How little are women valued in this society, when a device that purposely causes pervasive and tissue-killing injury to the fallopian tubes -- the "coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months" -- is deemed safe and beneficial, and therefore approved by the governmental entity meant to protect us? Why do women opt for such primitive birth control methods, one step above the ancient practice of placing a rock in a camel's uterus? It blows my mind that a woman would look at this Essure device and say, "Hey, great idea!"
8
The other alternative for women for long-term sterilization was a tubal ligation, which is expensive, cannot be done by a doctor in a doctor's office and requires heavier anesthesia (adding to the cost) and tubal ligation induce scar tissue as well. That's why women would opt for it. Really, your choices were to insert a metal coil inside your Fallopian tubes to induce scarring, have a surgeon cut you open to sever and ligate your tubes, or have a surgeon remove your entire uterus and tubes (which induces other problems). No wonder some women chose the first.
3
So let me get this straight as it's a little confounding to me. Women are undergoing a dangerous medical procedure to prevent pregnancy because the alternate, safe and simple procedure of their male partner having a vasectomy isn't acceptable. Why aren't medical doctors and clinics strongly suggesting vasectomies as the best practice for permanent pregnancy prevention? Is women's health so much less important to that of men?
6
You are assuming that all women who want to prevent pregnancy are having sex with one, long-term partner. That is quite an assumption. Unrealistic, to put it mildly.
7
Because some women want to ensure their own sterility and not the sterility of their partner, even if they do have only one long-term partner. Since women are the ones who bear the brunt of pregnancy and childbirth many simply want control over their own fertility.
2
This is interesting because I've had an Essure for the last 6 plus years. With zero problems. I was recently in for an annual exam, where my OB/GYN recounted how he originally placed the Essure. He followed its placement with an ultrasound. To ensure proper installation. I remain 100% satisfied. Hypertensive meds also have a black box warning.
4
Best advice I ever heard from a doctor:
The best form of birth control for women over 35 is a vasectomy.
The best form of birth control for women over 35 is a vasectomy.
4
If -- IF -- that woman has one, long-term partner. Why do so many people commenting here assume that only the monogamous need or deserve reliable birth control?
3
A vasectomy is not birth control for a woman. It only controls it for a man. And what if he decides he wants it reversed? What if he's abusive? What if a woman simply can't convince her partner to get one? We'd balk at a man trying to coerce his partner into doing something medically she didn't want, but believe it's okay for women to do so to men? And, as the above commenter pointed out, not all women who want permanent sterilization are in long-term monogamous relationships.
1
Altho alluded to but not specifically noted in this case is a registry of patients that had Essure implanted. In America drug/device companies resist these because of expense and interference with free market and innovation principles. So if problems arise they can be recognized early AND strategies for correction quickly refined.
About 10 years ago the registries of hip prosthesis in England and Australia identified a problem of loosening and dislocation with a new type of hip (
Johnson & Johnson Pinnacle hip among others ) The registries in England & Australia finally identified the defective prosthesis but a USA registry with higher faster numbers would have sounded alarm earlier.
About 10 years ago the registries of hip prosthesis in England and Australia identified a problem of loosening and dislocation with a new type of hip (
Johnson & Johnson Pinnacle hip among others ) The registries in England & Australia finally identified the defective prosthesis but a USA registry with higher faster numbers would have sounded alarm earlier.
1
Let me throw this out there: vasectomy.
10
Agree 100%: in fact my wife and I faced that exact question. Essure would have been free from her HMO (100% paid for) but we (especially her) got freaked out by the device. Vasectomy was definitely more expensive but sometimes the simple and basic procedure works best. It was a far easier procedure than Essure ever would have been, and no issues since.
1
Vasectomy assumes that the woman in question has one long-term partner and also puts the control of fertility into the male partner's hands. It may work for some women but others would rather be assured that they themselves are sterile.
1
Our practice used to place these but when we learned that some of the data by the original company (Conceptus) was fabricated we felt strongly to stop placing them about 2 years ago. Ever since we have been working with patients to remove them when desired. Unfortunately Bayer has taken the stance that their product is flawless, we've have seen patients with unintended pregnancies and symptoms that no one can explain. They usually end up seeing a Rheumatologist or allergist who advise removal of the coils. Oddly once removed these women have relief of their symptoms.
It's easy for mainstream medical societies and pharma to claim that these vague symptoms are so common that 'all' women can have these issues at some point in their life, but that's just the typical diminishment of these women has being hysterical or hypochondriacs.
The sad part of medicine today is that we fail to listen to patients and women are heard even less.
I'm happy that today I'm removing far more of these devices laparoscopically, than I ever placed in the past.
It's easy for mainstream medical societies and pharma to claim that these vague symptoms are so common that 'all' women can have these issues at some point in their life, but that's just the typical diminishment of these women has being hysterical or hypochondriacs.
The sad part of medicine today is that we fail to listen to patients and women are heard even less.
I'm happy that today I'm removing far more of these devices laparoscopically, than I ever placed in the past.
21
Are there ever any women asked for their analysis of women's health issues, esp. reproductive ones, esp. from drug companies? Why is it that men continue to feel that the risks and benefits, ones that they never have to experience, can be determined without asking women?
