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.

IMPORTANT INFORMATION ABOUT DANGEROUS MEDICAL DEVICES AND DRUGS

You are receiving this letter because Bailey & Galyen had or has an attorney client relationship with you or a family member. As such, we want you to know about these dangerous medical devices and drugs that have caused serious injuries and damages: Hernia Mesh Implants, Inferior Vena Cava (IVC) Filters and Xarelto.


hernia mesh implants

HERNIA MESH IMPLANTS

Hernias occur when a hole or weak spot occurs in the muscle or connective tissue that allows an organ, intestine or fatty tissue to come through the body cavity or abdominal wall. Two of the most common hernias occur in the inner groin (“inguinal”) and in the general abdominal or ventral wall (“ventral”). Hernias must be addressed, and ultimately corrected by surgery. The surgery can be laparoscopic where several small incisions that are made allow the surgeon to repair the hernia with surgical tools, or by open repair where an incision is made to perform the repair. Hernia mesh has been used frequently in the incisional repair procedure. While surgical mesh may decrease the high hernia recurrence rate, it has many serious complications. The FDA’s own analysis of hernia mesh medical device adverse event reports and of peer-reviewed, scientific literature found that the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration and mesh shrinkage (contraction).

There are two polypropylene mesh “sandwich” products, Ethicon’s Physiomesh and Atrium’s C-QUR. In 2006, Atrium began to market and sell its C-QUR product, and in 2010, Ethicon began to market and sell Physiomesh. The word “sandwich” is used here to describe the polypropylene component being laminated between two layers of poliglecaprone, a bioresorbable polymer used to form an anti-adhesion barrier between the polypropylene and the host tissue. This anti-adhesion barrier increases the risk that the graft will not incorporate into the abdominal wall, causing the graft to fold, buckle and migrate, posing a threat to adjacent organs. It is also known to incite an inflammatory response in the implant’s surrounding soft tissue. That inflammatory response can cause complications that include but are not limited to pain, graft rejection, graft migration, organ damage, adhesions, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis, and death.

On May 25, 2016, Ethicon sent a worldwide letter to doctors recalling their hernia repair product Physiomesh. On August 9, 2013, the FDA announced a class 2 recall of the C-QUR mesh.


Inferior Vena Cava (IVC) Filters

INFERIOR VENA CAVA (IVC) FILTERS

An IVC FILTER is a small medical device that is inserted into the inferior vena cava, a large blood vessel that brings blood from the lower half of the body into the heart. These filters are a temporary measure to catch blood clots and prevent them from traveling into the lungs.

In recent years, inferior vena cava (IVC) filters have been at the center of controversy and litigation. Reports of defective IVC filters, left in the body too long, have been associated with serious health consequences and even death.

Retrievable IVC filters are designed to remain in the body for a short period of time, and must be removed when the risk of PE diminishes. When not removed in a timely manner, these filters can cause serious health problems, including tilting or the filter moving out of position, migration or movement of the filter in the vena cava, perforation or piercing of the vena cava wall that the filter is attached to that can cause internal bleeding, and fracture or breaking of the legs of the filter allowing the legs to move through the body and affect vital organs and the spine.

These life-threatening complications are usually the result of a defective medical device. Though there are several manufacturers of IVC filters, there are two that have been the center of litigation: Cook Medical and C.R. Bard. Five filters, in particular, have been associated with an increased risk of injury:

  • Cook Celect
  • Cook Gunther Tulip
  • Bard G2 Express
  • Bard G2
  • Bard Recovery

Xarelto (Rivaroxaban)

XARELTO (RIVAROXABAN)

Xarelto is a newer anti-coagulating agent (blood thinner), preventing blood from clotting. Originally researched, developed, and clinically tested by Bayer AG in 2010. Through a joint-venture agreement, Janssen R&D, LLC acquired rights to co-develop Xarelto in the U.S. Janssen also filed and supported NDA process for FDA approval. Janssen holds U.S. marketing rights for Xarelto, and Bayer AG co-promotes Xarelto to US hospitals through its well-established sales force.

Xarelto received its first approval as a prophylaxis in preventing Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in patients undergoing hip or knee replacement surgeries on July 1, 2011. A short 4 months later, on November 2, 2011, Xarelto was approved for treatment of DVT and PE, and the reduction in risk for DVT and PE. This approval opened the door to Xarelto’s enormous financial potential for Janssen and Bayer. Since November 4, 2011, Xarelto has been approved for treatment to reduce the risk of stroke and systemic embolism in patients with non-valvular Atrial Fibrillation (or Afib).

