Erin Brockovich takes stand against Bayer birth control
After extensive testing, the Food and Drug Administration said Essure was safe and put it in a class that exempts manufacturers — in this case, Bayer — from lawsuits.
Now, environmental activist Erin Brockovich [pictured right] is taking on the company — and the law — on behalf of women who say they are suffering….
FDA records show 698 women have filed complaints about Essure in just the past five years….
Bayer… sent a statement that said, in part, “Essure… has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness.”
But with thousands of women complaining, Brockovich said the company needs to do more. She said so many of those women contacted her that she began a campaign against Essure.
“Hear these women. If necessary, take the product off the market. Take a look at it and make sure it is safe before you put it back out there,” Brockovich said.
She is also pushing Congress to repeal the law that gives Essure and other medical devices special protection, making them immune from lawsuits….
The FDA does additional testing on these products before they can be sold — and in exchange for those delays, companies get the lawsuit exemption.
The FDA declined to comment on Essure, citing the government shutdown.
~ Paul Van Osdol, WTAE-ABC4 Pittsburgh, October 16
See video at link.
Jill Stanek is a nurse turned speaker, columnist and blogger, a national figure in the effort to protect both preborn and postborn innocent human life.
It seems to me that unsafe contraceptive drugs and devices are the real war on women. They rob us of the natural function of our bodies and our God given gift of fertility. Who designs these things? Men? Here is one more class action lawsuit commercial for television.
Oops, my mistake. I forgot about the lawsuit exemption aka no right for redress. I wonder how much money Bayer made off of this device.
Looks like, best I can tell, that this protection from lawsuits came from a supreme court case decided last year - http://healthimpactnews.com/2013/supreme-court-rules-drug-companies-exempt-from-lawsuits/
Alito wrote the 5-4 decision, supported by Thomas, Roberts, Scalia, and Kennedy.
http://www.scotusblog.com/case-files/cases/mutual-pharmaceutical-co-v-bartlett/
Not a 100% sure though – anyone else able to find where the exemption came from?
My girlfriend has this. Shes only 29 and married (10 years) After 2 kids she was positive she didnt want anymore so this was done in the doctors office a few years ago. She hasnt had any problems with it but now Im curious as to what problems its causing.
She said the doctor gave her some valium and performed the procedure right there in his office. She said it was painless and came home the same day.
Ok Ive just gone to the site to see what problems it has caused. sheesh Im glad I found out as I was considering it for myself.
For many essure works fine. There are two general types of problems.
First: nickel allergy.
Second: the things do not implant and scar over as intended.
Long story short, this is a different way to do tubal ligation (now becoming tubal litigation). A small coil of metal is placed in the fallopian tube. It gets stuck. Scar tissue grows around it, and it thus becomes incorporated into the body. The scar ideally causes a total blockage of the fallopian tube. From that point, no swimmers can reach the egg, so pregnancy can only happen by divine intervention.
This was offered to us. Since I am suspicious of medical care generally, I looked it up. I pulled up original-data studies. They taught me science, reading, logic, biology, and journalism in high school, so this is not over my head. College helped out even more. People, you can investigate these things on your own. This will keep you safe from the docs who follow the party line. Our OB made this seem innocuous and assuredly safe.
[Warning: local pro-choice commenter Reality believes I cannot read and understand medical articles, so take all of this with a grain of salt, and we will all have to wait Reality’s official pronouncement.]
Here is how this goes. First, allergy testing for nickel is NOT done; rather, the little spring thing is stuck way inside you. If you have nickel allergy, you have a bothersome reaction, and you tell the doc. The doc is totally puzzled because the drug rep did not mention this. There is no dispute regarding whether the essure spring thing includes nickel. It is acknowledged. It is a vital component of the essure spring thingie.
The doc has no way of discovering this, since there is NOW only 1 document listed in pubmed when you search for “essure nickel allergy,” and that reports post-market surveillance data, which is near worthless since docs are not reporting negative reactions, and are not nickel allergy testing.
Nickel allergy is the most common metal allergy. You can self-test for only $25. IOW, not a big deal to add this testing to the essure work-up.
If the nickel doe snot get ya, the spring might.
At an outpt visit, the essure thing is inserted to a certain place in the fallopian tube. hopefully it gets stuck there and causes complete scarring. This is documented to happen maybe 85% of the time.
Before you get the green light to have marital relations, the doc has to test whether each of the two essures have blocked their fallopian tubes. This is tested, 3 months after insertion, with an “HSG test.” In this test, a dye is sent into your special parts, and then after some time for this dye to spread wherever it can, they x-ray to see whether it has gone beyond where the essure ought to be in each fallopian tube.
