The Federal Food and Drug Administration recently made an announcement about additional requirements it is placing on Bayer, the maker of Essure, to ensure a woman knows all the risks before using this permanent birth control.

But the FDA stopped just short of taking the product off the market, a plea thousands of women have made in the last year after they experienced devastating and sometimes life-threatening complications.Essure has been sold since 2002 and is frequently pitched as "the only nonsurgical option for permanent birth control."It consists of two nickel-titanium coils, similar to the coil you can find in a pen, inserted into the fallopian tubes, which spurs growth of scar tissue to block sperm from fertilizing an egg. Bayer estimates 750,000 women have received the device since it was put on the market.But even though the company states that is it safe for most women, thousands have come forward with their stories.In September, a group of women urged the FDA to recall the device at a public meeting on problems reported with Essure.In recent months members of Congress, including Rep. Rosa DeLauro, D-Connecticut, who said she would monitor the FDA's follow-up on Essure, as well as Rep. Michael Fitzpatrick, R-Pennsylvania, who introduced the bill the E-Free Act in November, which aims at revoking Essure's premarket approval, have joined the fight."The FDA cannot continue to drag its feet on medical device safety when women are suffering," DeLauro said after the FDA's plan was announced."It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market," Fitzpatrick said."Frankly, I'd contend that the 25,000 women harmed by Essure are the post-market study that FDA is ordering. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths."If the FDA is going to order another study, then at minimum they should take Essure off the market during that time."In addition, consumer advocate Erin Brockovich has also taken up the charge and is fighting to let these women be heard. Brockovich made a name for herself in the 1990s through her investigations as a legal clerk in uncovering that a gas and electric company was poisoning a California town's water source for decades.She created the website essureprocedure.net to allow women to share their stories and find hope."I believe that collectively we are strong voices that can create change and not only help ourselves but educate and share our stories so that we can help others find the help and comfort they need," Brockovich wrote on her website."It is a woman's right to decide for herself if she wants a certain form of birth control but when they are not told of the devastating side effects, well that isn't right."The FDA is allowing for a 60-day comment period regarding its requirements on Essure prior to the requirements taking effect.Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or by going to

http://1.usa.gov/1Yo2XHE before May 3. Identify all comments with the docket number FDA-2016-D-0435-0001 for "Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization."