DEFECTIVE MEDICAL DEVICES & PHARMACEUTICAL INJURIES
MEDICAL DEVICE & PHARMACEUTICAL INJURY
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What is Essure?
The Essure device is a small, flexible coil made from a combination of nickel, titanium, and polyethylene. A coil is inserted into each of the patient’s Fallopian tubes, which connect the ovaries to the uterus. During the days and weeks after the insertion, the coils irritate the lining of the Fallopian tube. This causes a buildup of scar tissue that blocks sperm from traveling up the tube to encounter the egg, and it also prevents eggs from traveling down the tubes to the uterus.
Like tubal litigation, Essure is generally considered permanent. Unlike tubal litigation, however, Essure does not require surgery to perform. Instead, the procedure can be done in a doctor’s office. For many patients, insertion takes only 10 to 15 minutes, and the entire visit can be accomplished within an hour. And because Essure is non-hormonal, it has been recommended to patients who reacted badly to hormonal forms of birth control such as the pill.
The manufacturer’s initial five-year clinical study of Essure estimated that it was 99.83 percent effective in preventing pregnancy-- an efficacy rate that rivals tubal litigation and is higher than many other forms of birth control. However, according to a 2015 analysis published in the New England Journal of Medicine, there has been a dearth of studies about Essure, and, of those published, there have been methodological concerns with that research. (For example, there has been an insufficient number of longitudinal studies.) And this limited research may have resulted in minimizing concerns about Essure’s possible side effects.
What if I've Been Harmed by Essure Already?
The Essure Permanent Birth Control system received FDA approval in 2002. Released by its creator, Conceptus, Inc. in the same year, Essure was heralded as a breakthrough for many patients: a form of permanent, nonsurgical birth control. Since its release, however, Essure has been the subject of numerous medical complaints, lawsuits, and increasing scrutiny by the FDA.
What are Essure Injuries?
In 2015, the FDA listed a number of “reported adverse events” related to Essure use.
The FDA noted that some patients have required surgery, including hysterectomies, in order to locate and remove the Essure coils.
The agency also noted that failure of the device, or lack of physician follow-up care, had resulted in unintended pregnancies. Some of these unintended pregnancies were “ectopic” pregnancies-- pregnancies in which the zygote implants into the wall of the Fallopian tube, rather than in the uterus.
Ectopic pregnancies can be fatal to the mother.
Use of Essure has been linked to at least 26 deaths nationwide. Three of these deaths have been confirmed to be related either to the use of the device or to the implantation procedure. Research is ongoing to determine whether the device might be linked to additional deaths, injuries or illnesses.
- Persistent or chronic pain
- Perforation of the uterus and/or fallopian tubes
- Migration of the device within the abdomen or pelvis
- Abnormal or irregular bleeding
- Allergy or hypersensitivity reactions to the components of the coils
- Autoimmune reactions (when the body’s immune system attacks its own tissues).
Allegations Against Conceptus & Bayer
Injuries caused by the Essure device have led to a number of lawsuits against Conceptus, Inc. and Bayer. The most common claims in these lawsuits allege negligent creation of the Essure device. Some include allegations that the manufacturers failed to warn the public about the risks posed by using the device, including insufficient notices in packaging and related paperwork. Claims have also been made that the manufacturers haven’t provided physicians with the requisite training to implant Essure devices.
In addition to the lawsuits, between November 2002 and May 2015, more than 5,000 patients filed Essure-related grievances with the FDA. They complained about the agency’s role in addressing adverse event reports and demanded more stringent labeling and testing of Essure. Patients have even filed petitions demanding that Essure be pulled from the market.
FDA responses to Essure Injury Reports
In September 2015, the FDA held a meeting of the OBstetrics and Gynecology Devices Panel, part of the agency’s Medical Devices Advisory Committee. The purpose of this meeting was to hear expert scientific and clinical opinions as well as patient testimony, regarding Essure use. The FDA also solicited public comments, receiving feedback from more than 2,800 individuals and businesses.
After reviewing this information, the FDA took several steps regarding Essure use.
Bayer was ordered to conduct a postmarket surveillance study, in order to gather more information about Essure’s risks and benefits.
The FDA issued a final guidance note that required a “black box” warning to be placed on Essure packaging and paper-work. The note also required a “Decision Checklist” to accompany each Essure product. The checklist was intended to better inform patients about “the devices, its use, and safety and effectiveness outcomes,” according to the FDA. The FDA reviewed a citizen petition alleging that Bayer had mislabeled Essure and that data about Essure’s safety had been changed during clinical trials. However, the FDA found that there was not sufficient evidence to support either claim.
The FDA reviewed a citizen petition alleging that Bayer had mislabeled Essure and that data about Essure safety had been changed during clinical trials.
Did Essure Harm Someone you Love?
Patients injured by Essure may be able to obtain compensation to pay for medical care, therapy, pain and suffering, lost work time and productivity and other damages. The experienced personal injury attorneys at Reich & Binstock can provide a free, confidential consultation to help you understand your options and protect your rights. Please call us today at 713-622-7271.
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