TO NOTE from article:
“Doctors kept saying there was nothing wrong with me,” said Ms. Myers
YET
---- "nearly 10,000 reports of injuries and pregnancies related to the device"
Guess all the surgeons are hacks! Can't possibly be the device.
"Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.
“THESE ARE SO COMMON TO WOMEN (my caps),” said Dr. Edio Zampaglione. -----urghhhh ... the Little Woman just doesn't know what she is saying!!!!!!!!
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn.
This whole thing takes my breath away.
SHAME SHAME SHAME on Bayer and the FDA
TO NOTE from article:
“Doctors kept saying there was nothing wrong with me,” said Ms. Myers
YET
---- "nearly 10,000 reports of injuries and pregnancies related to the device"
Guess all the surgeons are hacks! Can't possibly be the device.
"Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.
“THESE ARE SO COMMON TO WOMEN (my caps),” said Dr. Edio Zampaglione. -----urghhhh ... the Little Woman just doesn't know what she is saying!!!!!!!!
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn.
This whole thing takes my breath away.
SHAME SHAME SHAME on Bayer and the FDA
14
10,000 reports of injuries means nothing without the context of how many devices were implanted, which is probably the reason Bayer isn't releasing the information. I can tell you 10,000 Americans suffer some terrible deadly disease, but if the population is all Americans that's slightly over .003% of the population, which would make the illness rare. Similarly, if only 50,000 women got the device implanted then 10,000 would be alarming - that's one in five! But if 500,000 women got the device we're talking a complication rate of 2%, which is pretty good given the pros of the surgery.
Bernie was right and is right when he says we need to not trust the pharma industry. Money seems to be their true bottom line. Same for insurance companies that are also big business. Similar to the company that made faulty air bags, these pharma companies are seriously messing with our bodies.
10
The incoming horde of Republicans want to fast track approval of medical devices and medications through the FDA, which will increase the propensity for harmful interventions for American consumers. This will of course, all be done under intense lobbying by drug and device manufacturers, which is one of the key reasons why our healthcare is more expensive than anywhere else in the world. The reason your insurance premiums are so expensive (never mind that we are still the only industrial country spending 20% to administer private insurance programs as opposed to 6% for the government run Medicare and Medicaid programs) is because the U.S. healthcare system is rife with opportunism. This is reflected in the overpricing for goods and services. Also, the Republicans now wish to eliminate the pay for performance and transparency aspects of the Accountable Care Act, which have benefited consumers. The only way Americans are going to get better healthcare is through increased pressure on industry stakeholders to provide transparent financial and product information, based on established scientific methods. Rushing to create opportunities for industry players is not the answer. And remember, using actuarial science, the companies that create the interventions calculate how many people will be harmed and the degree of harm before they bring their product to market.
13
This aspect of the combination of Trump, with his obvious disconnect about women and his mangled worship of "the art of the deal", a Republican House with Paul Ryan salivating to privatize Medicare, and a Senate that might be willing to succumb to Repunlican blandishments to revive a struggling economy leaves me sleepless most nights now...
I feel this nation is at a tipping point either toward the light (not likely w/these players) or back toward the darkness of the early robber barons, where business ruled and people (especially women) were less than nothing.
It will be a much harder climb back once we have taken on more debt to enrich the one-percent, polluted our environment and hastened climate change, and empowered the politics of the alt right which denegrates women as outliers.
I feel this nation is at a tipping point either toward the light (not likely w/these players) or back toward the darkness of the early robber barons, where business ruled and people (especially women) were less than nothing.
It will be a much harder climb back once we have taken on more debt to enrich the one-percent, polluted our environment and hastened climate change, and empowered the politics of the alt right which denegrates women as outliers.
2
Fast tracking can be good or bad. Sometimes it allows unethical drug companies to cut corners but sometimes it allows life saving treatments to reach very ill patients faster, or good preventatives to prevent epidemics. Still think we should have stricter rules about what types of drugs can be fast-tracked.
1
ARE THEY KIDDING? Inserting a metal coil made with nickel - that causes common contact dermatitis? I break out in a poison ivy type itchy rash from any jewelry that has nickel. No telling that even if seemed ok with a woman, that after months of implant the dermatitis could develop. MAYBE THAT IS WHAT IS WRONG WITH SOME OF THESE adverse effects.
18
Immediately after my second child was born, I was (of course) crying and saying how beautiful she was and how perfect her little ears were, and her little hands, etc.
Once I had proclaimed the beauty and perfection of every part of her, my doctor gently asked if I still wanted to "stick to the plan."
I did, and we were off to the OR to do a quick tubal ligation, 100% free as long as I had it the same day as my child's birth. No pain, and no more babies 18 years later. It was quick and simple. I can't imagine why any woman wouldn't choose it over these metal, implanted devices.
Once I had proclaimed the beauty and perfection of every part of her, my doctor gently asked if I still wanted to "stick to the plan."
I did, and we were off to the OR to do a quick tubal ligation, 100% free as long as I had it the same day as my child's birth. No pain, and no more babies 18 years later. It was quick and simple. I can't imagine why any woman wouldn't choose it over these metal, implanted devices.
11
How about because not every woman opts to have any children?
9
Many women live in areas where the only hospitals are Catholic hospitals. Tubal ligation right after giving birth is not an option at these hospitals. A doctor's office sterilization technique is the only option for many women.
6
?
