Essure coil left in tube without consent

[icantcook]

TN
had the Essure procedure done in March 09. What was to be a 15 minute procedure became almost 2 hours. During this period, the doctor repeatedly attempted to insert the coil. The insertion device bent and had to be replaced with another. After several attempts, the coil was released improperly. I have xray film showing the coil hanging from the tube.

After the procedure, I was told I would experience short term spotting, and mild cramps. I had heavy bleeding and severe pain. As a result, I had surgery to remove the coils, and opted for a tubal ligation to be performed at the same time. The doctor removed only one coil, and left the other coil in the fallopian tube and performed the ligation around it.

I am concerned as I have a foreign object in my body that I did not consent to and do not know the long term consequence of having it there.

[Proserpina]

Originally Posted by icantcook

TN
had the Essure procedure done in March 09. What was to be a 15 minute procedure became almost 2 hours. During this period, the doctor repeatedly attempted to insert the coil. The insertion device bent and had to be replaced with another. After several attempts, the coil was released improperly. I have xray film showing the coil hanging from the tube.

After the procedure, I was told I would experience short term spotting, and mild cramps. I had heavy bleeding and severe pain. As a result, I had surgery to remove the coils, and opted for a tubal ligation to be performed at the same time. The doctor removed only one coil, and left the other coil in the fallopian tube and performed the ligation around it.

I am concerned as I have a foreign object in my body that I did not consent to and do not know the long term consequence of having it there.

Were the risks of the procedure explained to you? Did your informed consent mention the risk of complications?

(The Essure website actually contains information about the benefits and risks, including the less-common adverse effects)

[icantcook]

Thanks for your reply.
The Dr. did explain the risks. I was told in his experience with Essure, he had only one complication during the insertion and it was not directly related to the Essure.

I talked with the doctor and we agreed on removal of the coils, and I opted for a tubal ligation to be performed at that time. The Dr. only removed the coil that was not inserted correctly, and then proceeded to perfom the tubal, leaving the other coil in my tube, and burning the tube around the coil.

Without my consent, I now have an unnecessary metal coil in my body, which serves no purpose.

I've read the Maude FDA site, as well as Conceptus/Essure, and am aware that these coils can dislodge and migrate, and cause further complications.

[Proserpina]

Originally Posted by icantcook

Thanks for your reply.
The Dr. did explain the risks. I was told in his experience with Essure, he had only one complication during the insertion and it was not directly related to the Essure.

I talked with the doctor and we agreed on removal of the coils, and I opted for a tubal ligation to be performed at that time. The Dr. only removed the coil that was not inserted correctly, and then proceeded to perfom the tubal, leaving the other coil in my tube, and burning the tube around the coil.

Without my consent, I now have an unnecessary metal coil in my body, which serves no purpose.

I've read the Maude FDA site, as well as Conceptus/Essure, and am aware that these coils can dislodge and migrate, and cause further complications.

The problem is you will generally have to prove that the negative outcome was a result of negligence, and not simply a known complication of the procedure.

Additionally, you have to show damages. I'm going to defer to the more experienced folk here on that one - I don't know how sterilization after this complication would fit into things.

Have your records reviewed by a medical malpractice attorney - that's really the only way to tell whether you have a viable claim or not.

[lya]

If I understood the situation, the tubal ligation was to include removal of the coils (plural).

I see no medical benefit to leaving one coil, properly placed or not.

Removing the coil will require a second surgical procedure. The cost of the second surgery and associated expenses such as lost wages should be borne by the surgeon who failed to remove the coil.

The poster needs a second opinion from a physican not in the same practice/office as the surgeon who performed the tubal ligation. If the opinion is that the coil should have been removed at the time of the tubal ligation and will require removal at a later date, the poster should consult with a medmal attorney.

[icantcook]

Originally Posted by lya

If I understood the situation, the tubal ligation was to include removal of the coils (plural).

I see no medical benefit to leaving one coil, properly placed or not.

Removing the coil will require a second surgical procedure. The cost of the second surgery and associated expenses such as lost wages should be borne by the surgeon who failed to remove the coil.

