Written by: Dr. Jonathan Weinstein
Over the last 14 years in private practice there have been many occasions where patients have been referred to me for pelvic pain. There are a number of reasons a women may suffer this problem but today I would like to focus on one particular one that is rarely spoken about, but is seriously under reported by physicians and medical device companies.
For some Gynecologists the use of a medical stapler is common place. A series of surgical staples or clips are used to remove an ovary, tube or to free up a uterus during hysterectomy. In one push of a button the blood supply is cut off to the anatomical part being removed and a staple line is left in the patient and on the side where the pathology has been removed.
General Surgeons use medical clips to remove the gallbladder and they remain in the patient for the rest of their lives. Staples, clips and other implanted devices are usually described as ‘inert’ – deficient in active properties; especially, lacking a usual or anticipated chemical or biological action. They are generally made of polyester fiber, nickel-titanium and/or stainless steel alloy.
There have been numerous times over the years I have found myself removing these inert foreign bodies from patients having pain. I personally have never used staples, as there are many other tools at a surgeon’s disposable that can get the same result.
So why do I bring this topic up? A recent patient reminded of the potential problems created by ‘inert’ surgical devices and I thought back to the different patients I have removed staples, clips and most recently the Essure device. Each of these patients had something in common, their complaints of pain, which were met by deaf ears from their physician or remarks like ‘it’s all in your head’ or ‘it must be a bladder or intestine problem.’
More than 600,000 women have Essure for birth control and most have no problems with the device but it is becoming apparent that it is not all “good times” for some people who have Essure. According to the Essure website there are no long term complications from placement of the Essure implants.
One of my new patients, Jen had Essure placed 2/2011, she had her right tube and ovary removed years earlier. She had pain on her left side every day after the procedure was performed. She was told it was a Urology problem but the Urologist ruled that out, then her OB finally agreed to remove it. She underwent laparoscopy and hysteroscopy 10/2011 and was told the single Essure was removed by pulling it out from inside the uterus. She still had constant pain, had been through two ultrasounds showing the Essure was still in place but was reassured by yet another physician in her doctor’s group that only a small piece remained and it was not the source of the pain.
Two years and three months after initial placement I received an email through our website asking if I had any insight in to her persistent pain. I called her that night. First we established you cannot just pull out an Essure, as it works by becoming part of your fallopian tube and uterus over a 3 month period. The only way to safely remove it is by hysterectomy. At the time of her daVinci hysterectomy I found her Essure just sitting next to her tube, not in her tube at all. Her two years of pain was gone as soon as she woke up.
Now some skeptics would say this is an unusual case, but I have heard this story before. An Essure Physician Spokesperson told me a story four years ago about a patient having a hysterectomy at a local DFW hospital for Essure related pain, unfortunately for this patient the doctor doing the surgery used the wrong type of electrocautery which led to permanent femoral nerve damage. When I look up Essure complications on the internet in turns out there are many vocal women with similar complaints.
Now I am not here to pick on Essure, I list it on my website as a procedure I am trained to perform, it is really not that complicated. I have learned to counsel my patients that persistent postoperative pain although rare, may happen and that the only treatment is hysterectomy. Honestly, if men would just step up to the plate and get a Vasectomy I would not even need to offer Essure. Right now Essure, for most women is the cheapest method of permanent birth control, as it is an in-office procedure.
This takes me back to surgical clips and staples. One patient I took care of about seven years ago complained of the sudden onset of severe right lower abdominal pain and nothing was found on ultrasound so I performed a laparoscopy. The inside of her belly was pristine except for a single surgical clip that had fallen off her gallbladder surgical site. I picked it up removed it and was out of the OR in 20 minutes. She woke immediately with complete pain relief. Another patient had persistent pain for 12 months after the removal of an ovary and her gynecologist told her it was not related to her surgery. I went in and picked out every staple that had been used to remove her ovary and she woke up with complete pain relief.
‘Inert’ does not mean you will have no pain if the device is pushing on a nerve ending. It definitely does not mean your body may not outright reject its presence, because every person is unique. Hey, people are allergic to Benadryl, the allergy medicine, go figure?
The point of this story:
- Do not let anyone dismiss your complaints of pain when you have a foreign body placed in you.
- Ask your doctor not to put staples and clips inside of you during gynecology surgery or for that matter any surgery, if possible.
- Bayer Healthcare, the maker of Aspirin and the recent purchaser of Conceptus, the Essure distributor, update your website as you are misleading the public. Essure can cause pain. The part of the patient brochure that says “the inserts are soft and flexible and are designed to bend and conform to the Fallopian tubes” is true, but you are downplaying the fact that the insertion device is rigid enough to poke a hole through a patient’s uterus. In addition, there needs be mention of the potential long term complications of Essure placement, as they do exist.
- In general, complications of surgery are gravely under-reported. I believe it is partly because physicians are not allowed to be human. There is a tremendous fear of litigation, which is greatly justified in this country. Each patient I perform a procedure on has to read and sign a detailed document (Informed Written Consent) outlining all the risks and potential complications of their surgery. It is the biggest joke in medicine, if a complication listed on the consent actually occurs the patient can still sue. What is the point?
I hope someone out there finds this information helpful, if not, at least I feel better talking about it.
Jonathan Weinstein, MD, FACOG