Why Are Silicone Breast Implants about to Be Approved by the FDA?

[Time for change]

The US Food and Drug Administration is currently on the verge of approving two brands of silicone gel breast implants, which were taken off the market in 1992 by then FDA Commissioner David Kessler because of lack of adequate information on safety.

I am an FDA scientist who is posting this thread because I am concerned that the anti-regulatory and pro-corporate profit ideology of the Bush Administration is corrupting the traditional mission of the FDA which, since its inception in 1906 under the Administration of Theodore Roosevelt, has been to protect consumers against unsafe products.

None of the opinions expressed in this thread represent the official position of the FDA, but rather are my own personal opinions. All of the facts stated in this thread are publicly available knowledge.


A brief history of the regulation of breast implants

Silicone gel breast implants have been marketed in the United States since 1963.

In 1976, the Medical Device Amendment to the Food, Drug and Cosmetic Act gave the FDA control over the approval of breast implants and other medical devices for the first time.

In 1988, breast implants were re-classified as Class III medical devices, which meant that there was significantly more concern over their safety than was previously the case. This concern was mostly attributable to the known fact that some unknown (at the time) percent of breast implants rupture, followed by unpredictable consequences. Soon after that, the FDA announced that it would require manufacturers to present evidence of the safety of their breast implants in order to be allowed to continue to market their product.

In 1992 silicone gel breast implants were taken off the US market (pending additional safety information to be submitted by the manufacturers), though still allowed under certain specified circumstances, such as controlled clinical trials, to correct congenital defects, to replace ruptured implants, and for reconstruction following surgical removal of a cancerous breast.


Rupture rate of silicone gel breast implants

At the time that silicone gel breast implants were removed from the market in 1992, manufacturers claimed that the prevalence of breast implant rupture was about 1% or lower.

However, subsequent studies by an FDA colleague of mine, Dr. Lori Brown, using magnetic resonance imaging (MRI) to diagnose breast implant rupture in women whose implants had been in place for an average of a little over 16 years, found that the prevalence rate of rupture was at least 55% (Note: This figure applies to ruptures per implant, not per woman the rate per woman is substantially higher, since most women who use breast implants have them implanted in both breasts). In addition, a meta-analysis of 35 studies showed a rupture rate of 30% at 5 years and 70% at 17 years.


Consequences of silicone gel breast implant rupture

Consequences of silicone gel breast implant rupture include the following:
-- Migration of silicone to distant parts of the body
-- Formation of granulation tissue, with change in breast shape
-- Contracture of breast tissue
-- Chronic pain
-- Infection
-- Hematoma (formation of a pool of blood in breast tissue)
-- Repeat surgery because of the above problems

It must be noted that these problems are clinically significant and common. This is evident from another study by Dr. Brown, which documented that problems following the implantation of silicone gel breast implants were severe enough to require repeat surgery in 33% of women (average duration of implant for which surgery was required was eleven and a half years in this study).

In addition, Dr. Brown¡¦s study showed that women whose silicone migrated out of the fibrous capsule formed following the implant rupture were almost four times more likely than women whose silicone remained confined within the capsule to develop fibromyalgia. Silicone migration outside of the capsule occurred in 21% of women in her study.


Summary -- So why are silicone gel implants now about to be approved by the FDA?

In the FDA's recent approvable letters (an intermediate step towards approving products) to the manufacturers of silicone gel breast implants, one of the major stated conditions of approval was that the manufacturers conduct studies to see how long the implants last.

So, what has changed since major restrictions were placed by the FDA on the marketing of these implants in 1992, mainly because of lack of adequate information on safety relating to the rupture of these implants. I see these as the two most important changes:

1) In 1992 little was known about the prevalence rate of rupture of these implants. Manufacturers claimed this rate to be about 1%. Subsequent studies have shown rupture prevalence rates to be in the 30% to 70% range, depending on how old the implants are.

2) In 1992 the FDA Commissioner was David Kessler, best know for his courageous fight against the tobacco companies. In 2005 the FDA is under the Bush Administration, which is well known for its anti-regulatory, pro-corporate profit ideology, and lack of concern for the protection of US consumers.

Which of these two reasons do you think best explains the pending FDA approval?

[ck4829]

1. And just to one company

The corporatism is so thick that you can cut it with a knife.

[soothsayer]

2. cuz pukes love fake wimmen with big fake boobs

They hate real women.

[bmbmd]

8. I disagree-it is Democrats

who are the "Big Tit Party".

[mshasta]

25. yes we are....

... most of the girls that I know who are democrats are "D's" ...:P

[SoCalDem]

3. Probably...some men just love those big plastic boobies

and there are women who want to please their men..I say just wrap up the inserts and let the men carry them around with them..free to squish and fondle those plastic orbs whenever they like.. no female companionship necessary :)and he won't have to buy them dinner:P

[edbermac]

5. Not this man...

Any woman who gets them should have them implanted from the neck up.

[mtnsnake]

38. Not this one either. Women who aren't secure enough w/their own bodies

are just as much a turnoff as the artificial boobs themselves. Men who talk them into it are much worse.

