Lexington, KY Essure Lawyer
Essure is a permanent form of birth control that was made available to women in 2002. It was advertised as a non-evasive procedure in which tiny, flexible coils are inserted through the vagina and cervix and into the fallopian tubes—eliminating the need for surgery. The best part about the device was that it was supposed to be permanent unlike most forms of procedural-based birth control.
Due to the non-evasive nature of Essure, the procedure was quickly approved by the FDA and became popular across the United States. Years later, after thousands of patients experienced complications after having had the procedure, the FDA is in the process of reconsidering their approval. If you or someone you love has had this procedure and experienced complications, keep reading. It’s also a good idea to consider contacting a Lexington, KY Essure lawyer at your earliest convenience.
The Dangers of Essure
While many women experience no complications after the Essure device is inserted, many women experience painful side effects that can lead to lifelong serious conditions, a forced hysterectomy, or the forced removal of the device. There have even been a handful of deaths associated with side effects from the device.
The most common early symptoms experienced within the first year of having the Essure procedure include the following:
- Severe abdominal cramps/pain
- Severe bloating
- Back pain
- Severe cramps
- Weight fluctuations
- Vaginal discharge and infection
- Painful intercourse
- Abnormal bleeding/heavier periods
- Arm and leg pain
- Severe headaches
In response to numerous reports about these negative, painful side effects, the FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contained over 5,093 voluntary reports from women who experienced negative side effects from an Essure birth control device between the years 2002 and 2015. In these reports, over 2,000 women stated that the device migrated, broke, operated differently as expected, was improperly positioned, or was incompatible with their bodies.
The FDA held an official review panel of the device in September 2015 in response to these reports. During the review, the FDA ordered Bayer, the current manufacturer of Essure, to obtain additional information about Essure’s benefits and risks. Additionally, the FDA placed an updated boxed warning on the product’s labeling, helping women understand the risks of the device and physicians consult with patients about those risks. Additional actions are still being considered to this day, but for now, the device is still readily available on the market.
After the review, as reported by ABC News, over 20,000 complaints from women started appearing over social media. Furthermore, the FDA has seen a dramatic increase in reported adverse side effects since the panel. Many reports lead to the removal of the Essure device. Others, unfortunately, result in women having to undergo hysterectomies.
Obtaining Help from a Lexington, KY Essure Lawyer
With thousands upon thousands of complaints available to the FDA, it’s difficult to fathom why the Essure procedure is still so commonly recommended by doctors. There is evidence suggesting that the manufacturers falsified some of the information from Essure’s clinical trials. Participants in the trial are starting to come forward, stating that they reported having severe pain on multiple occasions after the device was inserted, yet that information was not found in the trial reports.
Personal injury attorneys around the U.S. are starting to accept cases from clients who have been seriously injured and had their lives negatively affected by the Essure device and procedure. It’s quite possible that the only way the FDA will take proper action is with help from our nation’s legal system. With so many women experiencing serious side effects from the device, it’s time to take action.
If you or someone you love has had their life negatively impacted by an Essure device and procedure, don’t hesitate to reach out to Todd W. Burris, Lexington, KY Essure lawyer today. Todd Burris is currently accepting all Essure cases and will do whatever he can to help you or your loved one recover. Contact our Lexington office to learn more or receive a free consultation.