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Essure Birth Control Pulled from U.S. Market

What They Knew, When They Knew It

Essure Birth Control and Serious Injuries

Kids are a blessing but they are also a lot of work. Maybe your family is complete and you were looking for a way to prevent additional pregnancies. Or it could be that you have a fulfilling career and homelife and motherhood just isn’t for you. There are many reasons why women have looked to Essure birth control to prevent pregnancies, but now they need to be aware of the serious injuries that are being reported after using this potentially harmful medical device that was voluntarily recalled by Bayer in July 2018.

What They Knew

Essure birth control was put on the market by Bayer in 2002. One of the problems with this medical device is that it’s 55% nickel which causes an allergic reaction in approximately 20% of women. This allergic reaction triggers the immune system and presents like an autoimmune disease with rashes or eczema, chronic pain, brain fog, muscle weakness, hair loss and more. An additional problem is that Essure can break and migrate causing perforations to other tissues and organs causing pain and bleeding. Furthermore, there have been approximately 631 pregnancies and 294 miscarriages or stillbirths after using this product which proves that this device isn’t foolproof. Four deaths have also been reported that are being linked to the adverse effects of an Essure implant.

When The Knew It

Clearly Bayer knew their product was made out of nickel from the beginning and that this metal posed the potential for adverse immune reactions in the body. In 2012, a group of women demanded a meeting with the FDA to share their painful stories of how Essure robbed them of their health. In September 2015, a special hearing was conducted by the FDA who listened to the testimonies of 22 women describing how Essure complications affected their relationships, sex lives and everyday health. In February 2016, the FDA required that Bayer put a black box warning (the highest warning available) onto Essure and also now requires that doctors review a patient checklist which includes potential side effects and outcomes. Nevertheless, Bayer knew from the beginning that a large percentage of women were allergic to nickel and never warned or suggested testing to avoid these harmful results. Additionally, for over five years the FDA and Bayer knew that Essure was harming thousands of women and failed to warn others of the potential for pain, future surgeries and other complications.

What Can You Do?

Currently, more than 5,200 women have petitioned to sue Bayer because of the pain and suffering they endured due to Essure implants. If you are like these women, you may be able to make a claim against Bayer if after having an Essure medical device inserted you:

  • experienced a perforation of the uterus or fallopian tubes
  • had your device migrate putting your health at risk
  • had an unintended pregnancy
  • endured hospitalization as the result of an allergic reaction to nickel
  • had surgery to remove your Essure device – including a hysterectomy – or have a surgery scheduled to remove this device

Bayer continues to claim that this device is safe and that its market removal was due to low sales, but clearly Essure puts women’s lives and their future at risk. Sales were potentially low because of the number of studies that showed the ineffectiveness of Essure and the likelihood of additional surgeries due to complications.

It’s time that we speak out and hold pharmaceutical companies responsible for their carelessness and the painful injuries that they are causing in countless women. You’ve undoubtedly suffered and may have high medical bills or have been unable to work and you lost needed wages. Please contact us today to see if you are able to get the financial compensation that is owed to you.

 

Essure Warnings In The News

BREAKING (7/27/18): CNN Exclusive: Bayer paid doctors millions for questionable birth control device

When Christina Potts was looking for permanent birth control, she said, her doctor was a “cheerleader” for one option and one option only: Essure.

Potts says the device, which is implanted in a woman’s fallopian tubes to block sperm from reaching an egg, left her in terrible pain and extremely fatigued. It was so bad that she had a hysterectomy, removing her uterus and tubes to get rid of Essure.

Read Full Article

 

BREAKING (7/21/18): Essure Birth Control Pulled From U.S. Market

Bayer announced that by the end of this year, they will be no longer selling Essure birth control to the U.S. market. Bayer sites that the reason for this decision was, “based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” However, there has been much concern over the safety and effectiveness of this medical device causing the U.S. to be the last country where this product was sold.

Read Full Article

BREAKING (7/20/18): Sales of Essure birth control implant halted by Bayer; U.S. was last to sell controversial device

Pharmaceutical giant Bayer said Friday that it will halt sales of its controversial Essure birth-control device in the United States at the end of the year, bringing to a close a protracted battle over an implant that thousands of women blame for serious problems, including persistent pain and perforations of the uterus and fallopian tubes.