This is when they discover: all went well; or the essure is there but did not block 100%; or the essure gizmo is not there.
Where did it go?
The overall rates of these things not being there are fair. maybe 5-15%. Numbers are NOT reported in the research literature. Yet. The guess/assumption is that it fell out, passed out your private parts, and who knows got in your panties and went through the washing machine, or probably down the commode.
There are cases where the essure spring thing has perforated the fallopian tube, and been stuck there, or has passed thru fallop tube and gotten just into wherever in your body. It can perforate a blood vessel, your intestines, anything.
Of, say, 1,000 women/2,000 essures, how many migrate elsewhere in the body from where they ought to be? No data.
We declined essure. Why? The doc could not tell me, in plain English, how often the essure disappeared in body versus went out the commode, or where, if it went elsewhere in the body, where it went.
There is no protocol for searching for this gizmo if, at the 3 month HSG test, it is not in place. They do not automatically start a search party to see if it is right up by your intestine.
If I am wrong, someone please correct me. Note some official protocol to follow when the essure springthing is not where it ought to be.
If either is not there, then they repeat the process. You re-test after another 3 months.
So, success rates are reported basically for the portion achieving blockage after the first insertion (ideal) plus the portion with success on the second, if needed.
Some women on the web report that HSG testing is unpleasant, and that they were not appropriately warned. This is not great patient care, but in the long run is not serious, medically.
Some portion of women have pains after insertion, even with proper placement/scarring/blockage.
The medical establishment right now is ignoring this; they are just histrionic females to this big business. Docs have no data to go on if 1 of 50 patients falls into this category.
On top of all of this, Bayer negotiated with FDA to be immune from lawsuits from essure.
Go figure that one out.
In college, they taught me “population biology,” which is theebb and flow of population sizes, varying fecundity in response to environment, and so on. This includes disease impact on populations.
Here is a principal: unless you conduct a systematic, thorough search for adverse events, with a system for detecting most or nearly all, you cannot possibly have decent data.
In the last couple of decades, states have developed very good birth defect “surveillance” programs. So, now, we know how many kids are born with the notable birth defects. Before that, we had no idea.
Bad outcomes can be reported by docs. Do they? maybe, maybe not.
There are women reporting their experiences where they had abdominal pain, and docs did not put two and two together for a long time, finally identifying the essure as the problem after months of various work-ups.
Erin Brokovich is taking on a great task. Ultimately, in my opinion, nickel sensitivity testing ought to be done on candidates. Bayer has used the low incidence nickel reaction data to move in the other direction.
Studies should be conducted to answer: if the essure is not exactly in place, where did it go? Somehow, if one disappears, the body should be x-rayed or something to make sure it is not floating around, or lodged somewhere. this is not standard protocol currently. The data from that should be reported so we all know where all of the essures end up. How many end up right where they should be? How many are confirmed to no longer be in the body? How many end up perforating fallop tube, and how many migrate beyond fallop tube?
If you or a loved-one is considering this process, search the web for official info, and also the many women’s anecdotes on various discussion sites about problems. decide for yourself whether the bad cases are so few you won’t worry. Decide whether these are women mis-atttributing UTI or something else to essure, or whether you think the women are simply histrionic.
you have plenty of alternatives. You can have a tubal ligation, instead of tubal litigation.
You can discover natural family planning: if your cycles are fairly normal, you can do what married people do for up to a third of the month with no additional “protection” other than dependence on a fairly regular fertility cycle. For the rest of the month, you can abstain, or figure out some other plan for avoiding pregnancy when you are not intending to get pregnant. On the flip side, learning NFP helps you figure out the two days of the cycle when you are most fertile.
Plenty out there to learn, once you figure out that, generally, the OB docs get much of their info from the drug companies, and are very trusting of the drug companies, but at times should be more suspicious and critical, in a scholarly way.
I don’t know if she’s pro-choice or not, but I feel better knowing Brockovich is looking into this situation. She has name-recognition and that can only help. It’s barbaric what the medical profession does to women. And they don’t tell you, from PP’s pre-teen indoctrination to your ob/gyn’s sales pitch: what might cost a few bucks to do now will cost THOUSANDS to repair later.
[Warning: local pro-choice commenter Reality believes I cannot read and understand medical articles, so take all of this with a grain of salt, and we will all have to wait Reality’s official pronouncement.] – that’s an inaccurate statement TLD. I asked if you had actually read the supposed ABC link articles, because the alternative was that you knowingly misrepresented them because you asserted they supported your claim when they didn’t.
I wonder… all the guys out there… would any of you be eager or even willing to have tiny metal coils shoved into your testicles or your penis to render you infertile? How many men would be willing to intentionally damage a healthy organ in their body with metal coils? Hmm??
