Bayer’s Essure Contraceptive: What You Need to Know

Posted on Tuesday, August 14th, 2018 at 9:50 pm    

On Friday, July 20, Bayer AG, a German pharmaceutical and chemical company, announced it will cease selling its Essure medical device. Unsurprisingly, Bayer’s announcement was termed a “business decision” due to declining sales rather than the safety and efficacy of the device. In fact, Bayer cited “inaccurate and misleading publicity” as the primary reason for its decommercialization of Essure.

While the Essure device is itself unique, its tortured history is not unlike many implanted contraceptives that came before it. Indeed, the suffering of nearly 1 million women caused by the Dalkon Shield IUD in the 1960s and 70s served as the impetus for Congress’ passage of the Medical Device Amendments of 1976 (“MDA”). The MDA established for the first time comprehensive federal pre- and post-market regulation of medical devices.

What is the Essure Device?

  • Essure is a small, metal spring-like device wound with synthetic fibers designed for implantation in the fallopian tube to create a barrier of scar tissue to block sperm from reaching eggs.
  • Essure was developed by Conceptus, Inc., and FDA approved by the FDA in 2002. Bayer AG purchased Conceptus, Inc. in 2013, including the rights and liabilities associated with sales of Essure.
  • Since approval, the FDA has received nearly 30,000 reports of serious complications associated with the device, including migration and perforation of the device through tissue and organs, severe autoimmune response (fatigue, hair loss, weight gain), chronic pain and even death.
  • In 2015, the FDA held a public meeting with OB/GYN experts, concerned citizens and women injured by Essure.
  • In 2016, and due to continued complaints of complications and injury, the FDA required Bayer to conduct a clinical trial to test the safety and efficacy of Essure.
  • In October of 2016, the FDA demanded that Bayer add a “black box” warning to the Essure device.
  • In April of this year, FDA Commissioner Scott Gottlieb took the unprecedented step of imposing “unique” restrictions on the sale of Essure, including limiting the sale of the device to physicians who agreed to employ a “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” to ensure that the risks associated with the device were presented to prospective users prior to implantation.

What Do You Do if You Have Been Implanted with or Injured By Essure

  • Talk to your doctor to make sure you fully understand the risks of the device
  • If you’ve been injured by the device, consider seeking legal assistance now as your claim may be subject to strict time limits.

By Nate Vanderveer


The Dangers of IVC Filters

Posted on Thursday, July 12th, 2018 at 4:17 pm    

Have you suffered complications from an IVC filter? Contact the Birmingham defective medical device lawyers at Farris, Riley & Pitt, LLP today for a FREE case evaluation.


Understanding the Risks of Hernia Mesh

Posted on Monday, June 11th, 2018 at 5:39 pm    

Each year, more than a million patients undergo hernia repairs in the U.S. 1 Since the first use of mesh for hernia repair in 1948, the technique has exploded in popularity. Approximately 10 percent of groin hernia repairs are currently being done without mesh. 2 Though this technique is widely used, it’s not without risk. Hernia mesh complications have led to tens of thousands of legal claims, with complaints ranging from pain to infection. 3 You may be wondering – what is hernia mesh, and why is it linked to medical complications?

What Is a Hernia?

A hernia occurs when an organ, intestine or fatty tissue protrudes through a hole or weak spot in the muscle or connective tissue. Hernias typically occur at the abdominal wall, and may even appear as a bulge that sticks out from the skin. The most common types of hernia are:

  • Inguinal: inner groin
  • Femoral: upper thigh or outer groin
  • Incisional: through an incision or scar in the abdomen
  • Ventral: abdominal/ventral wall
  • Umbilical: belly button
  • Hiatal: inside the abdomen, along the upper stomach/diaphragm4

Most hernias are caused by pressure and an opening or weakness in the surrounding muscle and tissue. Sometimes this weakness is present at birth but it usually happens later in life. Causes of hernias include:

  • Obesity
  • Heavy lifting
  • Constipation/diarrhea
  • Persistent coughing/sneezing
  • Poor nutrition
  • Smoking

Treating Hernias

If you suspect you have a hernia, talk to your doctor. They will perform a physical exam to determine if you have a hernia. Coughing and straining can make it more prominent, so you’ll likely be asked to do this.

Once you’ve been diagnosed, your doctor will discuss treatment options. If your hernia is small and isn’t bothering you, your physician may suggest watchful waiting. They will watch the hernia over time and make sure it isn’t growing or causing problems.

