FDA Investigates Risks of Permanent Birth Control Device

How safe is Essure permanent birth control? According to a recent article from WebMD News, the U.S. Food and Drug Administration (FDA) announced its plans to “hold a public meeting to discuss the safety of the contraceptive device Essure.” The FDA has concerns that this form of birth control might pose serious safety risks to patients.

What is Essure? According to WebMD, it is “a small metal coil placed via catheter into the fallopian tubes,” and it is currently “the only permanent birth control device approved for use in the United States.” The FDA initially approved the device back in 2002, but in the last thirteen years the agency has received “thousands of complaints from women who use the device.” Some complaints have been of a non-life-threatening nature, including the following symptoms:

  • Abdominal pain
  • Menstrual irregularities
  • Headaches
  • Fatigue
  • Weight fluctuations

While the FDA has concerns about these complaints, it is particularly alarmed by complaints indicating that the Essure device migrated, became malpositioned, or broke. The FDA highlighted that “there have also been a number of deaths of women potentially linked to Essure,” as well as “five reports of fetal death after women became pregnant while using the contraceptive device.” More than 400 women have reported instances of migration.

Since the potentially dangerous device went on the market, the FDA has undertaken two “postmarket surveillance data” studies of the birth control method. According to a report from NBC New York, federal regulators have concerns about inconsistencies in the clinical trials that initially resulted in FDA approval. Along with data about patient injuries from the product since 2002, the FDA will take a closer look at the methods used in the clinical trials. The agency’s Obstetrics and Gynecology Devices Panel will meet in September “to discuss the findings and help decide on next steps with regard to the device.”

Facts AboutEssure Permanent Birth Control

What else do you need to know about Essure? Even if you do not experience any complications from this medical device, it is important to understand that it is only intended for women who are absolutely certain about ending their fertility. Although it is a short, nonsurgical procedure, it cannot be undone.

What are the risks of using Essure? The following statistics indicate the likelihood of certain complications associated with use of the device:

  • More than 12 percent of women reported experiencing mild to moderate pain after receiving the Essure inserts.
  • Nearly 30 percent of women with the device reported cramping.
  • About 7 percent of patients reported vaginal bleeding or pelvic discomfort.
  • More than 10 percent of women experienced nausea and/or vomiting.
  • Long-term risks include chronic pelvic pain and migration of the device through the fallopian tubes, which can require corrective surgery.

While no news has yet to come out about a medical device recall, it is important to know the above facts about Essure. If you have been injured by this product you should contact an experienced defective medical device attorney to determine your rights.

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