I guess some women need to realize that men are turned on more by the real thing than by fakes, even if the real things are small. I know I don't speak for all men, but there are so many more things that attract us physically than just boobs....like legs, butts, her buddhalie, the way she walks, the sound of her voice, a sweet personality, etc, etc.

[OnionPatch]

4. Because when you get

a bunch of Republicans running the country you can just forget about any sort of consumer protections or product regulation. You're on your own.

[Time for change]

44. Isn't that the truth

It's the same situation with the way they handle worker protection, the environment, and the privitization of our elections with their secret vote counting machines.

[Greyhound]

6. There is only one answer to every question regarding why this bunch

does anything. Money & power. Lots of it. Really.

[KnaveRupe]

7. Wait till they approve...

...silicon Adam's apple implants!

[meow2u3]

60. ...or silicone penile implants

:evilgrin:

[Proud2BAmurkin]

9. Aren't women smart enough to decide?

I thought they were smart enough to research it and decide for themselves.

:shrug:

[Time for change]

10. That's an interesting question

Of course that question can be applied to any product that is currently regulated by the FDA: Foods, drugs, and medical devices.

The purpose of the FDA, as it was conceived nearly a century ago, was to protect consumers. It seems to me that there are way too many medical products out there to realistically think that people will be able to research them adequately to decide which ones are sufficiently safe. It's not a matter of whether we (i.e. people) are intelligent enough. The reality is that if there was no regulation of medical products, so that people had to decide on their own what products were safe, there would be a lot of additional suffering and death in this country because of that.

We saw evidence of that at the recent panel meeting on breast implants. Several women stepped up to testify that they hoped these implants would not be approved because they had had personal experiences with them that significantly negatively impacted their lives. Bad things had happened to them (as noted in the OP) that they were not aware of as significant possibilities at the time that they were implanted. In other words, the reality is, when any unsafe product is approved, that most people who receive the product will not be aware of things that they should know when they make the decision to use it. Of course, their physician may give the all the necessary information. Or, maybe not.

[Proud2BAmurkin]

24. Viagra has severe side effects

probably more dangerous than breat implants but at some point you have to let the person decide for themselves.

If the implants have a warning like any other drug that lists proven side effects, they should be legal.

[Time for change]

28. So, are you saying that there is no need for an FDA to disapprove anything

Or is there any drug or medical device that you believe should be disapproved?

[Jack_DeLeon]

31. I do. I think all drugs should be legal...

the whole war on drugs is a failure far worse than anything that is going on in Iraq.

How many people have died worldwide for the sake of prohibition.

IMO warnings of the various side effects should be put on all drugs, but ultimately it should be up to the individual to decide.

[Time for change]

39. I agree with you about the war on drugs

As you can see from this post of mine:
http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=132&topic_id=2098335

But that is a different matter. First, the "war on drugs" has many terribly harmful effects, including the unwarranted imprisonment of large section of our population. Second, these are recreational drugs, and people don't depend on them to treat their medical problems.

But do you really think that anyone has the time and ability to adequately assess the safety of the medical treatment that is available to them? Even medical professionals, who earn their living doing this, can barely keep up with all the relevant available information, and often fail to do so.

[Proud2BAmurkin]

51. No but drugs/items that have some risks for some people should be approved

provided the risks are clearly stated

[Time for change]

53. But then when do you think that they should NOT be approved?

Your statement seems to suggest that anything should be approved, as long as the risks are stated? Where would you draw the line, if anywhere?

[TOXICDISCOVERY]

35. Black Box Implants

Good suggestion! In 10 years Mentor and Inamed will also be the next Dow Corning filing Chapter 11 when "the NEW and improved" silicone is removed from: lungs, brain, heart and ovaries? Corporate Greed is what we have along with a "non-politically correct disease".

[nvliberal]

46. What bizarre reasoning.

Anybody who undergoes surgical mutilation for nonmedical reasons despite possible dangers is exercising "freedom of choice."

People take "libertarian" ideas to ridiculous extremes.

Never mind public safety or medical ethics.

[Time for change]

48. Yes, and it's not just a matter of "freedom of choice" either

When an unsafe product is approved, those who end up using it will generally do so under the assumption that it IS safe. They're not so much exercising their "choice" as they are a victim of inadequate information.

[Proud2BAmurkin]

52. That's the key. Provide risk information but don't BAN the product

There are thousands of drugs and items that carry risks.

[Time for change]

54. Yes, all drugs have risks. But a certain level of safety must be met.

It's the purpose of the FDA (at least it used to be) to determine that drugs and medical devices and foods meet a certain standard before approving them. If they don't meet that standard they shouldn't be approved.

The point is that if devices or drugs are approved that fail to meet a low standard for safety, people will suffer for that approval. It's all very well and good to say, "but just inform people of the risks". But the reality is that many people will not be so informed, and furthermore the very fact that the drug or device is approved leads them to believe that it meets a certain standard of safety.

The problem with the FDA in today's environment is that the influences of powerful corporations on Congress and the Presidency means that many FDA decisions today are based on that fact rather than an objective scientific evaluation of the evidence.