Anyone can get a tubal. Mine just happened to be immediately after giving birth.
Are you truly unaware that anyone with fallopian tubes can have a tubal ligation?
*The reason I wasn't charged extra was precisely because I had given birth and was already on a bed, in a gown, with a doctor standing there. AND because I had proven that I was willing to have children, which exposed my insurance company to lots of liability. The cost to pay for 100% of the doctor's procedure and any extra epidural meds was much less than what my insurance company could have lost if I had kept having children and had one with special needs.
Anyone can get a tubal. Mine just happened to be immediately after giving birth.
Are you truly unaware that anyone with fallopian tubes can have a tubal ligation?
*The reason I wasn't charged extra was precisely because I had given birth and was already on a bed, in a gown, with a doctor standing there. AND because I had proven that I was willing to have children, which exposed my insurance company to lots of liability. The cost to pay for 100% of the doctor's procedure and any extra epidural meds was much less than what my insurance company could have lost if I had kept having children and had one with special needs.
5
The last thing I would want in my utureus would be a sharp metal coil designed to create inflammation. Undoubtedly invented by a man, it certainly sounds like a barbaric way to prevent pregnancy.
23
I can't believe it - fast track approval of a device that relies on an inflammatory response?! Inflammation is now suspected as a cause of many life-threatening diseases - arthritis, diabetis, heart disease, blood disease - to name only a few! And this device has been proven to travel and pierce organs in the body? And Bayer refuses to say how many of these things have been implanted?
There are other safer methods of birth control. The FDA should investigate and re-study their "fast-track approval" process to include control groups for products that can cause so much damage. And they should now demand U.S. sales numbers, or pull the product from the market. They need to get out from under the obvious control of big drug companies. (and get enough funding from govt!)
When did U.S. women become helpless guinea pigs, not worth the time and trouble of ensuring safety for approvals of medical products?
There are other safer methods of birth control. The FDA should investigate and re-study their "fast-track approval" process to include control groups for products that can cause so much damage. And they should now demand U.S. sales numbers, or pull the product from the market. They need to get out from under the obvious control of big drug companies. (and get enough funding from govt!)
When did U.S. women become helpless guinea pigs, not worth the time and trouble of ensuring safety for approvals of medical products?
25
Not to disagree at all with any of your comments, but an inference can be made from the statement that this was "the first sterilization procedure for women that could be done in a doctor's office". The device causes permanent sterility, not reversible birth control and it seems the possibility of making that result more accessible for women who desired it probably led to the unjustified haste. I say unjustified because the theory behind the device sounds literally torturous.
3
One only wishes that Bayer had tried the implant in men's vas deferens tubes. Then we'd have some evidence.
55
A useful study would follow the procedures used to implant this device and the damage that may be inflicted at the time of insertion. This sounds like a torturous medical test previously done on animals, except now they're using women as the guinea pigs. Why isn't there discussion of a recall and class-action lawsuit for damages?
14
"By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities."
From whom did the F.D.A. receive these reports? Doctors are not required to report adverse effects, are they? We don't even know how many devices were implanted, let alone how many adverse effects there really were.
There is huge financial incentive for finding a drug or device safe: but who would pay for a trial to show that a drug/device is dangerous and should be taken off the market?
As always seems to be the case, we're presented with a number of individuals who assert that they've been damaged. There seems to be no system in place to study what happens with drugs/devices after they hit the market. The original trials are paid for and done by the drug/device companies--who obviously want to find their products safe and marketable.
I deeply want this device to be safe, but in the larger picture, improvement in the ways adverse effects are monitored and reported affects the safety and health of even more people. Statinvictims.com
From whom did the F.D.A. receive these reports? Doctors are not required to report adverse effects, are they? We don't even know how many devices were implanted, let alone how many adverse effects there really were.
There is huge financial incentive for finding a drug or device safe: but who would pay for a trial to show that a drug/device is dangerous and should be taken off the market?
As always seems to be the case, we're presented with a number of individuals who assert that they've been damaged. There seems to be no system in place to study what happens with drugs/devices after they hit the market. The original trials are paid for and done by the drug/device companies--who obviously want to find their products safe and marketable.
I deeply want this device to be safe, but in the larger picture, improvement in the ways adverse effects are monitored and reported affects the safety and health of even more people. Statinvictims.com
10
Would you want it to be safe so deeply if it (they) were designed to be inserted in male reproductive organs?
Women get pregnant, but we do not do so alone. Let's block men's vas deferens with sharp, alien pieces of metal, inserted through the handiest opening, without anesthesia. Would the FDA ever approve such "treatment"?
A woman can only bear a child every 10 or 11 months, but a man can impregnate countless women each year. Control sperm.
Women get pregnant, but we do not do so alone. Let's block men's vas deferens with sharp, alien pieces of metal, inserted through the handiest opening, without anesthesia. Would the FDA ever approve such "treatment"?
A woman can only bear a child every 10 or 11 months, but a man can impregnate countless women each year. Control sperm.
7
Yes, if there were a device being marketed for males, I'd deeply want it to be safe.
But (and this is my point), under our present system, I wouldn't trust that it were safe...even if it was deemed safe.
If 10,000 negative reports have come in, my guess is that there are many multiples of that number of negative things that have occurred, including injury. What I'm saying is that I would not trust the safety of the device, because our system of reporting adverse effects is corrupted--especially by money from pharmaceutical companies and medical device manufacturers.
StatinVictims.com
But (and this is my point), under our present system, I wouldn't trust that it were safe...even if it was deemed safe.
If 10,000 negative reports have come in, my guess is that there are many multiples of that number of negative things that have occurred, including injury. What I'm saying is that I would not trust the safety of the device, because our system of reporting adverse effects is corrupted--especially by money from pharmaceutical companies and medical device manufacturers.
StatinVictims.com
1
I've been happy with mine. I did get tested to make sure that I was not allergic to nickel before the implant. The procedure was easy, required follow-up to make sure the tubes were successfully blocked. I've had no problems for almost 10 years. It is not a reversible form of birth control, and it was not marketed to me as such. I do believe it was imported and then later approved for use in the USA.
4
Me too.
Part of the problem with devices and drugs is that all we ever hear are first the praises from the companies about how wonderful and revolutionary they are and then the horror stories from the (usually) relatively few people who have serious complications.
That is IN NO WAY intended to dinimish the seriousness of those complications. But the overall nature needs to be understood. There are NO drugs or devices or procedures that are risk-free. What is important is that the potential consequences be understood.
Part of the problem with devices and drugs is that all we ever hear are first the praises from the companies about how wonderful and revolutionary they are and then the horror stories from the (usually) relatively few people who have serious complications.
That is IN NO WAY intended to dinimish the seriousness of those complications. But the overall nature needs to be understood. There are NO drugs or devices or procedures that are risk-free. What is important is that the potential consequences be understood.
3
And what if after you have the implant the nickel absorption happens that causes common contact dermatitis? It creates an awful poison ivy type itchy rash. Mine started about age 23, so it can accumulate over time, just because you first tested as no problem does not make it right. 10 years for you, but maybe the other women having all the problems relate to this.
3
Yes if it causes significant problems 1 out of 10 times, then there will be 9 for whom it worked and 1 with significant problems. Research into the failures could lead to a better device. I think a 1 in 10 failure rate is too high, since IUDs are available.
3
“Doctors kept saying there was nothing wrong with me,” said Ms. Myers.... “I knew, with every fiber of my being, there was still something there.”
i hate to say this, but doctors have heard it all before. and the more religiously convinced a patient seems that something is true, the more that they might discount those beliefs. if you want to convince doctors, you must try to speak their language, not expect them to speak your language:
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn....“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.
i hate to say this, but doctors have heard it all before. and the more religiously convinced a patient seems that something is true, the more that they might discount those beliefs. if you want to convince doctors, you must try to speak their language, not expect them to speak your language:
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn....“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.
1
Right. God forbid we should ever listen to a patient! Especially a woman! - The OBGYN manarchy is notorious for mistaking anecdotal reports for index cases; and for ignoring women's actual physiology for man-designed statistics, averages, and what are perhaps aptly named 'confidence levels'. The main goal is always, always revenue. Women have been trumped by this approach for centuries! What else is new?
20
Except the company making the device and the money its implementation is the one to provide that scientific evidence and apparently was not required to do much testing before this thing went into the bodies of women...
Don't you see there is a conflict of interest (financial, especially) in that process. Only now that there are so many anecdotal complaints...and medical ones...is the FDA stepping in to do what should have been done sooner.
Only now that it seems these women ARE speaking out and being noticed...
Maybe Bayer is just trying to head off a class action suit--and hopefully it would not go to arbitration vs into the courts if it develops...
Don't you see there is a conflict of interest (financial, especially) in that process. Only now that there are so many anecdotal complaints...and medical ones...is the FDA stepping in to do what should have been done sooner.
Only now that it seems these women ARE speaking out and being noticed...
Maybe Bayer is just trying to head off a class action suit--and hopefully it would not go to arbitration vs into the courts if it develops...
I have a feeling that I perhaps misunderstood you and believed you are a doctor that discounts woman's reported symptoms. Thus I wrote to you from off heated place.
This article reminded me of all the articles I've read about the philanthropic efforts of Warren Buffet and Bill and Melinda Gates to offer contraception to women in undeveloped countries. Sounds like a good idea, except that many of these programs involve offering contraceptive devices such as Essure to women before they've been widely tested or offered to American women. I guess it's true: beggars can't be choosers. Could it be that poor women -- most of whom are black and brown -- are the unwitting guinea pigs -- for American women?
12
I take it this is not a reversible method, so its only claimed advantage over a tubal ligation is that it's a quicker procedure. It sounds like basically, it works by injuring the patient; the contraceptive effect is a product of the body's response to the injury.
12
It is intended, like classic tubal ligation, to be permanent. Tubal ligation can be reversed in some cases. Removing Essure implants can be challenging and the proper method remains to be determined. It works by inciting an inflammatory response. It is not unique in that regard.
The other advantage is that it can be done in a doctor's office and doesn't require general anesthesia. Those seem like significantly motivating factors into why it may have been approved more quickly, it appears, than other methods.
2
I'm not sure this procedure should be done without some kind of anesthesia. It's a lot more invasive than inserting an IUD.
It doesn't sound as if Bayer has improved much since it sold Heroin cough syrup.
15
For monogamous couples, vasectomy is by far the most risk free solution. Don't wait too long, though -- as soon as the Christian Right has finished with Roe v. Wade, birth control in all forms is next on their list.
52
I wouldn't worry too much about it: Today's kids are having less sex than the preceding generations, and when they ARE getting it on, they're more likely to engage orally... hence the rise in throat cancers among young men - get your HPV shots guys!
It's MY generation - the boomers - that are oversexed and think with our groins. The kids today will go places sexually, we never thought to.
It's MY generation - the boomers - that are oversexed and think with our groins. The kids today will go places sexually, we never thought to.
2
I've actually known two guys - both divorced, thank you - who much later told me about debilitating troubles they had had immediately post vasectomy. Not a scientific sample at all. That still doesn't mean it is not a good option. Neither of them reported lasting undesirable effects.
1
I know some ostriches too.
All IUDs need to be pushed out starting with stopping all external funding especially from government/insurance. The risk of Uterine Cancer is clear, unambiguous. IUDs are nothing more than a practice of self-mutilation. Women do what you want but pick up the tab 100% please.
Separately, the FDA under the Obama administration has gotten spoilt rotten. The only approval they seek is from pharmas and their lobbies. Clean this agency from top to bottom!
Separately, the FDA under the Obama administration has gotten spoilt rotten. The only approval they seek is from pharmas and their lobbies. Clean this agency from top to bottom!
5
Essure is not an IUD (intrauterine device). The Essure is inserted in the Fallopian tubes, so the scar tissue prevents eggs from being fertilized.
4
@Raindrop
Technically true but besides the point and splitting hairs. Fallopian tubes are also called Uterine tubes. Granted the two are not the same in form of function, but both are devices that involve insertion into the uterus area (IUD, get?), and both come with serious risk-factors, up to and including Uterine Cancer.
Technically true but besides the point and splitting hairs. Fallopian tubes are also called Uterine tubes. Granted the two are not the same in form of function, but both are devices that involve insertion into the uterus area (IUD, get?), and both come with serious risk-factors, up to and including Uterine Cancer.
1
Metal shows on x-ray. She also suffered from incompetent medical care.
21
A piece of nickel would also show up on ultrasound but it may have been too small, or the studies were not done. Either way, they ignored the patient's pain-- or else the hysterectomy was done because of her pain. Not enough information provided to make a conclusion that incompetence or not listening were involved.
2
Nickel will cause autoimmune disease. The "allergy" to nickel is a T cell response. This device was deliberately made to create an inflammatory response to cause fallopian scarring. However killer T cells kill cells and as long as the nickel is there the t cells will continue to to kill the cells around it. That is why the perforations are occurring. The tissue is losing its integrity because of cell deaths.
17
Round and round and round we go, even though we all know the answer -- chastity.
Do you truly think most women who use Essure are unmarried/unpartnered? Or are you suggesting that married women should be chaste (and by this I assume you mean "not have sex") if they don't want children. You don't suggest birth control pills (or any other type of BC), so are you saying that my two options are (a) pregnant or (b) no sex?
4
Chastity? Not very practical! Unless you are asexual.
5
Hahahahaha
7
Goiiod mecicine is time consuming and expensive as what is done gets more complicated. Quick and simple and certain. Reality untowards happen. How do you regulate them, when is too many too much? Who will continue to protect the public from preditory medicine, if the entire process: science: mfg. testing, application(doctors), monitoring, enforcement are controlled / paid by the same interest.
We can't get life saving drugs fast tracked, and generics are slower than molasses to market, yet we can fast track Essure? I wish we had the investigative reporters of yesteryear who would look into why this is. Follow the money, journalists, and you'll find the corruption.
32
The money has been followed and followed and followed. The results have been published. It is not very complicated; regulatory agencies are strapped for money and then their budgets are reduced. As the citizens of the US just demonstrated, they are the body that is not interested in government that regulates rationally.
We are going to have to depend on state attorneys general in the more enlightened states for after the fact enforcement of egregious malfeasance in the foreseeable future. A lot of bad products will be introduced and/or stay on the market. Ironically, some of the injured will have voted for that outcome.
We are going to have to depend on state attorneys general in the more enlightened states for after the fact enforcement of egregious malfeasance in the foreseeable future. A lot of bad products will be introduced and/or stay on the market. Ironically, some of the injured will have voted for that outcome.
2
Carol is correct. There is no secret. The investigative journalism has been done. Now it is up to the government to change the way FDA is run: supply adequate funds for evaluation of drugs, require adverse events to be reported to a national database, remove the internal conflicts of interest that cause situations like that with Bayer and Essure. The problem is a lack of political will and the well-funded lobbying of the pharmaceutical industry. Medicare Part D is a case in point: a sop to the industry and a boondoggle for the patients. We should have a look at the way it is done in Europe.
2
Medicare Part D can save lives. The donut hole has to go as many patients have to discontinue their medications for the rest if the year when they reach that cut-off.
Of course, not eating for the rest of the year is an option.
Of course, not eating for the rest of the year is an option.
1
Americans, Congress and the Obama and Trump Administrations: Fix FDA medical and dental device regulations to put patient safety first. They are practically medieval. Medical and dental devices that are not biocompatible - without patient prescreening for tolerance vs. toxicity which varies by gene type - fuel inflammation and costly, debilitating chronic diseases. Sign the MEDDSURGE petition: For Medical and Dental Device Safety Urgent Reform.