Xarelto is prescribed to reduce the risk of stroke and blood clots in individuals with atrial fibrillation, to treat deep vein thrombosis and pulmonary embolisms, and to reduce the risk of blood clots forming in the lungs and legs of individuals following knee or hip replacement surgery. Its advantage over the class of anticoagulant drugs is that it does not require regular blood monitoring, no frequent dosage adjustments, and no known dietary restrictions. However, Xarelto can pose serious and life-threatening uncontrolled bleeding.

Xarelto has been linked to:

  • Gastrointestinal bleeding
  • Cerebral hemorrhage
  • Excessive menstrual bleeding
  • Excessive nose bleeds
  • Unexplained bruising
  • GI discomfort
  • Blood in stool and/or urine

Manufacturer Janssen failed to provide adequate warnings about the risks of taking Xarelto. It failed to advise the medical community and its patients that there is no antidote, meaning that once a bleed develops, doctors may have no way to stop the bleed.

If you, a friend or family member had one of these medical devices implanted in them or suffered a serious injury from the dangerous drug, Xarelto, call Bailey & Galyen at 281.549.9555 to discuss your potential product liability claim against the medical device and drug manufacturer. The doctor who implanted the medical device or prescribed the drug is rarely sued in these cases, as these are product defect cases against the manufacturer of the defective and dangerous products.

Sincerely,
Phillip Galyen

Principal Office Bedford, TX

Study Shows Increased Use of Prescription Drugs

PharmaceuticalAccording to a study published in the Journal of the American Medical Association (JAMA), the use of prescription pharmaceutical products has skyrocketed in the United States over the last 10 years. Researchers used information gathered as part of a National Health and Nutrition Examination Survey, looking at nearly 40,000 Americans over the age of 20. The study found that the use of prescription drugs went up approximately 60% from 1999 to 2012. The same time frame saw “poly-pharmacy” use—use of five or more prescription drugs at the same time—increase by nearly 15%.

Here are some of the other findings of the study:

  • The most commonly prescribed pharmaceutical products are those typically used to treat people who are overweight or obese, such as high blood pressure, heart disease, diabetes and high cholesterol.
  • The use of prescription anti-depressants doubled during the decade, from 7 to 13 percent, while the use of prescription blood pressure medications went up by a third. Those increases paled in comparison to the jump in anti-cholesterol medications, which quadrupled during the period of the study.
  • Some prescription drugs actually saw a decline—antibiotic use went down, with many in the profession speculating that users had built up a resistance and that the drugs were no longer effective.
  • The largest increase in prescription drug use was in the above-65 age group—an increase of almost 40%. Researchers concluded that the aging of the baby boomer generation has had a significant impact on the use of prescription drugs.

Contact Us

At the law office of Bailey & Galyen, we provide a free initial consultation to every client. To set up an appointment with an experienced Texas pharmaceutical products 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.

Adverse Side Effects from Mesh Implants

Experienced Medical Product Liability Attorneys—Hernia Mesh

Divorce

If you’ve had surgery to repair a hernia in the past few years, or even as long ago as the late 1980s, there’s a chance that a surgical mesh was implanted as part of the process. The mesh is a loosely woven sheet that may be made from organic or inorganic materials, and that may dissolve over a period of time or may be permanent. You may have had mesh implanted in a laparoscopic procedure or in what is known as “open repair.” The mesh is designed to reinforce weakened or damaged tissue, and to minimize the risk of a recurrence of the hernia.

The implantation of hernia mesh has been linked to a number of adverse health complications, including infection, bowel obstruction, severe pain, perforation of internal organs, adhesion and mesh failure (leading to recurring hernias). The FDA has received reports of injuries caused by mesh shrinkage, as well as movement or migration of mesh after surgery. As a consequence, a number of surgical mesh products have been subject to recall.

Do You Have a Claim?

Our experienced lawyers will carefully review your case, looking at medical records and gathering evidence to support a claim for damages. To qualify for a consultation with our experienced team, you must show the following:

  • You’ve had at least two or more hernia repair surgeries using surgical mesh (either implant or explant)
  • At least one of the surgeries was done after January 1, 2010

We will make exceptions to the following conditions if:

  • You have a second hernia mesh surgery scheduled, with a specific date and location
  • You have medical records that document that the mesh implanted was either Physiomesh or C-QUR mesh
  • Your doctor will testify that he/she believes that a hernia mesh implantation has caused you injury, but also believes that the mesh cannot be removed without the potential for serious injury

Contact Our Office for a Free Initial Consultation

You may have concerns about the potential cost of pursuing recovery for a hernia mesh injury. Our experienced attorneys are dedicated to helping you get full and fair compensation for all your losses. For that reason, we take all personal injury claims on a contingency basis. You won’t pay any legal fees unless we recover damages on your behalf.

There’s no charge to discuss your potential hernia mesh injury with us. Contact our experienced medical device injury trial lawyers today to schedule an appointment. We represent injured people throughout the United States.