Thursday, December 11, 2014

ESSURE: Stupid and Stupider

by Margaret Aranda, M.D.

Essure(R) Fallopian Coils are discussed in the Women's Book (,com/
Archives of the Vagina: A Journey through Time)

Special note: This is an Editorial. The terms "Stupid," "Stupider," and "Stupidest" are not directed at the patient. They are directed at Bayer(R), who simply needs to get it through their heads that their product is causing harm. (Bet they're selling as many coils possible now, especially to Third World countries, because they know their time will come...and EssureR) will be in the trash. Then there won't be any doctors who can deal with Essure removal or complications, especially in Third World Countries. Doctors, how can you be so stupid to violate a patient's body in exchange for bloody money?)

                                             STUPID AND STUPIDER

        Essure (R) fallopian tube coils were first approved in the United States by the FDA through Expedited Review on November 4, 2002. Hailed as a non-toxic method of "permanent"* birth control, women gleefully signed up to get this coil inserted via confirmation by hysteroscopy, or to undergo the usual surgical procedure, bilateral tubal ligation (BTL). * = an FDA video shows an FDA Panel female repeatedly saying that "permanent means one year." Components of the coil are shown in Illustration I.

                 Illustration 1. The Essure(R) coil by Bayer(R). The outer surface is coated with nickel*,      and there are two ends. The inner coil is filled with polyester fibers (PET) inside the coils and sits inside the Fallopian tube. The outer anchoring coils are comprised of a super-elastic retinol and stick out into the uterus. If needed, the manufacturer says that two coils can be placed in one tube, to ensure complete fibrosis and blockage of sperm.  
* = although reportedly not required, there is supposed to be a nickel allergy warning on the box.

Illustration 2. Essure Placement by Hysteroscopy, 1898.  Manufactured by Bayer AG's subsidiary, Conceptus. Essure(R) nickel coils are questionably advertised as a "nonsurgical" procedure. Let's not be stupid, or stupider to think that the coils will prevent pregnancy without complications, because now we KNOW the pregnancy rate is 23%.

Here are several definitions from different sources; I have highlighted the referrals to "insertion", "surgical" or "surgery" or "operative" or "operation":

1. Definition: 
a. Wikipedia: "the inspection of the uterine cavity by endoscopy (STUPID)with access through the cervix. It allows for the diagnosis of intrauterine pathology and serves as a method for surgical (STUPID)intervention (operative hysteroscopy)." (Stupid)

2. Is Hysteroscopy a Surgical Procedure or Not? The UK House of Commons Hansard Debates 19 Dec (pt 0003):
a.   ..."hysteroscopy without anesthetic"... to a woman "diagnosed with uterine cancer"..."contacted me because the process of diagnosis, rather than the cancer itself, caused her the most distressing and painful experience of her life" (Stupider)

b. ...Debbie said, “I was in absolute agony. (Stupider) The consultant who performed my procedure knew I was in pain but carried on regardless. (Stupider) A nurse had to push me back down on the bed as I stiffened like a board. (Stupider) She had to hold me there and had hold of my hands too as I was trying to reach down and stop the procedure. (Stupider) All I could think of was that if I made the consultant stop, I would have to come back and endure the whole thing again.(Stupider)  This procedure, without anaesthesia, is barbaric. ((STUPIDEST) It is absolute torture. (STUPIDESTIt needs to be stopped. (STUPIDEST) At the very least, the patient should be informed that it could be extremely painful and have options explained and open for her. That way, she can make an informed decision as to whether to go ahead without anaesthesia.” (STUPIDEST)

c.  "I was given no options (for anesthetic)(sic). (Stupider) I have complained to the PALS department and to be quite honest I am not happy with their reply. (STUPID) At one point she mentioned that the hospital gets more money for the procedure to be done as an  outpatient! (Stupider)  Is this what is boils down to? Money? Disgusting!" (STUPIDEST, but isn't that true?)
  d.    “the procedure was still very uncomfortable and painful. (Stupider) I have to say that I think offering a hysteroscopy without any form of anaesthetic is barbaric.” (Stupider)

e.   .."I felt so undignified…(Stupider) I have never felt such pain. (Stupider) I felt like my whole abdomen had been blown up, the pressure was so intense, then sharp prodding pains, I had tears in my eyes, the nurse did come and hold my hand. (Stupider) I just looked at the ceiling and held my breath, praying for it to be over." (Stupider)

