WASHINGTON — U.S. health officials on Monday placed new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant, called Essure, will remain on the market.
The Food and Drug Administration said only women who read and have the opportunity to sign a brochure about the risks of the device will be able to receive the implant made by Bayer. The checklist of risks must also be signed by the woman’s doctor.
The new requirement comes almost two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of the device’s safety.
The FDA, just another government scam to pick the pockets of the American taxpayers. This article proves it’s all about the almighty dollar and not the people’s health and well-being. What about making Bayer responsible for all the women who received the implants before the additional reading material and now are suffering from complications/ side effects and no doctor who is willing to attempt the removal related to the high risks of complications. When and how do they get relief? The FDA should be ashamed of their actions, or lack there of, in this debacle.
With the info about ~50% ovarian CA prevention from complete bilateral salpingectomy, I could see this procedure becoming more and more obsolete, even without all of the complication stuff. But it is a cash cow for outpatient offices, which makes it popular.
Hard to believe any implantable device which has been verified to puncture the uterus and migrate is still being allowed on the market. It’s not OK for any implant to destroy a uterus and deny anyone the ability to conceive. It’s not OK for any woman to have an implantable device which migrates from original site. Surgery, adhesions, pelvic pain is the pathway when this occurs. I find it unbelievable this device has not been immediately banned from the market. Sounds like a version of the Fall in shield to me…and look how long before THAT nightmare implant took to finally be banned from the market: Deaths, PID, total hysterctomies, pregnancies with offspring born with the shield implanted in the newborns shoulder….I don’t care how many gyns “sign off” a checklist for continued use of this implant. If I were the pt.,I’d run out the guns office and know I was in the wrong place with a M.D. worrying about his/her cash cow, NOT my health and well being!
Sorry, my comment above was changed from intended wording of “DALKON SHIELD” to “fall in.” So much for the notso smart phone. Tried to edit and correct the mistake, no method to accomplish this, hence my follow up comment for correction purposes here.