July 2018 Update: Citing a decrease in sales, Bayer announced it would end the sale and distribution of Essure in the U.S. by December 31, 2018. Since hitting the market in 2002, the FDA received nearly 30,000 Essure adverse event reports and reviewed another 20,000 online complaints about the device. The government agency slapped a sales restriction on the device in April and Bayer is facing more than 16,100 lawsuits pending in state and federal courts across the country. Read More About the Withdrawal.
The Facts about Essure
Table of Contents
- 1 The Facts about Essure
- 2 Important Warning Video
- 2.1 What is Essure?
- 2.2 What is the implant made of?
- 2.3 Was it approved by the FDA?
- 2.4 What is the procedure?
- 2.5 Can Sterilization be Reversed?
- 2.6 What are the Side Effects?
- 2.7 Have Women Complained about Adverse Events?
- 2.8 Controversy Surrounding Clinical Trials
- 2.9 Essure Black Box Warning
- 2.10 Essure Sales Restriction
- 2.11 Are There Lawsuits?
For thousands of women, the Essure Permanent Birth Control System seemed like a safe alternative to having your tubes tied. After all, it’s a permanent birth control solution that can be performed in a doctor’s office without the need for general anesthesia. Little did patients know that the Essure coils could cause chronic pain, heavy bleeding, painful intercourse, and even force you to have to undergo surgery to have the device removed when it migrates from the fallopian tubes to elsewhere in the body, possibly perforating organs.
Important Warning Video
What is Essure?
Essure is a permanent form of birth control that is sold by prescription only. It doesn’t contain hormones, is non-reversible, and the procedure to implant the device can be performed in your physician’s office instead of in a hospital under general anesthesia. Your physician will perform the hysteroscopic sterilization by inserting two small metal coils into the fallopian tubes to prevent pregnancy. The implants work by creating scar tissue that blocks the sperm from being able to fertilize the egg. Reports show that nearly 900,000 women have been implanted with the Essure device.
What is the implant made of?
Essure is a micro-insert that is about 40 mm long with a diameter of about 2 mm after it expands. The coils are made of polyethylene terephthalate fibers wound around a stainless steel inner coil surrounded in a nickel-titanium alloy. The coils will release small amounts of nickel into the body, so women who are allergic to nickel are warned that they may have a reaction to the device.
Was it approved by the FDA?
Essure was originally manufactured by Conceptus Inc. and was approved for sale on the U.S. market in 2002. Bayer HealthCare Pharmaceuticals bought Conceptus Inc., in 2013 and continues to make and market Essure in the United States as the only safe and effective form of permanent birth control with an implant procedure that can be performed right in the doctor’s office without the use of general anesthesia.
What is the procedure?
Your physician can implant the Essure coils right in the office without anesthesia. To do this, they slide a small flexible, hollow tube called a hysteroscope through the vagina, cervix, and uterus to the opening of the fallopian tubes. The doctor then passes the small, metal Essure coils through the tube to place them into the fallopian tubes. The coils expand to fill the fallopian tubes and cause scar tissue to form to block the fallopian tubes, and prevent fertilization. You are still able to get pregnant as the scar tissue is forming, so you need to use another form of birth control for up to six months after implantation.
Can Sterilization be Reversed?
To reverse Essure sterilization, the coils must be removed from the body and the fallopian tubes repaired. To do this, a surgeon makes small incisions above the pubic hairline to reach the fallopian tubes. They will cut each tube enough to remove each coil along with the surrounding scar tissue. Your surgeon will then reconnect each fallopian tube to the uterus. This procedure may weaken the uterine wall making it more likely to rupture should you get pregnant.
What are the Side Effects?
According to Essure, the original post-marketing study, the manufacturer reports that patients experienced the following side effects for a few days after the procedure-
|What are Essure’s Side Efects?||Percentage|
|Mild to moderate pain||12.9%|
|Nausea and vomiting||10.8%|
|Pelvic pain, back discomfort, and fainting||To a Lesser Extent|
Bayer reports that other side effects may include chronic pain, device migration that could require surgical removal, and a greater chance of ectopic pregnancy if the patient does get pregnant.
