How dangerous does a medical device have to be before the FDA takes action to protect the public?
The FDA acknowledges that there are serious risks with using the birth control device called Essure. Essure is a flexible mettle and polyester coil that looks like a small spring. One device is inserted into each Fallopian tube, where they cause scar tissue to form around them. The result is that the Fallopian tubes become blocked by scar tissue, preventing sperm from getting to eggs. The manufacturer, Bayer, reports that 750,000 women have used Essure.
When everything goes right, this device causes permanent infertility. When things go wrong, they go very wrong. According to the FDA, complications may include persistent pain, perforation of the uterus or Fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions. Some women have become pregnant, even with the Essure implants.
Women have been speaking out about the side effects on the Facebook group called “Essure Problems.” One woman reported requiring a hysterectomy and multiple follow-up surgeries. In a report on BuzzFeed, it was reported that women who get Essure implants are approximately 10 times more likely to need follow-up surgeries than women who get tubal ligation for permanent birth control. (Read more on BuzzFeed here: http://www.buzzfeed.com/azeenghorayshi/essure-birth-control-dangerous-side-effects)
The FDA has decided to allow this product to remain on the market, and asked for more safety trials. Meanwhile, how many women will suffer?
We believe that the FDA should pull this product from the market until additional clinical trials can be conducted. Profits should never outweigh patient safety. We are following this story closely and will report any new developments, and we are currently signing clients affected by Essure.
If you have had serious or painful side effects after the implantation of Essure birth control devices, please consider contacting the experienced attorneys at HensonFuerst for a free consultation. We are available 24/7 at 1-800-4-LAWMED, or use our online contact at www.lawmed.com.