2
What is the use of placing a black label on the box of the device, since the final customer, the women that might experience the pain, will never get to see the box? It is only the physician who will insert the device in their uterus who will get to see the warning, and s/he probably already knows about the nefarious side effects. The device should be taken out of the market immediately, as there are other safer alternatives available, but once again, the FDA is dragging its feet...
32
You can find "prescribing information" and "professional package inserts" on line, usually as PDFs. Read them, but check the dates. Do the math yourself, as statistics can be made to say anything the statistician wants.
1
Nickel is a well known allergen and is a component of essure. I don't understand why the FDA would think that this was safe to approve.
We keep reading how dangerous inflammation is in our bodies--leading to autoimmune disorders and heart disease. From what I know as a lay person, essure seems too risky on many levels to prescribe and insert in women.
We keep reading how dangerous inflammation is in our bodies--leading to autoimmune disorders and heart disease. From what I know as a lay person, essure seems too risky on many levels to prescribe and insert in women.
24
There needs to be a required mandatory disclosure of the nickel content. I and many other women I know have such severe nickel allergies that we can't wear any type of jewelry that contains nickel. When I got a partial plate recently, my dentist had the company who manufactures the plates send me a certification of all the metals involved. I cannot begin to imagine the serious reaction that a coil like the one shown could cause in an allergic woman.
PS: Some stainless steel includes nickel so never allow any type of metal insert when you don't recieve a complete list of the elements in the alloy.k
PS: Some stainless steel includes nickel so never allow any type of metal insert when you don't recieve a complete list of the elements in the alloy.k
1
I am a 70 year old woman who had three children. My husband then had a vasectomy at 30 years of age. No physical problems following (he is still in excellent health at 70) and no sexual performance problems ever. Those three children were sons. Married and with children. All have had vasectomies. No following physical problems and no sexual performance problems following either. When are enough men going to stop thinking they will lose their "manhood" if they have a vasectomy and more take on the responsibility of contraception? This should not be something women exclusively need to be concerned about; it is so much more fraught for women than for men. (PS: I don't identify as a "feminist"; however I am not reluctant to say that women have throughout much of our western society been given the raw end of the deal.)
86
Bravo to all of the men in your family who did this. Vasectomies are great.
14
Vasectomies might be good for some people, but because they are performed on men, that leaves women relying on the man. For women in non-monogamous relationships, who have just started a relationship, or whose partners are not interested, other options must be explored. Women are, after all, the ones who get pregnant and may feel a personal concern to be certain.
6
Yes. Barrier methods. Following your line of thinking (which is rambling off topic but I felt must be addressed), you are correct that the woman is the one saddled with not getting pregnant in any relationship she is in, whether in mono/poly/other situations. But if her primary partner has had a vasectomy (YEA!) and she has another partner, there is more than just pregnancy to worry about. STIs for instance. So whether her primary partner has a vasectomy or she is sterilized, bring chlamydia into the picture and it's all for naught.
The article mentions only one reason for this "sterilization" device being used instead of more traditional ways of obtaining the same result: it can be inserted in a doctor's office thus reducing the cost as well as travel time for the user. I assume also since it is a Bayer product that it is in use elsewhere in the world although the article does not mention global experience. Many contraceptive products have real-world trials on poor women without access to health care so this device would seem to meet that need.
It is always distressing to read about for-profit products that prey on poor women and their families. The need to limit family size to escape poverty can lead to desperate measures including offering ones own body to be used in a trial of a "fast track device". While one wishes that manufacturers would be more ethical in developing drugs and devices, that is a wish unlikely to be fulfilled when there is so much profit in this market segment.
It is always distressing to read about for-profit products that prey on poor women and their families. The need to limit family size to escape poverty can lead to desperate measures including offering ones own body to be used in a trial of a "fast track device". While one wishes that manufacturers would be more ethical in developing drugs and devices, that is a wish unlikely to be fulfilled when there is so much profit in this market segment.
7
At this point, the Food and Drug Administration is a weak sister in all the most important ways - protecting the Public Health. And this is after eight years of a Democratic administration. Public Citizen tells us not to try any new medical device or pharmaceutical until it has been on the market for seven years. Otherwise, let the buyer beware.
23
Would things really improve after seven years?
Your doctors are not required to report adverse effects to the F.D.A.
The original drug trials were paid for by the pharmaceutical company, which then paid the F.D.A. to review the drug for approval.
So who keeps track of what happens after drugs are on the market--either regarding benefit or adverse effects? This is not a rhetorical question.
The new issue of JAMA is still debating whether statins (drugs that have been around for a very long time) are of benefit for primary prevention. As far as adverse effects, the old trials, paid for by Big Pharma (JUPITER for example) are still being referred to.
No, you aren't safe after a drug has been out for seven years.
StatinVictims.com
Your doctors are not required to report adverse effects to the F.D.A.
The original drug trials were paid for by the pharmaceutical company, which then paid the F.D.A. to review the drug for approval.
So who keeps track of what happens after drugs are on the market--either regarding benefit or adverse effects? This is not a rhetorical question.
The new issue of JAMA is still debating whether statins (drugs that have been around for a very long time) are of benefit for primary prevention. As far as adverse effects, the old trials, paid for by Big Pharma (JUPITER for example) are still being referred to.