In a statement, the company said, “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” It said it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.

Read Full Article

4/9/18: Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution

The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.

On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation.

Read Full Article

4/1/18: This Birth Control Device Kept Making Women Sick. The FDA Kept It On The Market.

Last month, Food and Drug Administration Commissioner Scott Gottlieb met with a group of women who’ve been knocking on the agency’s door for years.

Online, they’re known as E-sisters: women who were implanted with the permanent “non-incisional” contraceptive called Essure, which consists of metal coils that are implanted into the fallopian tubes and contain nickel. The E-sisters believe Essure has caused them ― and tens of thousands of others ― a constellation of health problems, from bleeding, bloating and pelvic pain to more obscure symptoms like rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction.

Read Full Article

8/23/17: FDA Warning: Essure Permanent Birth Control

Essure is a a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.

Read Full Article

2/29/16: FDA Orders ‘Black Box’ Warning Label on Essure Long-Acting Contraceptive

A special “black box” warning should be added to packaging for the Essure implantable birth control device, based on concerns over serious complications, the U.S. Food and Drug Administration announced Monday.

The FDA also ordered Essure’s manufacturer, Bayer, to conduct a new clinical study to gather more data about the health risks the device might pose for “in a real-world environment.” Essure is a permanent and nonsurgical form of birth control for women. It consists of flexible coils that are inserted through the vagina and cervix into the fallopian tubes, the FDA explained in a statement.

Read Full Article

Filed Essure Complaints & Damages

5/5/16: Bailey V. Bayer Corp. Et Al

This Complaint is brought by Plaintiffs who relied on express warranties of Defendants before being implanted with a female birth control device, known as “Essure.” In short, the device is intended to cause bilateral occlusion (blockage) of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage.

This Complaint is brought by Plaintiffs with respect to the same occurrence (implantation of Essure, reliance on the same representations prior to implantation, Defendants’ failure to warn Plaintiffs of the same adverse events, and subsequent injuries due to Essure) and which has several questions oflaw and/or fact common to all Plaintiffs.

Read Full Case

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Essure Birth Control Tied To Serious Injuries

Bayer recently announced that they will no longer sell Essure birth control in the United States by the end of 2018. They claim a fall in sales, but facts prove otherwise.

To get more information on the dangers of Essure, or learn if you could be eligible to receive compensation for your losses, call 1-800-844-0246 now.

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5 Little Known Facts About Essure

Did you know that thousands of women have had hysterectomies due to bad Essure implants? If you have this medical device, find out what warning signs to watch for to protect your health.

If you or a loved one have been harmed by Essure, call (800) 511-3838 now to see how we can help.

GET YOUR FREE Essure CASE REVIEW TODAY

Essure settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

The Link Between Medical Implants and Autoimmune Diseases

Fatigue. Brain fog. Fibromyalgia. Most people don’t associate these symptoms with having a medical device, but doctors and researchers have been finding a very strong link between the two. From patients who have breast implants to those with surgical mesh or knee replacements, countless people are struggling to battle autoimmune diseases resulting from their implants and yet have no idea why they’re feeling so sick.

The Link Between Medical Implants and Autoimmune Diseases

Types of Autoimmune Diseases

An autoimmune disease is when the body attacks and damages its own tissues. An autoimmune disease can be associated with materials used in medical implants, devices, and adjuvants (substances added to vaccines such as aluminum and mercury). Here are just a few of the common types of autoimmune diseases that have been linked to medical implants:

  • Chronic Fatigue Syndrome (CFS) – This condition can also be called systemic exertion intolerance disease (SEID) or myalgic encephalomyelitis (ME). Loss of memory or concentration, unexplained muscle or joint pain, headaches, and unrefreshing sleep are characteristics of CFS.
  • Fibromyalgia – Pain, stiffness, tenderness, and soreness in the muscles at “trigger points”.
  • Multiple sclerosis – A disabling disease of the central nervous system that disrupts the flow of information within the brain and between the brain and body.
  • Rheumatoid arthritis – An inflammatory condition that results in warm, swollen, and painful joints
  • Systemic lupus – The body’s immune system starts to attack healthy tissue and may cause  painful and swollen joints, fever, chest pain, hair loss, and more.
  • Crohn’s Disease – This inflammatory bowel disease can affect any part of the gastrointestinal tract from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea, fever, and weight loss.

