, 2018, referenced the reports of pain and perforation and also expressed concerns that the coils could migrate from the fallopian tube to the pelvis or abdomen. FDA Commissioner Scott Gottlieb, M.D., stated, “We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.” Gottlieb further stated:

  • We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. 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.

The April order mandated that Bayer take additional steps to “provide reasonable assurance of the device’s safety and effectiveness.”

In all public statements surrounding the withdrawal decision, Bayer has insisted that liability issues and potential health risks tied to the product have not been a factor. A spokesperson said the “voluntary discontinuation” was “not indicative of safety issues,” and Bayer emphasized that it “stands behind the product’s safety.” However, the FDA says that, as of early 2018, more than 26,000 complaints have been logged with the agency related to the product, and that Bayer had another 11,000 complaints that it received directly.

Contact the Experienced Criminal Defense Attorneys at Bailey & Galyen

At the law office of Bailey & Galyen, we provide a free initial consultation to anyone with a potential Essure-based injury claim. To set up an appointment with an experienced Texas personal injury attorney, contact us by e-mail or call our offices at one of the convenient locations listed below. We will take your call 24 hours a day, seven days a week.

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Texas Jury Orders Johnson & Johnson to Pay More than $1 Billion

Pinnacle Hip Implants Found to Be Defective

On December 1, 2016, a federal jury in Dallas returned a verdict against pharmaceutical giant Johnson & Johnson and its subsidiary, DePuy Orthopaedics, holding that the company’s Pinnacle hip implant was negligently designed, that the company knew of risks associated with the product, and that the company failed to adequately warn consumers of those risks. The jury awarded six plaintiffs damages in excess of $1 billion—$32 million in compensatory damages and $1 billion in punitive damages. Johnson & Johnson had rejected a $1.8 million dollar settlement offer before trial.

The plaintiffs, who are California residents, say they suffered serious injury after receiving the DePuy product, including bone erosion and tissue death. They allege that Johnson & Johnson and DePuy falsely advertised that the Pinnacle hip implant, with its metal-on-metal design, was more durable and had a greater life than competing products that use plastic or ceramic parts.

Though plaintiff’s attorneys laud the verdict as a “loud and clear” message that Johnson & Johnson needs to address the legal issues related to the Pinnacle implant, most legal experts don’t see any movement any time soon. Attorneys for both companies say they will appeal the verdict and will ask the appeals court to suspend any further trials related to the hip implant.

The company faces more than 8,000 lawsuits tied to the device, all of which have been consolidated in the federal court in Texas. Last week’s verdict was the third “test case” regarding liability for the Pinnacle device. Johnson & Johnson was found not liable in the first case, but were hit with a $500 million jury award in the second trial. That verdict was subsequently reduced to $151 million, based on Texas law.

Contact Us
At the law office of Bailey & Galyen, we provide a free initial consultation to every Family Law client. To set up an appointment with an experienced Texas personal injury attorney, contact us by e-mail or call our offices at one of the convenient locations listed below. We will take your call 24 hours a day, seven days a week.

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DID YOU SUFFER ADVERSE SIDE EFFECTS AFTER RECEIVING THE NON-SURGICAL PERMANENT BIRTH CONTROL DEVICE ESSURE®?

The FDA has received thousands of complaints from women who suffered serious complications after receiving the non-surgical permanent birth control device Essure®, manufactured by Bayer. Some claim that Bayer knew about the adverse side effects, but concealed them from the public.

essure

The nationwide trial lawyers at Bailey & Galyen are currently investigating Essure® injury claims. If you or a loved one was injured, we invite you to contact us to discuss your potential financial recovery.

SIDE EFFECTS

Reported side effects range in severity from bloating to miscarriage.

  • Bloating
  • Excessive Bleeding
  • Rashes
  • Chronic Pain
  • Sharp Pelvic Pain
  • Miscarriage
  • Ectopic Pregnancy

Some women have had to undergo hysterectomy and hospitalization due to damage caused by the Essure® device.

ADVERSE EVENTS ASSOCIATED WITH THE ESSURE® DEVICE

Some doctors have reported various adverse events associated with the Essure® device, including:

  • Coils breaking off the device
  • Coils migrating from the fallopian tube
  • Coils puncturing the fallopian tube

Many women who experienced these adverse events after receiving the Essure® device are still living with pain, even after receiving a hysterectomy or other medical treatment.

Contact us today to assess your potential financial recovery!