No, you aren't safe after a drug has been out for seven years.
StatinVictims.com
10
Now that we can search studies on line, as well as consistent reports of adverse effects for drugs and devices (don't forget the rest of the world), we do not have to depend on FDA. Some of us had access to Medline in the early days and know which journals are not beholden to industry.
1
Grainne- Don't tell me, tell our doctors!
1. Benefit of drug "proven" through trial paid for by pharmaceutical company.
Submitted by pharma company to F.D.A.--with payment for the F.D.A.'s work made by the pharma company.
2. Adverse effect of the drug not required to be made by anyone but the pharma company, who has every money motive not to find problems.
Does your doctor know all this?
Probably not, or not the depth of its damaging meaning.
So...don't trust FDA, don't trust your doctor. Go to Medline.
PS. What journals aren't beholden to pharm industry?
1. Benefit of drug "proven" through trial paid for by pharmaceutical company.
Submitted by pharma company to F.D.A.--with payment for the F.D.A.'s work made by the pharma company.
2. Adverse effect of the drug not required to be made by anyone but the pharma company, who has every money motive not to find problems.
Does your doctor know all this?
Probably not, or not the depth of its damaging meaning.
So...don't trust FDA, don't trust your doctor. Go to Medline.
PS. What journals aren't beholden to pharm industry?
1
Stop playing games with women's health!
If this thing was tested just briefly, as mentioned in the article, why was it released for use so quickly?
When the reports of problems come in, don't blame those who report problems with the device, and look at the device!
It sounds like that issue with the power morcellator devices which ended up spreading cancer in women, leading to deaths, even as drug manufacturers denied the correlation.
Stop playing games with women's heath!
http://blogs.wsj.com/briefly/2016/03/18/5-things-to-know-about-morcellat...
If this thing was tested just briefly, as mentioned in the article, why was it released for use so quickly?
When the reports of problems come in, don't blame those who report problems with the device, and look at the device!
It sounds like that issue with the power morcellator devices which ended up spreading cancer in women, leading to deaths, even as drug manufacturers denied the correlation.
Stop playing games with women's heath!
http://blogs.wsj.com/briefly/2016/03/18/5-things-to-know-about-morcellat...
22
Is this device made by Bayer, as in Bayer's Aspirin?? If so, I will never buy anything manufactured by Bayer again. Having said that, a woman would be a fool to implant something in her body that could, "puncture her fallopian tubes and uterus, and travel into her abdomen and pelvic cavity and could cause her persistent pain." If you know this, just don't do it. There are other contraceptive options that are so much safer.
27
Another reason not to buy Bayer aspirin is that you are paying an enormous (in percentage terms) amount for a brand name and no other difference from the generics.
2
As an obgyn resident I have participated in several laparoscopic essure removals. There are so many other excellent ways to prevent pregnancy including iud, nexplanon, laparoscopic tubal and salpingectomy that are very well tolerated. I will likely not be offering essure in practice. That being said, there is insufficient evidence to attribute many of these symptoms to the device and there are many more common causes of back and pelvic pain such as endometriosis, fibroids, GI problems and of course obesity and poor physical fitness. We counsel patients who wish to have their essure removed that there is no guarantee the procedure will improve their symptoms.
48
I say let's de-fund the FDA. Who needs any watchdogs over corporations?? In Trump land we'll just eliminate all regulations-- reduce government involvement so that companies are unhindered in their ability to create new products and make money. We can trust corporations to do the right thing!
29
FDA medical and dental device regulations are so outdated, and so biased toward device approval vs. patient safety, they are practically medieval. We can't all get the same blood type transfusion, or eat peanut butter. Yet FDA approves devices based on averages and bell curves, let those with weaker genetic methylation paths to clear heavy metals and toxins be damned.
Want to know why autoimmune problems are so common to women? We don't pay attention to inflammatory triggers. We put them in dental fillings (mercury is 50% of dental amalgam and off-gases with heat and abrasion), medical devices (Essure, Mesh and more), etc. Why no labels and warnings like for drugs and OTCs? Why no pretesting recommended for tolerance vs. toxicity, when the FDA recommmends a patch test before hair color?
The FDA device unit and dental products unit is rife with regulatory failure, inertia and capture. It essentially works for industry - not for patient safety. This is a failure of Congress, every Administration since JFK who first proposed regulating medical devices, and and the media, for missing the big picture and drinking the Kool-Aid of its advertising sponsors and patent-holding professional organizations like the ADA.
Want to know why autoimmune problems are so common to women? We don't pay attention to inflammatory triggers. We put them in dental fillings (mercury is 50% of dental amalgam and off-gases with heat and abrasion), medical devices (Essure, Mesh and more), etc. Why no labels and warnings like for drugs and OTCs? Why no pretesting recommended for tolerance vs. toxicity, when the FDA recommmends a patch test before hair color?
The FDA device unit and dental products unit is rife with regulatory failure, inertia and capture. It essentially works for industry - not for patient safety. This is a failure of Congress, every Administration since JFK who first proposed regulating medical devices, and and the media, for missing the big picture and drinking the Kool-Aid of its advertising sponsors and patent-holding professional organizations like the ADA.