Types of Medical Implant Materials

Depending on the injury or treatment needed, there are many different types of materials used.

Biologic

Biologic material is derived from living tissue, which can include intestines or skin that has been processed and disinfected for use as an implant device (for example, pig skin has been used instead of plastic mesh to reinforce hernias). The tissue is sourced from pigs, cows, sheep or humans. The most important specification for a biological material is that it’s biocompatible which means that it’s able to integrate into a host without causing an immune reaction. The pros are that they are more compatible with your body. The cons include that they can break down and degenerate.

Let’s say you had breast cancer and you wish to reconstruct your breast using your own tissue. A surgeon would take tissue from your stomach, thighs or buttocks to rebuild your breast instead of using saline or silicone which have been linked to cancers and other health conditions.

Synthetic

Obviously “synthetic” is something that doesn’t occur naturally and synthetic devices can include plastics, ceramics, porcelain, and other man-made materials. These are commonly used for dental implants, sutures, hernias, and more. Ceramics are even being used in joint replacements to “reinforce it and provide improvements to the bicompatibility, joint wear and mechanical properties,” explains researcher Ana Maria Arizmendi Morquecho. The pros are that synthetic materials can be cheaper, more readily accessible, and last longer than biologics. The cons are that they can cause autoimmune disorders in the body and many times the products aren’t fully tested before being put on the market. Transvaginal mesh (TVM) is one example that left countless women worldwide with multiple health complications that cannot be resolved. TVM is made out of a plastic called polypropylene that can erode in the body, migrate, and the sharp edges can sever tissues and organs.

Metal

Metals are commonly used in implants and titanium and metal alloys are often found in hip replacements and other similar implants. These products are many times used in combination with synthetic materials to mimic bone and tissue function. While they are long lasting, many people experience autoimmune disorders since the immune system may fight a foreign object in the body. Essure was a popular permanent birth control device that was designed to be implanted in the fallopian tubes. It was made out of 55% nickel. The problem is that 20% of women are allergic to nickel and had serious reactions due to this device.

How the Body May Respond to an Implant

Medical implants can be made from a variety of materials depending on the injury or issue it is supposed to address. However, each person can react differently to each material. Here are some recent studies linking autoimmune diseases with common medical implants:

Breast Implants

In January 2019, a study was published in Clinical Rheumatology that stated that silicone may trigger immune responses that increase the risk of developing fibromyalgia and CFS. “Researchers studied 30 female patients, 47.9 years old on average, treated between 2000 and 2017, who received silicone breast implants before being diagnosed with a rheumatological condition,” explained Fibromyalgia News Today. “Overall, six patients were diagnosed with fibromyalgia, three with chronic fatigue syndrome, and 12 with depression; the remaining patients were diagnosed with other conditions, such as Sjögren’s syndrome and rheumatoid arthritis.”

Transvaginal Mesh (TVM)

Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta, noticed that many of his patients were experiencing the same health problems after having vaginal mesh surgery. “In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as ‘brain fog, muscle and joint pain ‘fibromyalgia, feverish temperature, and dry eyes and dry mouth,” Tervaert said. “Of those patients, 45% developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”

Essure

Essure was introduced to the market in 2002 and was supposed to be a permanent, drug free birth control device for women. This coil-like implant was placed in the fallopian tubes so that eggs cannot descend from the ovaries into the uterus to be fertilized. However, Essure is made out of 55% nickel and 20% of women are allergic to this metal. According to the FDA, “From 2002 through 2017, the most frequently-reported patient problems were pain/abdominal pain (21,215), heavier menses/menstrual irregularities (9,846), headache (7,231), fatigue (5,842), and weight fluctuations (4,970). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient-device incompatibility example, possible nickel allergy (4,481), migration of the device or device component (2,936), dislodged or dislocated device (1,356), device breakage (1,044), device operating differently than expected (947), device difficult to remove (331), device difficult to insert (317), and malposition of the device (279).”