Have Women Complained about Adverse Events?
Women have reported adverse events to the U.S. Food and Drug Administration since the device hit the market in 2002. In fact, more than 5,000 adverse events were reported to the Manufacturer and User Facility Device Experience database, called MAUDE for short, between 2002 and 2015. The most common adverse events reported include:
- Abdominal pain
- Heavy and prolonged periods
- Weight gain
- Incompatibility – such as with allergic reactions
- Coil migration
- Coil breakage
- Malposition of coil(s)
The FDA also reported that four women died in connection to Essure, with one woman dying from each of the following –
- Uterine perforation
- Air embolism
In 2015, the FDA conducted a panel review of Essure where they reported finding more than 20,000 complaints on social media networks from women who were experiencing serious side effects and adverse events. The agency also said they had seen a dramatic increase in the number of Essure adverse events over the two years prior. In 2016, the FDA called for a black box warning for Essure over device migration, organ perforation, and persistent pain.
Controversy Surrounding Clinical Trials
Researchers published the results of an Essure safety trial in the journal Human Reproduction in 2003 finding that in nine of the 200 women implanted with the device, the fallopian tube was perforated by the coil and the device was expelled or migrated somewhere else in the body. One in 10 women also reported painful intercourse, and one in eight reported painful periods.
A later clinical trial involved 518 women, of whom, only 449 were able to use and rely on the birth control device. Of those, at least 21 cases of fallopian tube perforation, expulsion, or migration were reported, and eight women were forced to undergo surgery to find and remove migrated coils or to be sterilized. However, the FDA had required the device maker to monitor study participants for at least five years, yet the trials only followed most women for two years or less. In fact, the FDA said that only 171 women were followed for the full five years and in a report that is heavily redacted the agency wrote that at least one of the women became pregnant, and five had to undergo hysterectomy. Study participants reported nearly 300 adverse events. However, researchers determined that Essure was a factor in only 17 cases and that pain and bleeding were rare in women with the device.
Then, in 2015, in the Journal of Minimal Invasive Gynecology, researchers published the long-term data for the trial, though the required monitoring period ended in six years prior. However, researchers only followed about 70 percent of the original participants. Data on 30 percent of the participants were not included in the long-term study, an issue that experts say occurs when patients experience problems.
Essure Black Box Warning
In 2016, the FDA required a new clinical study to be completed for Essure in an effort to determine heightened risks for patients. The government agency also ordered a label change to the device including a Black Box Warning, which is the FDA’s most severe label warning. Read more about the clinical study 18-month interim results, and the final report.
Essure Sales Restriction
In April 2018, the FDA restricted the sales of Essure to only medical facilities that agree to use a 23-page Patient-Doctor Discussion Checklist & Acceptance of Risk and Informed Decision Acknowledgement. This booklet and accompanying form are to ensure that women who are considering the device understand the risks and dangers that have been associated with Essure.
Are There Lawsuits?
Some of the women who participated in the clinical trials said the manufacturer altered or hid the women’s reports of side effects like severe pain in order to get the birth control device approved.
Now, thousands of women are turning to the legal system for help, alleging that Bayer failed to warn of the risks and dangers of Essure, failed to properly inform and train the medical community how to manage implant complications, and failed to report device migration and expulsion.
More lawsuits are expected to be filed after a California state judge ruled Bayer could be held accountable for injuries caused by its product, even though federal regulations protect many devices makers from this liability. At least 200 hundred Essure lawsuits have been filed in California alone alleging the device causes severe chronic pain, moves after being inserted, and perforates organs.
If you or someone you love has suffered injuries after receiving the Essure permanent birth control implant, call us today. We are tireless advocates for the rights of those harmed by medical devices like Essure and the manufacturers who put profits over people. We believe Bayer should be held responsible for the injuries caused by this device, and we will fight to get you the maximum compensation allowed by law.
Our firm has spent decades fighting big pharma, and we will hold them accountable for your-
- Current and future medical costs
- Chronic Pain
- Secondary surgeries
- Psychological distress
Contact us today for a free, no-obligation, fully confidential case evaluation. We will get through this together.
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