Breaking News: FDA Experts to Review Safety of Essure Birth Control Implant
Read full article here.
The North Carolina Center for Reproductive medicine (NCCRM) is proud to offer a safe solution for women who are suffering from Essure complications. We have heard countless stories from women who are dealing with Essure side effects, ranging from severe headaches and abdominal pain to colon perforation. Our experienced medical team can relieve your discomfort with a safe Essure Removal.
What is Essure?
Essure is the only permanent birth control for women that does not require a skin incision. The Essure is similar to the traditional IUD in that the implantation procedure does not require anesthesia nor does the device contain or release hormones into the patient. Essure implantation is an in-office procedure and more cost effective than tubal ligation.
The Essure device consists of three components:
- An inner plastic fiber
- A flexible stainless steel inner coil.
- An outer nickel titanium alloy coil.
The procedure consists of implanting one of the spiral coils in each of the fallopian tubes. Over a 3 month period, tissue forms around the coils creating a barrier. That barrier prevents sperm from reaching the egg which prevents conception.
Since the FDA approved Essure in 2002, the success rate of preventing pregnancies rests at 99.83%. However, some women have complained of severe complications from Essure.
The FDA states that some women have experienced painful health complications after Essure implantation. One of the side-affects, noted on the Essure labeling, is pain. But in a study, conducted by the FDA from 2002 to 2013, women also noted experiencing hemorrhage, headaches, menstrual irregularities, extreme fatigue, depression, and weight gain. Other cases noted a device malfunction, either breakage or the device was not positioned properly. The FDA also suggested that because the outer coil is made from nickel-titanium, some women may have a (nickel) allergy to the device.
The agency acknowledges there is evidence of complications from Essure, but it still considers the device a safe option for permanent birth control. However, if you are experiencing pain or other complications, it is important that you are evaluated by your doctor for the cause of discomfort. If that discomfort is due to your Essure device, there is no medical team more experienced than NCCRM.
UPDATE: 9/23/15 – Federal medical experts will take a closer look at a host of problems reported with the birth control implant called Essure, including chronic pain, bleeding, headaches and allergic reactions.
The Food and Drug Administration on Monday posted a 90-page review of Essure online, ahead of a Thursday meeting where experts will re-examine the safety and effectiveness of the implant.
Read full article here.
A Safe Solution: Essure Removal at NCCRM
Dr. Sameh Toma is a microsurgeon who is highly experienced in safely removing the Essure device. While the Essure insertion is done vaginally and without anesthesia, microsurgery is required to remove it. When the Essure device is inserted into the fallopian tube, a barrier wall of tissue is formed to block sperm from reaching the egg. Within 3 months the device is embedded into the walls of the fallopian tubes. This microsurgery is done in order to safely remove all three components of the device and any coil fragments.
For women who still do not want to become pregnant, a tubal occlusion is done at the time the Essure device is removed. The microsurgery takes about one hour and is done under general anesthesia through a 2-4 inch bikini incision. Recovery is usually five to seven days.
Women who visit NCCRM know they are in good hands with the experienced, micro-surgical skills and techniques of Dr. Toma for a safe Essure removal and tubal occlusion.
Fee for Essure Removal:
Fee: $5000 + $300 Consult/Ultrasound (Please call 919-233-1680 ext. 180 for more information.)
If you are wanting to restore your fertility after removing the Essure coils, the fee is $7000 + $300 Consult/Ultrasound. The $7000 fee is only for the removal of the Essure coils. ** Please note, the upper limit BMI to qualify for surgery at any out patient surgery center is 35. You can find out your BMI here.
For some women, they carry excess weight around their bikini area that makes it difficult for the surgeons to access the area they need to operate. In that case, our surgeons may perform liposuction on that bikini area immediately before the Essure removal surgery. If liposuction is deemed necessary, there will be an additional $1000 additional fee in order to accomplish the Essure removal.
If I have the Essure Device removed will my symptoms go away?
While there is no guarantee that your symptoms will improve or completely dissipate, it appears that Essure removal will help the majority of women who are having Essure Device related problems.
If I have the Essure Device removed will I get pregnant?
Removal of the Essure Device will not restore your fertility since your fallopian tubes will not be attached to your uterus.
Why is it important that a microsurgeon remove the Essure Device?
Because of the method in which the Essure Device was constructed, each of its three components can be fractured (and left behind) if not meticulously performed by a microsurgeon, like Dr. Sameh Toma. Leaving behind a piece of the Essure Device may not allow improvement of symptoms.
My physician recommends that I have a hysterectomy to remove the Essure Device and improve my symptoms.
A hysterectomy may be the appropriate surgical approach, especially if there is other pathology such as fibroid tumors, polyps or ovarian cysts. However, a hysterectomy is a much more extensive surgery associated with more complications than microsurgical removal of the Essure Device. You must decide, after weighing the pros and cons of these options, what is the optimal procedure for you. Not all physicians can remove an essure device, so they might recommend hysterectomy.
I have no adverse symptoms from my Essure procedure but I am planning to undergo IVF (in vitro fertilization) in the next few months. Should the Essure Device be removed?
Yes it should be removed prior to undergoing IVF.
If you are interested in moving forward with Essure removal, please fill out these forms and submit them safely through our website. Our staff will be in touch with you after you have sent us the completed forms.
Have a question?
Call (919) 233 1680 or