Surgery is the only treatment to repair hernias. There are two options:

  1. Laparoscopy – This minimally invasive procedure allows your surgeon to operate through small incisions in your abdomen. Gas inflates your abdomen, making organs easier to see. A small tube equipped with a camera is inserted into one of the incisions, and the surgeon will insert tiny instruments through the other incisions to repair the hernia with mesh.
  2. Open hernia repair – Your surgeon will make an incision near the hernia, and push the protruding tissue back inside. They will sew it up and reinforce it with mesh.5

What Is Hernia Mesh?

Hernia mesh is a medical device surgeons use to provide extra support for the damaged tissue. It can be made of synthetic material or animal tissue, and comes in different sizes and shapes for different hernias.6

Hernia mesh is commonly used because it can lower the risk of a hernia recurring after the surgery. A 2014 study in the Journal of the American Medical Association compared conventional surgery, which uses sutures to repair the hernia, and surgery using hernia mesh. It found the rate of recurrence with suture repair is 8.2 percent, versus 2.7 percent for mesh repair.7 The study also linked mesh to higher rates of surgical site infection (SSI) and seroma, a pocket of fluid that forms near the incision and can lead to an infection.8

Hernia Mesh Complications

The use of hernia mesh is linked to other medical complications, such as:

  • Bowel obstruction
  • Migration of implant
  • Organ and tissue perforation
  • Scar-like tissue

While mesh is the preferred method for hernia repair, the long-term effects haven’t been widely studied. In 2016, researchers looked into complications, and found that 4.5 percent of patients who had their hernias repaired with mesh required additional surgery due to complications, as compared to just 0.8 percent of patients who had their hernias repaired without mesh. The study also found that the larger the mesh used, the greater the risk for complications.9

Hernia Mesh Recalls

Many hernia mesh complications reported to the Food and Drug Administration are linked to recalled products. In April 2018, the FDA recalled Versatex™ monofilament mesh made by Sofradim Production due to patient reports of hernia recurrence after surgery.10 The FDA has recalled more than a dozen hernia mesh products since 2013 due to risk of complications.11 You can find a full list of medical device recalls on the FDA website.

Hernia Mesh Lawsuits

Patients suffering from hernia mesh complications who have filed lawsuits allege that manufacturers were aware of the dangers their products pose and didn’t properly warn doctors and patients of potential complications. Many of these products are included in FDA adverse event reports. As recently as 2017, patients reported that Ethicon’s Physiomesh™ was breaking into pieces or rupturing after surgery and causing bowel obstruction.3

As of May 2018, there are more than 1,200 lawsuits against two hernia mesh manufacturers pending in federal multidistrict litigations (MDLs). Trials are expected to begin in 2019.12

If you’ve experienced a hernia mesh failure following surgery using mesh since 2007, are experiencing complications and you had or have scheduled hernia revision surgery, you could also have a case.13

Hernia mesh manufacturers have been found liable for hundreds of millions of dollars in lawsuits. The amount you will receive varies depending on your case. Any damages awarded will provide compensation for:

  • Medical expenses
  • Lost income
  • Pain and suffering

Compensation for Hernia Mesh Complications in Birmingham, AL

If you or a loved one have suffered complications from hernia mesh, but aren’t sure how to begin the process of filing a lawsuit, the team at Farris, Riley & Pitt, LLP can help. Our attorneys have extensive experience advocating for victims of defective medical devices, and we’re dedicated to getting you the money you deserve.

Call us anytime at (205) 324-1212 to get your FREE case evaluation.

1https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm

2https://www.laparoscopic.md/surgery/instruments/surgical-mesh

3https://www.consumersafety.org/legal/hernia-mesh-lawsuit/

4https://www.webmd.com/digestive-disorders/understanding-hernia-basics

5https://www.mayoclinic.org/diseases-conditions/inguinal-hernia/diagnosis-treatment/drc-20351553

6https://www.drugwatch.com/hernia-mesh/

7https://jamanetwork.com/journals/jamasurgery/fullarticle/1828521

8https://www.healthline.com/health/seroma#complications

9https://jamanetwork.com/journals/jama/fullarticle/2565771

10https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162927

11https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

12http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-May-15-2018.pdf

13https://www.classaction.com/hernia-mesh/lawsuit/


Understanding the Risks of Transvaginal Mesh

Posted on Monday, June 11th, 2018 at 4:58 pm    

If you’ve watched cable TV in the past several years, chances are, you’ve seen a warning about transvaginal mesh pop up on your screen. This may have left you wondering, what exactly is transvaginal mesh, and why is it causing problems?

What Is Transvaginal Mesh?

Transvaginal mesh is exactly what it sounds like – a netted material that is inserted through the vagina. The mesh can be made from plastics and polyesters (usually polypropylene), disinfected cow or pig tissue or a mix of synthetic and natural materials. Its primary purpose is to strengthen weakened tissue for better organ support.

Generally, transvaginal mesh is used as a treatment for two common issues:

  • Pelvic organ prolapse (POP) – When organs such as the uterus, bladder, urethra, bowel and rectum are no longer supported by the pelvic tissues, they begin to bulge into the vagina, distorting its shape and putting pressure on it. Transvaginal mesh can be inserted along the front, top or back of the vagina to support the surrounding organs and reduce symptoms.
  • Stress urinary incontinence (SUI) – A condition where a person accidentally urinates when physical stress is put on the bladder or urethra. This could happen when laughing or sneezing, or it could result from physical activity like exercise or bending. SUI occurs when the pelvic floor muscles and urinary sphincter weaken. A bladder sling or vaginal tape made of transvaginal mesh can support the bladder and urethra.

Who Is Most Likely to Have Transvaginal Mesh Surgery?

Women in their 40s and beyond are most likely to have undergone transvaginal mesh surgery. This is because POP and SUI often result from tissue trauma that happened during childbirth. Tissues also tend to weaken with age, and menopause can increase the effects. Obesity can also exacerbate symptoms due to the additional pressure put on the pelvic tissues.

Those who have had a hysterectomy can also be susceptible to POP, SUI and similar issues. When such a large organ in the reproductive system is removed, the vagina can become misshapen and its walls can collapse.

Is Transvaginal Mesh Unsafe?

Though transvaginal mesh has been used since the 1970s and is based on hernia repair mesh originating in the 1950s, it poses significant risks, including:

  • Mesh erosion (including protrusion of the mesh from the vaginal walls)
  • Scarring, tightening and shrinkage of the vagina
  • Pain, especially during sex
  • Unexpected bleeding
  • Nerve and muscle problems
  • Organ perforation, which often requires surgery to fix

Recent data suggests that anywhere between seven and 21 percent of patients have complications with a transvaginal mesh procedure.1 The Food & Drug Administration (FDA) stated that complications from transvaginal mesh are “not rare” in 2011 and then reclassified transvaginal mesh from a class II, moderate-risk device to a class III, high-risk device for POP in 2016.2,3 Transvaginal mesh is banned in New Zealand and partially banned in Australia and the U.K., but allowed in the U.S., where it is still offered by many medical professionals.

What Are Some Alternatives to Transvaginal Mesh?

Fortunately, many women who have POP and SUI experience little to no disruption in their everyday lives. This means they can potentially go without any treatment. Those who do experience symptoms may wish to try:

  • Muscle exercises – Kegels and similar exercises help re-strengthen the pelvic floor and reduce mild symptoms.
  • Pessaries – These small, specially fitted silicone devices shaped like an arch, ring or disc are placed inside the vagina for additional support.
  • Urethral inserts – These devices physically block the flow of urine out of the body, which may be helpful for those with SUI who don’t wish to avoid physical activity for fear of embarrassment.
  • Estrogen treatments – Menopause can cause or worsen POP, and some women may benefit from supplemental estrogen to manage their symptoms.
  • Surgeries without transvaginal mesh – A medical professional can use the patient’s own tissue to create support instead of using plastic, polyester or animal tissue. While the initial surgery poses higher risks, long-term complications are far less likely.

Compensation for Transvaginal Mesh Complications in Alabama

The FDA and medical device manufacturers have cut corners when it comes to testing, manufacturing and approving transvaginal mesh products. Unfortunately, this has led to many health issues caused by defective products all over the country.

If you or a loved one has suffered complications and additional health care costs from transvaginal mesh, you may be entitled to financial compensation. At Farris, Riley & Pitt, LLP, our attorneys work hard to get you the money you deserve. Call us any time at (205) 324-1212 for your FREE case evaluation.

1https://www.drugwatch.com/transvaginal-mesh/

3https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm


Identifying and Preventing Elder Abuse and Neglect

Posted on Monday, May 7th, 2018 at 6:10 pm    

As our loved ones age, they may begin to struggle to perform daily activities such as bathing, changing clothes, cooking or taking medications. In situations like these, they may require a caregiver – either in-home or in a community – who can care for them and fulfill their daily needs at all hours. However, due to their frailty and inability to complete normal functions without assistance, seniors who have caregivers are often a target for abuse or neglect. (more…)


A History of Defective Medical Devices

Posted on Friday, March 9th, 2018 at 7:50 pm    

Many medical devices manufactured for public use work well and pose little to no risk to the general public when used as prescribed, but the success rate is nowhere near perfect. Even the most well intentioned medical professionals can do more harm than good by using faulty medical products while treating patients. (more…)

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