NASHVILLE, Tenn. - Two years ago, NewsChannel 5 Investigates first raised questions about a relatively new form of birth control called Essure.
Our investigation found women suffering from excrutiating pain and other problems they blamed on the device. Complaints across the country have grown in numbers. Now, there's word of a legal challenge that may allow these women to finally go after the manufacturer in court.
The thousands of women who have complained about the serious health problems they've suffered because of Essure birth control have had no legal recourse. But, that could soon change.
Five lawsuits recently filed against Bayer Healthcare, the manufacturer of Essure, claim the birth control should never have been approved by the federal government.
The permanent birth control device is made up of a pair of coils that are inserted into a woman's fallopian tubes. The resulting scar tissue is supposed to prevent conception.
But the lawsuits claim the original manufacturer of Essure, Conceptus, committed fraud during the clinical trials of the device. There are allegations that Conceptus under reported adverse events and was involved in "deceptive marketing."
Kimberly Lira was one of the women 15 years ago involved in those clinical trials, until that is, she said she complained about extreme side effects.
"They told me that it was just a really easy procedure and just a few minutes was all it took, " Lira recalled.
She went on to say, "I reported the excessive pain from day three all the way until they dropped me from the study."
These new lawsuits could change the game for thousands of women across the country.
When Essure was approved by the FDA back in 2002, it was granted what's known as premarket approval, which protects the manufacturer from any sort of product liability and prevents consumers from suing the company.
These lawsuits claim that Essure's manufacturer violated the conditions of its premarket approval and lawyers argue that the company should no longer be shielded from lawsuits.
If the judge allows these cases to move forward, it could eventually clear the way for other women who claim they've been harmed by Essure to sue.
Two years ago, when we first reported on health problems associated with Essure, Eva Noss described the intense and chronic pain she'd been living with since she'd had the device implanted.
"It just felt like somebody was just stabbing you in your lower abdomen," Noss stated. "My cramps from my menstrual cycle literally went from mild to extreme."
More and more women are telling similar stories. In the last two years, the number of adverse events reported to the FDA or serious complications or injuries attributed to Essure has grown substantially. There were 850 in 2013 and now 5,093 as of May 31st of this year.
Two years ago, after our first report, the FDA reviewed the complaints and studies on Essure and took no further action calling the device both safe and effective.
Bayer said in a statement Monday: "Patient safety is our top priority, and we have great sympathy for anyone who is experiencing pain, regardless of the cause."
The company said it is aware of the problems some women have had with Essure.
As far as the status of the lawsuits, the case is being heard by a federal judge in Pennsylvania. We could hear what the judge decides as early as the end of this month.
BAYER'S COMPLETE STATEMENT:
At Bayer, our mission is to create medicines and devices that help people. Patient safety is our top priority, and we have great sympathy for anyone who is experiencing pain, regardless of the cause. We have also read the stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002.
As the manufacturer of this product, we have a responsibility to share the facts about Essure with you and your viewers:
• We take all adverse events seriously. Most of the side effects that have been reported recently about Essure are known and included in the Essure Instructions for Use information. This was confirmed by the FDA which found that “[a]lthough there is evidence of complications, as there are with all medical devices, overall results from [a five-year] study did not demonstrate any new safety problems or an increased incidence of problems already known.” None of the information the FDA reviewed from the manufacturer safety database, the 5 year study, and available clinical literature established a causal connection between Essure and certain reported problems such as extreme fatigue, depression and weight gain. For further information on FDA’s position on Essure, please click on:
( http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm) 1
• Essure has more than a decade of research and development in addition to a decade of real world experience. Based on the total units sold since launch, approximately 750,000 women worldwide have had Essure placed. Essure has been shown to be highly effective in preventing pregnancy (99.83% based on five-year clinical study data) and the safety profile has been documented through numerous clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that “hysteroscopic tubal occlusion for sterilization [Essure] has high efficacy and low procedure-related risk….”
• More than 600,000 tubal ligation procedures are performed in the United States each year. We stand by the benefit-risk profile of Essure as an important option available to women who want non-surgical permanent contraception.
• Bayer conducts hands on training with physicians across the United States and provides ongoing support in the appropriate use of Essure. In addition, trained Bayer medical specialists conduct continuous outreach to healthcare professionals in order to learn more about how Essure is used in their practice and to answer their questions.No form of contraception should be considered appropriate for every woman. No form of birth control is without risk or 100 percent effective. As with any medicine or device, it is important that women discuss the benefits and risks of any birth control option with their physicians.
- Women Report Painful Side Effects From Birth Control
- Manufacturer, FDA Warn Women Of Possible Essure Risks