Essure Injury Lawyers Warn about Long-Term Complications with the Implant
Long-awaited results on a trial monitoring women that received the Essure contraceptive implant confirmed the fears of many women and prompted demands that the FDA take the device off the market. The agency has received more than 4,000 accounts of serious complications related to the device, including severe pain, excessive bleeding and device migration. Five deaths have now been linked to Essure as well.
The Essure injury lawyers at Hardy, Wolf & Downing in Maine would like to alert women to the risks and let them know help is available if they suffer injuries from this contraceptive device.
The long-term data was published on April 24 in the Journal of Minimally Invasive Gynecology. The study involved 518 women that had opted for non-surgical sterilization using the Essure implant. Of that number, 366 or 70 percent of the test subjects were followed by the full five years required by the FDA as a part of their treatment programs.
Investigators monitoring this test group found that 15 of the women underwent required hysterectomies after the device was implanted, although investigators determined only two of these procedures could be directly associated with the device itself. More than one-third of the women suffered from unusually heavy bleeding during their menstrual cycle and five percent experienced recurrent pelvic pain. Close to one-fourth reported painful intercourse after the Essure device was implanted.
What is the Essure implant?
The Essure contraceptive implant was first introduced to the U.S. market in 2002. The FDA approved the device at that time under the condition that the manufacturer of the device, which is now Bayer, would conduct long-term studies on the product’s safety. The Essure was touted as the first non-surgical method of sterilization – a minimally invasive option to traditional surgical sterilization known as a tubal ligation.
The device consists of small coils that are placed into the Fallopian tubes to prevent fertilization. Over time, scar tissue forms around the device, blocking the Fallopian tubes and preventing pregnancy. During the period when scar tissue is forming, patients are encouraged to use an alternative type of contraception. Once the area adapts to the coils, it is considered a permanent method of sterilization.
Concerns raised, dangers underplayed
Officials from the FDA admitted to the New York Times that they were concerned about the device migrating out of the Fallopian tubes, but did not consider the Essure to be a flawed device. However, women who have reported this side effect often require additional surgery to remove the faulty device and even then, they may experience ongoing pain and other problems. Some women acknowledge that their implant did indeed work itself out of the Fallopian tubes, damaging other organs in the area.
A smaller study that looked at 269 women between the ages of 23 and 45 confirmed migration of the device could be a problem. This study found that nine of the women in this study had their implants move outside the Fallopian tubes and damage nearby organs. Like the women in the larger study, these women also complained of back and abdominal pain, as well as painful intercourse. Now, some of these women are beginning to file defective medical device lawsuits against Bayer, claiming the company did not properly warn women of the risks associated with their product.
Filing an Essure injury lawsuit
The product liability lawyers at Hardy, Wolf & Downing understand the lifetime of consequences caused by a defective medical device. We represent Maine victims that have agreed to these devices without the facts necessary to determine the product’s safety. We offer free case evaluations, and we don’t charge you any fee unless we successfully settle your case or you receive a court award. Call us today at 1-800-INJURED to learn more about your options for legal recourse following Essure complications.
- New York Times, Long Term Data on Complications Adds to Criticism of Contraceptive Implant, http://www.nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html?_r=1
- FDA, Essure Permanent Birth Control, http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ucm371014.htm
- WCPO, Essure Contraceptive Implant: Should it Stay or Should it Go? http://www.wcpo.com/news/health/healthy-living/essure-contraceptive-implant-should-it-stay-or-should-it-go
- WCPO, Essure Birth Control: Woman Dies, Report Filed with the FDA on Essure Coils, http://www.wcpo.com/news/health/healthy-living/essure-birth-control-woman-dies-report-filed-with-the-fda-on-essure-coils