What You Need to Know About Medical Implants

One of the biggest problems with medical implants is that patients don’t know that they’re linked to autoimmune disorders. After all, how can a hip replacement cause brain fog? However, there IS a strong connection between the two and patients need to know the symptoms to look for to determine if they’re having a negative reaction to their medical device. While the implant or device may not always be able to removed or replaced, having some answers may help you to address the symptoms more effectively.

 

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Sources
“Mesh devices may be to blame for autoimmune symptoms” Medical Plastics News. Accessed March 1, 2019. https://www.medicalplasticsnews.com/news/medical-devices/mesh-devices-may-be-to-blame-for-autoimmune-symptoms/?fbclid=IwAR2fl6djkplrWEM3YqrzkHf2_Ob0vy2mqHoViraEh71P5jXNMLoByx2SoqU
“Chronic fatigue syndrome”. Mayo Clinic. Accessed March 7, 2019. https://www.mayoclinic.org/diseases-conditions/chronic-fatigue-syndrome/symptoms-causes/syc-20360490
“Silicone Breast Implants Tied to Fibromyalgia, But More Evidence Needed, Study Says”. Fibromyalgia News Today. Accessed March 7, 2019. https://fibromyalgianewstoday.com/2019/02/13/silicone-breast-implants-fibromyalgia-more-evidence-needed/
“FDA Activities: Essure”. FDA. Accessed March 11, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm#s5
“Biological Materials Information”. Engineering 360. Accessed March 13, 2019. https://www.globalspec.com/learnmore/specialized_industrial_products/pharmaceutical_biotechnology/biotechnology/biological_materials
“Scientist look for nanostructures that allow compatibility between metal, human bone tissues”. Nanowerk. Accessed March 14, 2019. https://www.nanowerk.com/nanotechnology-news/newsid=38577.php

Do You Have an IVC Filter? Here’s What’s Happening in the News

This month IVC (interior vena cava) filters have been in the news quite a bit lately as lawsuits are settling and more claims are being filed. If you or a loved one has an IVC filter, here are the important updates that you should know about this controversial medical device.

Do You Have an IVC Filter? Here's What's Happening in the News

The Problems Linked to IVC Filters

For those who are at risk for blood clots and are unable to take blood thinners, IVC filters are placed in a large vein called the interior vena cava. The filter is made up of several metal prongs that connect at one end (almost like the frame of a closed umbrella). The hope is that the device will catch any blood clots and prevent them from traveling to the heart or lungs where it could cause extensive damage or even death.

The problem with the filter is that reports have been made to the FDA stating that the device can move causing it to puncture the interior vena cava. This device may also have prongs break off causing the pieces to migrate to other parts of the body creating excruciating pain and putting patient health at risk.

Lawsuit Finds in Favor of Patient with IVC Filter

Just last month an Indiana woman went to trial and won her case against IVC filter manufacturer Cook Medical. 53-year-old Tonya Brand of Snellville, Georgia, had an IVC filter surgery in 2009 and in 2011, a prong from her filter had migrated and pushed through the vein and the skin of her thigh. Other parts had also broken off and migrated throughout her body but are unfortunately unable to be removed. After deliberating for 11 hours, the jury decided that Brand should receive $3 million to help pay for the financial hardships that her injuries have caused.

This is a landmark verdict for patients who have had similar problems with their IVC filters; this is the first case where it was decided that this kind of device has a defective design. This is also the highest monetary compensation that has been awarded for this type of case (a Texas state court jury awarded $1.2 million against Cook Medical in a failure to warn case in 2018).