When he’d done, the doctor asked ‘did you find that a bit painful?’. (STUPIDEST) I replied ‘no it was excruciating’, he just remarked that most women are fine with it (STUPIDEST) but perhaps I had a low pain threshold (STUPIDEST) and that if I were to need further treatment I would need a General Anaesthetic as I was sensitive. (STUPIDEST) I was quite gob smacked and in so much pain I didn’t really reply. I struggled to my car and drove home, I was in agony for days. I felt almost like I’d been violated, like a piece of meat, but thought perhaps it was just me, perhaps I was being a wuss. It wasn’t till I spoke to other ladies that I discovered it needn’t have been this way. My treatment on a whole I feel was done very wrongly, cutting corners and saving money, at my expense. 

The hysteroscopy should not have been done this way, it’s almost inhumane.” (STUPIDEST)


                                                     A Special Note from Sarah Salem- Robinson

The Morcellator device that routinely minces uterine tissue, during a hysterectomy or myomectomy, to be removed through small keyhole incisions has been dangerously peddled to women by their " trusted" GYNs as a cosmetically pleasing option. Many GYNs pushing the benefits of small scars and a shorter recovery onto women do not bother to inform women of the DEADLY 1:350 cancer spreading risks. Nor do they bother to advise women that an abdominal hysterectomy that would excise their uterus intact, would assure a very good chance of a complete cure should they encounter a hidden cancer like a deadly sarcoma. 

As a result, in the last 2 decades hundreds to thousands of unsuspecting women have unfortunately and unnecessarily horribly suffered till their death, leaving their children and family members irreversibly devastated with grief and sorrow.

As one victim of morcellation (of many with upstaged sarcoma) and also a Physician Assistant specializing in the OB/GYN profession for eleven years, I find it criminal that use of this horrid faulty oncologic device that seeds cancer has grown in popularity within the GYN community for over two decades despite the multiple medical journals explicitly siting the deadly dangers. There are currently 600,000 hysterectomies performed in the US yearly, with 40% due to fibroids. Use of the Morcellator on these women would amount to 2 women each day that would be given a death sentence. 

The oncological faulty Morcellator device was advanced into the GYN surgical field through FDA's 510K medical device quick approval. Deadly harm and suffering has already ensued; we can't turn the clock around for many women who have already paid with their lives. But what we can do, with your help is put an end this medical nightmare. We have made some strides: on April 17th the FDA discouraged use of the morcellator, Johnson and Johnson as the largest manufacturer removed the device off surgical shelves and a couple of east coast insurers have refused to pay for the procedure. But we need the support of our Congressman, Senators and President because we the public are up against powerful corporations and GYN societies which wish to continue this travesty against women. These powerful entities are siding with "profits" rather than the patient. 

Please join us on the side on best healthcare practices for women to ask for a finite ban on the Morcellator by the FDA and the revamping of their faulty 510K to assure that another medical atrocity does not recur in the future. 

That's why I signed a petition to The United States House of Representatives, The United States Senate, and President Barack Obama, which says:

"1. Ban the faulty Power Morcellator , a surgical device, that spreads a deadly hidden cancer masquerading as a common fibroid. 

2. Revise the FDA's 510K clearance process, that fast tracks approval of medical devices without clinical trials"

Will you sign the petition too? Click here to add your name:

~ ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~ ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~

Since 2013, controversy over the Essure(R) coil escalates as women were having miscarriages, migration of the coils, breakage of the coils, and some were getting pregnant. Some women complained of such adverse side effects as requiring a hysterectomy, requiring fallopian tube removal, perforation of a hole in the uterus, the colon (which carries E.Coli), and the question of deaths by Essure(R) coil needs further investigation. In October 2014, a physician committed suicide reportedly due to his placement of 3 Essure coils in a patient, who complained of pain for 2 years and had filed a medical malpractice legal case.

Essure continues to claim that these women with these kinds of complaints 
just do not exist (STUPIDEST)
and that their product is safe (STUPIDEST)

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 
HEY!!!!!! HEY!!!!!!
Two burning questions come to my mind: 

1.  "Is the earth really round, or is it flat?" (STUPIDEST)
2.   "Did we really land on the moon, or was that just a set & stage that was propped?"

WITHDRAWAL OF OPIOIDS AND PAIN MANAGEMENT WITHOUT OPIOIDS By Dr Forest Tennant   We are pleased to share information from Dr. Forest Ten...