9
Do you have any scientific proof linking the off-gassing of mercury in dental fillings to autoimmune diseases? This sounds like a conspiracy theory to me-right up there with vaccines causing autism. I think it is wrong to sow such information without evidence.
5
Regarding the symptoms:' “These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.' That should put him on the DJT short list for Surgeon General.
The design - on the face of it - looks as if it were meant to imbed itself into something. Of course, I can't evaluate that, but this does seem like one very odd way to sterilize a woman, which I didn't think was that complicated a surgical procedure, but more complicated than a vasectomy.
The idea of implanting something permanently which is definitely going to be an intentional irritant over 3 months, seems likely to be able to elicit a permanent inflammatory response. I would be very concerned that this inflammation might trigger other responses.
The design - on the face of it - looks as if it were meant to imbed itself into something. Of course, I can't evaluate that, but this does seem like one very odd way to sterilize a woman, which I didn't think was that complicated a surgical procedure, but more complicated than a vasectomy.
The idea of implanting something permanently which is definitely going to be an intentional irritant over 3 months, seems likely to be able to elicit a permanent inflammatory response. I would be very concerned that this inflammation might trigger other responses.
65
Look at the design! Why doesn't it have a soft "stopper" at each end? This is ridiculous. NO MAN would allow something similar to be implanted in his colliculus seminalis or wherever such a device would be designed to be implanted.
WOMEN -- Stop allowing the pharmaceutical industry to own your anatomy! There are other (better, kinder, gentler) ways to prevent pregnancy.
And a big note to the pharmaceutical industry: Stop killing our planet's precious women with your insane and dangerous devices. There should be a zero fatality rate from any device or drug designed to prevent pregnancy.
This is yet another example of the subjugation of women for profit.
WOMEN -- Stop allowing the pharmaceutical industry to own your anatomy! There are other (better, kinder, gentler) ways to prevent pregnancy.
And a big note to the pharmaceutical industry: Stop killing our planet's precious women with your insane and dangerous devices. There should be a zero fatality rate from any device or drug designed to prevent pregnancy.
This is yet another example of the subjugation of women for profit.
75
No woman who willingly does this to herself is subjugated. Foolish and naive perhaps..
The thing is, there are plenty of ways to have sex that do not involve the risk of pregnancy. All one needs to do is be adventurous and try new things. I got past menopause without using contraception and didn't have kids and I'm a nitwit. If I can do it, almost any woman can.. All you gotta do is be daring and OWN your sexuality and body. It's easier than society would have you think.
The thing is, there are plenty of ways to have sex that do not involve the risk of pregnancy. All one needs to do is be adventurous and try new things. I got past menopause without using contraception and didn't have kids and I'm a nitwit. If I can do it, almost any woman can.. All you gotta do is be daring and OWN your sexuality and body. It's easier than society would have you think.
1
No such thing as zero fatality in any aspect of medicine at all. All we can do is weigh benefits risks and alternatives of medical interventions.
So sad to think that women have to resort to such drastic, invasive sterilization when it is so easy for a man to get a vasectomy
78
But you are assuming a monogamous relationship during a woman's pre-menopausal years. That is not the reality for many women.
2
The new labeling is a weak attempt by the FDA to appease the tens of thousands of women harmed. A black box warning and a checklist that most likely wont get filled out is not enough to educate a patient on the dangers of this device. I fear the only person who will see that black box warning will be the person cleaning out the trash can in the procedure room.
24
Many doctors don't know how to remove the device?? Wow! Women beware!!
49
In fairness, it's intended to be permanent. If a gynecologist didn't know how to remove an IUD, that would certainly be a problem, since those are temporary and need to be replaced. But Essure is permanent sterilization. It's not supposed to need to come out in the vast majority of cases - hence the common lack of knowledge and experience in removal of the device.
2
I received an Essure implant in May of 2013 and developed an autoimmune disorder that September. I haven't had any problems with the device itself, but the timing is suspicious, as far as I'm concerned. Even though I couldn't be treated successfully for this rare, but treatable, disease, I'd bring up Essure and suddenly go from being a normal patient to a crazy one: correlation vs. causation, and all that, and I'm not a doctor. But it's my body and I can think logically and do research. And if one has a disease with no apparent cause, over the years one will look for a cause. Especially if one happens to have a Master's in Library and Information Science. I'm sure the amount of literature on Essure is going to increase now, and no need too soon, since women telling their own stories aren't taken seriously.
67
Nickel is a very common allergen. The immune system activated are T cells. Get the device out as soon as you can. From an MLIS with physics and clinical research background.
17
A very small number of fatalities? Whats the number?
61
This sounds pretty scary. 1 in 10 failure rate? Complications, including serious ones, up to and including death? Best method of removal -- unknown?? Fast tracked into use -- but now a study is underway? And the developer Bayer blames poor medical practice for problems with the device??
Whew!! This device does not sound ready for prime time.
Whew!! This device does not sound ready for prime time.
107
This device damn near killed me. I would never recommend anyone get this device.
37
I am very glad my doc gently talked me out of this a few years back. I ended up going with traditional tubal ligation and have been quite happy with the results (she even went in through an old surgical scar). My doc didn't like that Essure had only been on the market a small amount of time (not long enough to know long term problems) and was worried about the fact that it is partly made of metal (patients having trouble with vaginal mesh (?) implants).
42