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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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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

FDA Approves 1000X Stronger Opioid in the Midst of Addiction Crisis

We’ve all heard about the Opioid Crisis and maybe you’ve even had your doctor reduce or halt your prescription of Vicodin, Percocet, or Tylenol with Codeine (to name a few) in recent years.

Ironically, as prescriptions are decreasing concerning this highly addictive medication, the FDA has just approved Dsuvia, an opioid that is five to 10 times stronger than fentanyl and 500 to 1000 times more powerful than morphine.

Doesn’t this seem counterproductive to solving this drug epidemic that plagues the U.S.?

FDA Approves 1000 X’s Stronger Opioid in the Midst of Addiction Crisis

What is Dsuvia?

Dsuvia is made by AcelRx Pharmaceuticals, Inc. and is intended for “the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate,” explains Dr. Pamela Palmer, anesthesiologist and chief medical officer at AcelRx.

This new drug comes in pill form and is intended to dissolve under the tongue. Additionally, since it is such a potent medication, it’s only supposed to be distributed and monitored in medical settings to prevent drug abuse.

Other regulations include that a patient may only be on Dsuvia for 72 hours and the prescription will be required to have the same black-box warnings as all opioids concerning the risk of abuse, addiction, and overdose (but who reads a label when you’re admitted in a hospital?).

The Problem with Dsuvia

Opioid abuse has been rampant in the U.S. and offering a new opioid that is significantly stronger may only add fuel to the fire.

“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year,” stated Dr. Raeford Brown, chair of the FDA advisory committee on analgesics and anesthetic drug products. “The need to put a drug like this on the market is not demonstrated.

The ability to manage that drug once it gets past the FDA is not demonstrated…. We know from looking at other potent opioids that have been put on the market in the last four years that once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market.”

More than 115 people die each day in the U.S. from an opioid overdose and opioid misuse costs our country approximately $78.5 billion a year. It seems obvious that offering a stronger drug will only create larger problems, especially when the FDA lacks the funding and manpower to perform post-market monitoring.

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Sources
“Amid deepening addiction crisis, FDA approves powerful new opioid”. CNN. Accessed November 5, 2018. https://www.cnn.com/2018/11/02/health/new-opioid-dsuvia-fda-approval-bn/index.html
“What is Dsuvia? What you should know about the new opioid drug that’s 10 times stronger than fentanyl”. ABC News. Accessed November 5, 2018. https://abcnews.go.com/Health/dsuvia-opioid-painkiller/story?id=58875487
“FDA ADVISORY COMMITTEE BRIEFING DOCUMENT”. FDA. Accessed November 5, 2018. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622858.pdf
“Opioid Overdose Crisis”. National Institute on Drug Abuse. Accessed November 5, 2018. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis

California’s Deadly Camp Fire: How To Receive Financial Support

Once again fires have ravaged California’s forests and have left a multitude of residents displaced. Acres have been destroyed, there is just a charred footprint where thousands of homes once existed, and residents are shocked and wondering how will they ever pick up the pieces to their now broken lives. And for the fourth time in 12 months, faulty electrical equipment has been linked to the devastation.

California’s Deadly Camp Fire: How To Receive Financial Support

While all of the fires in the past year have touched our hearts, “Camp Fire” has hit one of our own team members here at Periscope Group. Laura, the manager of our Call Center, has been busily gathering clothes, toiletries, and other essentials for her parents who lost their home in Paradise, CA. This is their story.

Chris and Jenny’s Story

Chris and Jenny bought their retirement dream home in July 2018 off of Pentz Road in Paradise, CA. Just months later, on November 8, Chris walked outside and quickly noticed that the fire was so close that he could see the smoke swirling at the base of the flames. Just ten minutes later, Chris and Jenny tossed two backpacks containing three days’ worth of clothes, the contents of their safe, their two dogs, and a two-drawer metal filing cabinet into their cars. Chris advised Jenny to “make sure your bumper is touching my bumper the whole way down.” Amidst ash, flames, and wind, they desperately hurried to escape the quickly moving firestorm. Jenny would later describe it as moving through a “Biblical hell.”

They escaped to Chico to find refuge with a relative only to be relocated later that night since the fire was quickly spreading. They moved on to stay with Chris’ aunt who lives in Live Oak.

On the Sunday after their escape, a next door neighbor who was a city official went on an escorted expedition to find out what remained of her home. To her shock and heartbreak, her home had been leveled by the fire along with all of the neighboring homes… including Chris and Jenny’s.