Upcoming Case to Watch

The newest and most notable lawsuit concerning IVC filter injuries was filed on February 26, 2019 in the U.S. District Court for the District of Arizona. This case is said to involve a woman from Missouri who was injured by the G2® Vena Cava Filter (“IVC Filter”) manufactured by C.R. Bard and Bard Peripheral Vascular, Inc. The crux of this case is based on the issue that C.R. Bard sold a defective medical device and failed to warn about safety risks. Currently, there are 6,300 actions pending in this case. This means that instead of taking each filed lawsuit to trial, the verdict of this case will help to determine the outcome and compensation of the thousands of similar cases brought against C.R. Bard.

Should You File a Claim?

There are now over 9,000 IVC filter lawsuits pending against IVC filter manufacturers Johnson & Johnson, Cook Medical, Cordis Corporation, Rex Medical, C.R. Bard, B. Braun and more. Clearly, hundreds of thousands of people had their lives put in jeopardy and thousands suffered from the terrifying effects of their broken filters. Profits were put before people and if you were injured, you should consider filing a claim to receive financial compensation due to high medical bills, lost wages, and other monetary hardships that you had to endure.

If you had an IVC filter placed in your body between 2005 – 2017 and had it break or migrate, call Periscope Group today at (800) 511-3838. We want to hear your story.

 

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Sources
“Indiana Jury Awards $3M in IVC Filter Lawsuit”. Legal Scoops. Accessed March 13, 2019. https://www.legalscoops.com/indiana-jury-awards-3m-in-ivc-filter-lawsuit/
“Indiana Jury Awards $3M in Cook IVC Filter Bellwether Trial”. Yahoo! Finance.  Accessed March 13, 2019. https://finance.yahoo.com/news/indiana-jury-awards-3m-cook-040408228.html

 

Study Finds 45% of Mesh Implant Patients Develop Autoimmune Disorders

Surgical mesh is often used in hernia repairs and in American women for stress urinary incontinence and pelvic organ prolapse (it’s illegal in other countries to treat gynecological issues). These medical devices have been linked to complications due to mesh erosion which can cause migration, organ perforation, bleeding, and other serious issues. A new study was recently published that also linked surgical mesh to a high rate of autoimmune disorders. If you have surgical mesh or are considering a procedure that uses a medical device implant, here is the information that you need to know.

Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta, closely monitored his patients and came to a shocking conclusion, “In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as ‘brain fog,’ muscle and joint pain ‘fibromyalgia,’ feverish temperature, and dry eyes and dry mouth,” stated Dr. Cohen Tervaert. “Of those patients, 45 per cent developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”

The Problem with Medical Device Implants

Unfortunately, complications can arise when any foreign object is inserted into the body. Similar symptoms have been frequently reported in patients who have silicone breast implants. “When a foreign body is put into the body, there is an instant activation of the immune system. It continues to fight the foreign body and eventually, over time, fatigues and becomes dysfunctional,” Dr. Cohen Tervaert explains. “Large-scale studies have shown that patients with breast implants have more symptoms of ASIA (autoimmune/auto-inflammatory syndrome induced by adjuvants) and an increased risk to develop an autoimmune disorder.

Doctors have determined that patients are genetically determined whether or not they’ll have an adverse autoimmune reaction to their medical device. Dr. Cohen Tervaert found that pre-existing allergies were present in 80% of breast implant patients which just so happened to be the same percentage of patients who had allergies in his patient group involving mesh. While it seems like an obvious answer is to have patients genetically tested for allergies before having a medical device implanted, unfortunately a test like this does not yet exist.

Many patients recovered after having the medical device removed in situations involving breast implants, but this type of surgery is more complicated with surgical mesh. Tissue and nerves can grow in and around the mesh making it virtually impossible to take out the entire device for countless patients.

Discussing your concerns with your doctor and carefully weighing the risks versus the benefits are two ways to protect your health. Also, familiarize yourself with the symptoms associated with autoimmune disorders. The sooner you call your doctor to address these issues, the better chance you have at recovery.

 

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Sources
“Surgical mesh implants may cause autoimmune disorders”. Medical Xpress. Accessed December 20, 2018. https://medicalxpress.com/news/2018-07-surgical-mesh-implants-autoimmune-disorders.html?fbclid=IwAR0cIcQsQyMQBaTwBCdv5q-kExUEkzteXXX9q9cDVby4VyOTHgcvbgF3qH8

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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