Well I’ve had a vasectomy Jen. No issues with that.
But if coils wrapped around the tube taking sperm from the testicles or some similar installation was available and meant reversals were more achievable (not that I want one) I don’t see a problem.
Don’t some men get inflatable devices inserted due to erectile disfunction? I believe some men get a false testicle if they lose one because they feel less manly or something.
“that’s an inaccurate statement TLD. I asked if you had actually read the supposed ABC link articles, because the alternative was that you knowingly misrepresented them because you asserted they supported your claim when they didn’t.”
-Yes, I have read each of them. Start listing any of those, one by one, that you believe do not support the ABC hypothesis. I can break it down for you. I don’t make things up. That is the main difference between me and most other liberals: I am concerned with truth and accuracy, not with a Marxist utopian dream that allows the ends to justify any dishonest means.
ABC is taboo, and being accurate about Essure is taboo.
I can’t find what percentage of patients are estimated to have complications from Essure. Does anyone have the numbers? All procedures have risks, I believe it’s around 1% serious complications for vasectomies and less than 20% minor complications (like chronic minor pain) for vasectomies. Are the numbers for Essure worse than that?
Are people being warned, like they should with every procedure, about possible complications? Is Bayer claiming there are no complications at all? There’s more to medical liability than “I had an adverse advent, now I am going to sue”. People have complications from all kinds of things all the time, the question is if Bayer is actually liable or not.
Edit: I found this report that states the complication rate at 2.7% for all complications. http://www.ncbi.nlm.nih.gov/pubmed/22360159. I can’t read the pubmed articles because I don’t have an account, just the abstracts. I don’t think this is an unusual complication rate for procedures like this. Actually I believe tubal ligations are worse in regards to complications. Of course this is one study, it could be a fluke, does anyone have a different study?
TLD, you provided a list of studies which you claimed supported the alleged ABC link.
While they may have been about potential contributing factors for breast cancer, almost none of them specifically included abortion as a causal or correlative factor. One that did address the alleged link stated in its conclusion that no link could be identified.
None of them support the ABC hypothesis.
The topic of ABC is not taboo, it has been repeatedly addressed. tested and studied and found to be unsupportable.
“TLD, you provided a list of studies which you claimed supported the alleged ABC link. While they may have been about potential contributing factors for breast cancer, almost none of them specifically included abortion as a causal or correlative factor. One that did address the alleged link stated in its conclusion that no link could be identified. None of them support the ABC hypothesis. The topic of ABC is not taboo, it has been repeatedly addressed. tested and studied and found to be unsupportable.”
First of all, this doesn’t make sense. In several of those genuine studies, abortion was included as one of several potential predictors of subsequent breast cancer. Mathematically, abortion shows up as one of the predictors.
But because abortion was not the lead potential predictor of the study, its relation to subsequent breast cancer can be ignored? That is ridiculous.
Second of all, it is a logical flaw to declare that, because one study does not have abortion as its centrally investigated risk factor, that the ABC theory is debunked. I posted many studies since the NCI 2001 report that show ABC.
Third of all: my challenge was declined.
I was expecting that. Marxist-driven liberals are so cult-driven that they have a hard time following common sense, and spotting when they have crossed the line into the irrational.
Challenge TLD? What challenge? Are you referring to where you said Start listing any of those, one by one, that you believe do not support the ABC hypothesis? Because if you are, you must have failed to note my response of None of them support the ABC hypothesis.
Do you remember the conclusions I cited from a couple of them?
CONCLUSION:
“The study suggests that non vegetarian diet is the important risk factor for Breast Cancer and the risk of Breast Cancer is more in educated women as compared with the illiterate women.”
CONCLUSION:
“Among this predominantly premenopausal population, neither induced nor spontaneous abortion was associated with the incidence of breast cancer.”
^ that is quite a naďve reading of those studies. Shameful.
Don’t be too hard on yourself TLD. I’m sure you’ll do better next time :-)
In the interim, might I suggest you take a bit of a gander at something like this –
http://en.wikipedia.org/wiki/Correlation_does_not_imply_causation
TLD, I think the lesson to be learned here is that one cannot reason with the unreasonable. I am impressed with you for trying, though.
I found it mildly amusing that when this first hit the news, I mentioned it at a local mothers’ group. As soon as I said “nickel,” every woman over the age of 30 automatically reached for her earlobes. We all remember how horrible earrings could be if you bought the cheap ones; sometimes it felt like your earlobes were going to rot and fall off. And then the question was asked, whose bright idea was it to take nickel, of all things, and bury it inside a woman’s body? Sheesh.