Chris and Jenny have decided not to rebuild. Paradise is unique as compared to some of the other California fire locations in that it’s more of a “mom and pop” type town. There are no big businesses that will start over and many people don’t have the resources to pick up where the fire left off.

Other than the few items that they piled in the car, Chris and Jenny are now left with nothing. Photographs, childhood memories, and their dreams of retiring in Paradise have been reduced to ash. The emotional devastation has been as painful as the physical one.

How Could This Happen… Again?

While Chris and Jenny’s story is upsetting, they are in no way alone in this struggle to rebuild. Three fires last year – Butte, Tubbs, and Thomas – caused hundreds of thousands of acres to be wiped out, cost hundreds of millions of dollars, destroyed over 8,000 structures (most were private homes), and 25 people died. The current Camp Fire exceeds even these tragic numbers. As of November 13, 6,522 residential structures and 260 commercial buildings have been destroyed, 120,000 acres have been burned, and 42 people have lost their lives making this the largest and deadliest fire in California history.

What else do these fires have in common? All of them have been linked to malfunctioning equipment owned by PG&E or Southern California Edison (SCE). In this recent Camp Fire, an Electric Safety Incident Report stated that, “On November 8, 2018, at approximately 0615 hours, PG&E experienced an outage on the Caribou-Palermo 115 kV Transmission line in Butte County. In the afternoon of November 8, PG&E observed by aerial patrol damage to a transmission tower on the Caribou-Palermo 115 kV Transmission line, approximately one mile north-east of the town of Pulga, in the area of the Camp Fire.”   

What Can You Do About It?

We know that if you’re in this situation, you’re probably feeling heartbroken, devastated, lost, confused, and so much more and we want to help. Our legal team has assisted countless people who have lost everything due to mass fires and they can sort through insurance forms and other crucial paperwork to get the funding owed to you. Call (800) 511-3838 or contact us to speak with our Call Center today (and you can even request to speak to Laura!). We want to help you in any way we can.

 


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Image Source: KQED News

 

Is Your Doctor on Probation? Most Patients Don’t Know

Most patients either call their doctor’s office or visit a website to make an appointment. We think about what health complaints we want to share, write down any questions we may have, and just hope that we don’t have to sit in the waiting room too long.

Is Your Doctor on Probation? Most Patients Don’t Know

However, have you ever consider if your doctor ever had to undergo disciplinary action for sexual misconduct or for improperly prescribing a drug? After all, if they committed a crime like this and caught, wouldn’t their medical license be taken away? Not necessarily. Is your doctor on probation for misconduct?

The New California Law

It’s horrible that so many women have been assaulted, but a plethora of good has come from the female Olympic athletes who spoke out against their team doctor and the women who voiced their stories in the #MeToo movement.

One example of progress can be found in the new California law enacted in September 2018 called the Patient Right to Know Act. This law states that physicians are required to inform patients when they were put on probation for harming those under their care. There is already a public directory in place that shares this information, but most patients are unaware of its existence (if your doctor is in California, you can look for your doctor’s name here. For other states, conduct a Google search that says, “how can I find out if my doctor is on probation in {your state here}?” The website for your medical board should appear.)

With this new law in place, physicians on probation after July 1, 2019, are required to alert clients about their status before an appointment.

Doctors may be put on probation for the following reasons:

  • Sexual misconduct against a patient
  • Drug abuse that can be harmful to patients
  • A criminal conviction which resulted in harm to patients
  • Inappropriate prescribing resulting in patient harm

“It’s never made sense that doctors have had to tell their insurance companies, hospitals and clinics when they are put on probation, but not the people who are most at risk — their patients,” stated Lee Harris, president of the Consumer Attorneys of California.

According to the LA Times, surgeons, osteopaths, naturopathic doctors, chiropractors, podiatrists and acupuncturists are also bound by the new law.

The relationship between you and your doctor is important and you need to feel safe, heard, and cared for to receive the optimum care that you deserve. If you don’t feel this way about your doctor, it may be time to search for a new one. Furthermore, this only affects California. We think other states should follow their lead.

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Sources
“California doctors must tell patients if put on probation for sexual misconduct under new law”. LA Times. Accessed October 31, 2018. http://www.latimes.com/local/lanow/la-me-ln-doctor-probation-law-20180920-story.html
“New Law Requires Doctors on Probation to Disclose Discipline to Patients”. NBC San Diego. Accessed October 31, 2018. https://www.nbcsandiego.com/news/local/New-Law-Requires-Doctors-to-Disclose-Past-Discipline-to-Patients-493909811.html

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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