ATLANTA, Sept. 21, 2015 (GLOBE NEWSWIRE) — Atlanta fertility specialist and robotic surgeon Dr. Edward Dourron of Servy Massey Fertility Institute performs Essure removal using minimally invasive robotic surgery, not hysterectomy, and will present his experiences with this method to the U.S. Food and Drug Administration (FDA).
On September 24, the FDA is reviewing the mounting complaints about Essure, which has been under attack by healthcare advocates because of the risks from side effects. An allergic reaction to nickel, one of the side effects, has resulted in a backlash of women anxious to have Essure, the only non-surgical method of sterilization for women, removed from their bodies. Removal should end any Essure side effects the woman experiences.
“Rather than removing the entire uterus, we can safely take out the Essure device, along with a portion of the fallopian tube, thus preserving the uterus and preventing unnecessary hysterectomies,” says Dourron, who has been an American Association of Gynecologic Laparoscopists designee to the Center of Excellence in Minimally Invasive Gynecology since 2012.
“Robotic surgery, with its precision in small operating areas, is the best way a surgeon can remove all three tiny parts of the Essure device, which is essential,” said Dourron. “And I will tell the FDA that many women – and physicians – are unaware of this better option.”
Essure, a three-piece device with metal springs produced by Bayer, is placed inside each of a woman’s two fallopian tubes, causing scar tissue to form. This prevents sperm from reaching a woman’s ovaries to fertilize an egg or prevents a fertilized embryo from traveling to the womb to implant for a pregnancy.
Approximately 750,000 women have selected the Essure form of sterilization. Thousands of women have had hysterectomies that remove their uterus and fallopian tubes in order to remove the Essure device. While hysterectomy is the proper treatment for some women, particularly if other complicating factors exist, many women can have Essure removed from their fallopian tubes by a microsurgeon, without the need for a hysterectomy.
As with any medical procedure, the insertion of Essure in a woman’s fallopian tubes has a risk of complications. A debate about the device’s side effects, such as pain, fatigue, weight gain and in some cases, allergic reactions.
The FDA meeting September 24 will review reports of the device causing health problems beyond what was included in the product’s labeling and approval studies.
Meanwhile, whatever the pros and cons of the device, many women want it removed. However, they may be afraid to do so because they think it can only be accomplished by a hysterectomy that removes the entire uterus (womb).
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