Negative Side Effects Move the FDA Toward Reevaluation of Essure Birth Control Device.The U.S. Food and Drug Administration (“FDA”) is Reevaluating Essure. Essure is the only Nonsurgical permanent birth control device currently approved by the FDA.
How Does Essure Work?
In an office procedure, a health care professional inserts a metal spring into each fallopian tube. As scar tissue forms, the tube is blocked from releasing eggs to the uterus, preventing fertilization. At a follow-up visit, three months after the spring is inserted, an x-ray using dye is taken to ensure the tubes are completely blocked. At this point, the manufacturer asserts 99.83% effectiveness.
Complaints against Essure, marketed by Bayer, have been numerous. The FDA, while defending its testing of the device is open to listening to the volumes of complaints leveled against it and question whether they are all due to the birth control device. There can be numerous reasons why people could be experiencing many of these complaints.
According to Bayer, “Essure was reviewed through the premarket approval process for class III medical devices. Class III is the strictest type of marketing application”, as stated by Tara Diflueri, a spokesperson for Bayer. Some of the side effects that were acknowledged by the manufacturer include fainting, nausea, cramping, vaginal bleeding, vomiting, and pelvic or back pain for many days following the procedure. In rare cases, the body can expel the device. As many as 18,000 women have gone on Facebook to compare experiences, where the list of side effects is considerably larger. Here the women complain of chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression and severe bloating. One woman complained she was so bloated she refused to go out in public because she looked pregnant.
Due to the many complaints, the FDA is now reevaluating Essure and has revised the list of risks and side effects. The agency has scheduled a public advisory meeting of its Obstetrics and Gynecology Devices panel that is intended to bring together experts, physicians, patients and industry advocates to review the data and evaluate the public outcry. The committee will consider whether the manufacturer needs to amend its labeling or conduct further testing on the product. The major question will be, is the birth control device the cause of the lengthy problems associated with it, and how common are these complaints. According to Dr. Elizabeth Micks, an OB-GYN and Contraception specialist at the University of Washington Medical Center in Seattle, “Women may attribute health concerns to their method of birth control even if their birth control method cannot feasibly cause some of the complaints.” Micks also stated she would like to see more data concerning long-term complications.
In defense of its product, Bayer said Essure passed a detailed analysis by the Food and Drug Administration before they were permitted to market it. Opponent spokeswoman Amanda Dykeman’s reaction to Bayer has been “We don’t understand. If all these women are reporting the same symptoms why aren’t we being taken seriously?”
“I’m anxious to attend the hearing and demonstrate what we’ve learned about Essure, and its safety and efficacy over the years,” continued Dykeman. “If the right people are in attendance and they really listen to what we have to say, I believe they will have no choice but to take some kind of disciplinary action.”
Dykeman’s experience with the Essure has not been pleasant. Her pain and symptoms led her to request a hysterectomy. Her surgical report included chronic inflammation of the cervix, several attached blood clots and one of the springs had worked its way through the fallopian tube. While many of her symptoms have improved, Ms. Dykeman still complains of chronic fatigue, and back pain as well as some others.
According to Bayer spokeswoman Rosemary Yancosek, the company has read the personal stories from women about their experiences with Essure. “These stories, while compelling are not representative of the hundreds of thousands of women who have relied on Essure since the FDA approved it in 2002.
CONTACT PARKER WAICHMAN LLP FOR YOUR FREE CASE REVIEW
We recognize how greatly your Essure injuries have affected your life, and the experienced medical device lawyers at Parker Waichman LLP are ready to help you fight for your right to compensation. If you or your loved one had an Essure device implanted and experienced a subsequent injury, contact our Essure lawsuit law firm today by filling out our online form or by calling 1-800-YOURLAWYER (1-800-968-7529) for a free consultation.
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