Questionable Medical Records in Essure Clinical Trial
A recent television report on 41 Action News in Kansas City highlighted the problems of a woman who had participated in a clinical trial for a birth control device called Essure 15 years ago.
Essure is a tiny flexible coil inserted into the fallopian tube to prevent pregnancy. Theoretically, the presence of the device creates scar tissue which blocks sperm from getting through and is an effective non-surgical alternative to tubal ligation.
The problem is there can be painful side effects to the procedure that may have been covered up during the clinical trial. According to Kimberly Lira, she reported extreme pain to the nurses during the trial, but when she requested her medical records all these years later, the word “extreme” was crossed out and many other details were altered or inaccurate.
Bayer, who purchased the maker of Essure in 2013, claims the device is a safe option for women who desire permanent non-surgical contraception. But the Food and Drug Administration (FDA) has opened an investigation into allegations of falsifying medical records, failing to report adverse events, and deceiving the public regarding the device’s safety and effectiveness.
If you have participated in a clinical trial for a medical device or drug, you have a right to request your medical records and hold the manufacturer of the product responsible if you have suffered injuries or damages due to wrongdoing during the trial. It’s not too late, even if the study ended many years ago. Contact Wendt Law Firm P.C., today for a free consultation with our Kansas City product liability lawyers. We will only receive a fee in the event of a successful resolution of your case.