The poster needs a second opinion from a physican not in the same practice/office as the surgeon who performed the tubal ligation. If the opinion is that the coil should have been removed at the time of the tubal ligation and will require removal at a later date, the poster should consult with a medmal attorney.

Thank you so much!

Yes, the surgery was to remove both coils, and perform the tubal ligation. Leaving the R coil was not necessary, since I had the tubal for sterilisation. This is why I'm confused. Why did he leave that coil in there?

another concern;
I had a rodded R femur; rod since removed. Due to pain in hip, I am to have an MRI.

[lya]

Regarding the rodded femur post rod removal: have the MRI first, then ask.

X-rays prior to removing the rod will show if healing was sufficient and rod removal was indicated.

[icantcook]

Originally Posted by lya

Regarding the rodded femur post rod removal: have the MRI first, then ask.

X-rays prior to removing the rod will show if healing was sufficient and rod removal was indicated.

Thanks again.
My concern is the metal and the MRI. I am post rod, so the only thing left is the Essure coil.

[ecmst12]

It is unlikely that the tiny coil will cause any issue with the MRI, but certainly ask the MRI department about it.

[tranquility]

As a person with little direct knowledge of medicine (with a good sense of the law and a keen interest in medical issues), but with a long reading of opinions of list members, if lya thinks you have something to look at, I'd look at it.

If I were on a jury, I'd say you were harmed.

[lya]

The statute of limitations must be protected. The poster knows that a foreign object remained after surgery to remove it and knows the risks of infection, migration, etc. presented by the implanted coil.

My advice is to seek a medmal consultation and to seek a second opinion, which may be an area with which the attorney can assist.

Re. the coil and an MRI:
I don't think there is a problem; but, as advised earlier, ask the MRI folks and do so before you show up for the MRI. That way, a CT scan or Ultrasound can be scheduled instead of wasting time and delaying other patients' needs just to be told the coil presents a problem and the MRI must be cancelled.

[icantcook]

Thanks to all who have replied;

Prior to setting my MRI appt. I will inform them of the coil and see what they advise.

[Hockey Mom]

To: ICantCook:

I had a similar experience with Essure in Sept. 2008 - severe abdominal pain within 10 days after the procedure. My procedure took 1.5 hours, not the 13 minutes as advertised, and it turns out my doctor put two coils in my left tube because the fallopian tube was larger than normal (strange choice??). Anyway, long story short, the two coils dislodged, and floated out of the tube and into my abdomen; one landed beneath my uterus, and the other by my bladder. So I ended up in the ER in the middle of the night in excruciating pain, and had to have emergency surgery the next day to remove the coils, and have a tubal ligation. So, $36,000 later for the hospital stay and surgery (luckily paid by my insurance co.), I ended up with the procedure I was trying to avoid in the first place. I think the Essure company does not disclose all the risks clearly and the procedure has not been tested, nor the doctors trained, enough. I am an attorney also, but do not do malpractice or products liability cases, so not sure if I'll pursue it.

[Proserpina]

Originally Posted by Hockey Mom

To: ICantCook:

I had a similar experience with Essure in Sept. 2008 - severe abdominal pain within 10 days after the procedure. My procedure took 1.5 hours, not the 13 minutes as advertised, and it turns out my doctor put two coils in my left tube because the fallopian tube was larger than normal (strange choice??). Anyway, long story short, the two coils dislodged, and floated out of the tube and into my abdomen; one landed beneath my uterus, and the other by my bladder. So I ended up in the ER in the middle of the night in excruciating pain, and had to have emergency surgery the next day to remove the coils, and have a tubal ligation. So, $36,000 later for the hospital stay and surgery (luckily paid by my insurance co.), I ended up with the procedure I was trying to avoid in the first place. I think the Essure company does not disclose all the risks clearly and the procedure has not been tested, nor the doctors trained, enough. I am an attorney also, but do not do malpractice or products liability cases, so not sure if I'll pursue it.

It's unlikely OP will be back - it's been almost 2 months.

(and if you want to be recognized as an attorney here you may wish to let admin know so they can verify the details )

[ecmst12]

I'm sure this OP is long gone since the thread has been inactive for 2 months. It's not the company's job to inform you of the risks, it's your doctor's job - and it's likely you WERE informed of the risks and signed paperwork to that effect.