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Essure Micro-Insert Coil Device: A Detailed Explanation

ESSURE MICRO-INSERT COIL DEVICE
A DETAILED EXPLANATION

Essure is designed to cause permanent blockage of the fallopian tubes. This blockage is not immediate but happens slowly over time. During the Essure procedure, the doctor inserts a single Essure micro-insert device into the opening of each fallopian tube.

Each Essure device is a pair of coils. The outer coil expands and anchors the coil into the fallopian tube. The inner coil contains fibers, which promote scar tissue formation. The formation of scar tissue within the tube is what causes the tube to heal with scar tissue and become permanently blocked.

The larger, wider outer coil is an expanding coil made from a nickel titanium alloy, otherwise known as nitinol. The purpose of the outer coil is to expand after insertion and to firmly anchor the device into the fallopian tube.

The smaller inner coil is made of stainless steel. Wrapped around this inner coil are polyethelene (PET) fibers. The PET fibers acts as an irritant and cause the ingrowth of scar tissue, which will firmly anchor the entire system in place and cause permanent blockage of the fallopian tube.

The outer coil is designed to both remain in position inside the fallopian tube and hold the inner coil in place. The inner coil is designed to hold the PET fibers in place and the PET fibers are intended to promote scar tissue formation. Once the scar tissue has formed then the fallopian tube will be permanently blocked.

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Essure outer coil

Nickel titanium alloy

The outer Essure coil is composed of nitinol, which is a 50:50 mixture of the metal nickel and titanium. Nitinol has a long history of use in the medical field for various applications. Nitinol is commonly used in orthodontics (braces), vascular stents, and orthopedic implants.

The alloy is thought to be ideal because of its unique temperature changing properties. The alloy can be designed to hold a predesigned shape when warmed and a different predesigned shape when at room temperature.

When a nitinol stent is placed inside the human body, the temperature change causes the alloy to reconfigure, or transform, to its designed coil like state. In orthodontic use the increase temperature inside the mouth causes the metal wires to contract and apply tension to the teeth. When nitinol is used in vascular stents the increased body temperature causes the stents to expand to a pre-designed shape to keep the blood vessels open. In the Essure micro-insert system the nitinol causes the outer coil to expand and conform to the shape of the fallopian tube.

Although nitinol is commonly used in medical applications there are three main limitations of this alloy: stress fatigue (breaks easily), allergenicity (allergy causing) and carcinogenicity (cancer causing).

Stress fatigue: Nitinol is commonly used in applications that require flexibility and motion. Stress fatigue happens with most metals when used in demanding situations. Nitinol is felt to be superior to most other metals but nitinol metal fractures and fatigue have been observed in medical uses where the metal is being exposed to the most amount of stress.

Allergenicity: Nickel is a component of nitinol and nickel is a known allergenic substance in humans. Nickel is well known to cause contact dermatitis when exposed to the skin. The primary manifestations of nickel allergy are skin rash, hypersensitivity, swelling in the area of contact, and pain.

Initially allergy or hypersensitivity to nickel was a contraindication for patients to have Essure; however, in 2011 the FDA removed the nickel contraindication based on data submitted by Conceptus.

Although nickel is a well-known allergen it was determined the highest amount of nickel released into the blood stream from the Essure coils was 0.14 micrograms per day. By comparison, the average daily consumption of nickel is estimated to be around 300 micrograms per day. It was determined the chance of having a nickel related adverse event (nickel allergy) from Essure was approximately 1 in every 10,000 procedures.

Carcinogenicity: Nickel is also carcinogenic in lab animals. Although reasonably suspected of being carcinogenic in humans, nickel has never been conclusively proven to cause cancer in humans.

Conceptus did perform animal studies prior to FDA approval and there was no observed increased risk of cancer in laboratory animals.

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Essure inner coil

Stainless steel

The inner Essure coil is composed of stainless steel, which is an alloy of steel and chromium. Stainless steel is often chosen for applications were durability is required. The primary appeal of stainless steel is the metal is strong, durable, and will not rust with exposure to moisture. Stainless steel is commonly seen in surgical instruments and orthopedic implants.


Polyethylene (PET) fibers

Polyethylene terephthalate (PET) fibers are a plastic material and a member of the polyester family. The PET fibers are wrapped around the inner stainless steel coil. The inner coil keeps the fibers in place and the PET fibers form a matrix for scar tissue ingrowth.

Although very controversial, polyethylene terephthalate is speculated to possibly be an endocrine disrupter under certain conditions. An endocrine disrupter can cause abnormalities with a person’s endocrine system (ovaries/testes, thyroid, pancreas, adrenals, etc.).

Meet Dr. Monteith

As a surgeon my reputation & integrity are extremely important to me. I’ve been providing new choices & new beginnings since 2008. I’ve had the distinct privilege of being the first surgeon in the world to report successful pregnancy within the peer reviewed medical literature after reversal of transcervical hysteroscopic tubal sterilization. Permanent is not forever at my practice! HAVE QUESTIONS?

What Our Patients Are Saying

“We had our surgery on 3/18/15 and on 02/02/16 our 7 pound 11 oz baby girl was born! I’m 34 years old and had tubal ligation done via clamps 8 years prior so this surgery really does work! 8 years later I had the reversal and 9 years later we were blessed with our little girl! So many doctors tried to talk us out of it-wanted us to do IVF to get our money-however praise God we went with this because it does WORK! Dr M is amazing and his staff! The area is beautiful where his office is, and if you do this procedure it will be the best money you ever spend!”

– Charlee-Belle M., Surgery

“From the very first phone call, the staff at A Personal Choice has been amazing! They have answered our numerous questions, concerns and have been amazing. They never give you false hope, but give you the complete story. I am so happy that we chose Dr. Monteith and his staff to make our dreams a reality. Can’t wait to start trying to have a baby. I would and have recommended Dr. Monteith to ANYONE wanting a tubal ligation or vasectomy reversal. Thank you all so much for giving us this chance!”

– Angela W., Essure Reversal

“Excellent service overall! Each stage of the process was carefully explained in great detail: how the procedure works, what to expect during the procedure, what to expect after, possible side effects. Dr. Monteith himself is very knowledgeable and experienced and quite personable too. He has a great sense of humor and uses it generously to put patients at ease. I highly recommend him and his staff to anyone considering either a vasectomy or a vasectomy reversal.”

Chris B., Vasectomy Reversal

“The perfect little angel that I’m holding in my arms right now is the best testament to what Dr. Monteith and his staff do for people. We could not be happier with our decision to use Dr. Monteith. His staff are just amazing. Our entire experience was just a dream! Thank you, from the bottom of our hearts, thank you!”

Jamie B., Reversal of Cut & Tied Tubes

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Your questions about reversal surgery will be answered directly and promptly by Dr. Monteith. Please read our most frequently asked questions before submitting your questions. Dr. Monteith will not respond to general medical questions or if you are a patient of another doctor and are contacting him because your doctor is unavailable.* If you have been a patient at our reversal center and have specific questions about your medical care you should contact the reversal staff directly at (919) 977-5050.

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