[Silicone survivor]

70. With no information

one cannot make a informed choice.

[Time for change]

73. I think that's a very important point

It's all very well and good to talk about allowing people to make their own informed choices (sounds like an argument that a Libertarian would make), but the fact of the matter is that once a product is approved by the FDA there is no guarantee that people will have the information they need to make an informed choice. And that's precisely why, IMO, we need an FDA to NOT approve products that are unsafe or ineffective.

But unfortunately, in today's environment, consumer protection has taken a back seat to the interests of powerful corporations. Sometimes upper managdment will reverse a recommendation made by FDA scientists who are far more familiar with the issue than are the managers who reverse the recommendation. That's the kind of thing that makes we want to find another job.

[mod mom]

11. $.

[Darth Lib]

12. Because silicone breast implants never really hurt anyone

Lawyers saw a target and went for it.

[Time for change]

16. I don't understand what you mean

What do you mean that they never really hurt anyone? See the part in the OP about ruptured implants and the problems that they cause.

[TOXICDISCOVERY]

34. Lawyer Induced Disease?

You must be joking. Do you believe that Latex Allergy is real? Then why do you not believe that one can develop sensitivity to silicone? Apparently you have no Medical background or knowledge?

[Silicone survivor]

72. Women were and ARE hurt by implants

I am one of them. to say implants never hurt anyone is untrue and mindless given the stacking reports, piling evidence, testimony,and new medical research that does show a link to certain diseases and implants. Dr. Brown's research does show a connection.
I have those issues and deal with them every day.
I was a healthy woman, got implants, they ruptured into my system, I NOW have fibromyalgia, lupus and a host of other issues. I have no history in my family for any of these things.
I believe I got sick from my implants. When I had them removed my heath got better, but I still suffer from connective tissue disease.
It may not be in ALL the medical studies ( especial NOT the "science" paid for by the chemical companies and manufacturers) yet. But I do believe the implants triggered my immune response.
I can show you MANY women hurt by these devices, and not just connective tissue issues, completely mutilated breasts as a result of the benin sounding "local complications" the manufacturers refer to as not a bit deal.

[greenbriar]

13. $$$$$$$$$$$$$$$$$$$

the hand that lines the pockets

[Time for change]

21. Yes -- when they try to decide what to put in a public health notice

they actually invite the manufactuers to the table to discuss with them what they might object to. No consumer advocates -- just the manufacturer.

[woodsprite]

14. Because Republicans support Big bOObs? n/t

[TOXICDISCOVERY]

36. Duh

And we thought all along it was a BIG penis they supported!

[Coexist]

40. No - they hate the mighty Clenis

the mighty Clenis is responsible for everything that will be wrong with this country for the next 12 decades!

[Time for change]

15. I should make it clear that my purpose in posting this has nothing to do

with what one thinks of breast implants as a medical intervention.

The issue that I'm trying to address here can apply to any medical product that the FDA regulates. There are many examples that I could have used, but this one is current.

My main point is that the FDA is a federal institution whose purpose is supposed to be consumer protection, but that purpose seems to be in the process of being marginalized by our current Administration and Congress.

[Sgent]

17. Devils advocate here...

Are these the same implants? It was my understanding that these used a different type of "gel" which would be more resistance to rupture, and it wouldn't create the same problems even if they did.

In addition, although the rupture rates you cited are quite pursuasive, I don't know anyone today who expects to not need replacement implants after 20 years or so.

That being the case, is this not a case where with proper warning (you will have to have these removed in 20 years), and warning the patient they need intermittent ultrasounds to dectect significant rupture, that it would be acceptable? This is commonly done with many back and knee surgery's.

Finally, what are the precentage of ruptures (cited above) that caused clinical problems. An old addage is you can't cure an asyntomatic patient. Even if there were microscopic ruptures (only detected on MRI vs. ultrasound), are these ruptures clinically significant?

After analyzing this, what's the real risk of having a clinically significant complication with silicon vs. saline? Is there any difference, a slight difference, or a large one?

Will women, properly informed of this difference, choose to have a silcon vs. saline implant due to the better cosmetic effect?

Now we have already decided it is ethical to perform major surgery for cosmetics -- so you already have a risk of allergic reaction and complication for any implant (saline included). Does the increased risk make it unreasonable to the point of only allowing cancer patients to recieve them?

[Time for change]

18. Those are very good questions -- I'll see what I can do

The implants that are about to be approved (silicone gel) are the same ones that I refer to in the OP. The companies claim to have come out with a better version now, but those kind of claims are frequently made. They haven't prevented evidence that shows that what they have now is better than the studies that showed the high rupture rates.

We're not talking about 20 years. I referred in the OP to a rupture rate of 55% per implant in a study where the average age of the implant was 16 years, but many were much newer than that.

Of course proper warnings have their place. But there is a limit. If one has the attitude that proper warnings can compensate for the approval of unsafe products, then we have a problem. For one thing, what might be considered a "proper warning" often somehow never makes its way to the patient. That's why we need an approval authority for medical products.

I don't believe that there is data on the percentage of ruptures that cause clinical problems. But the fact that we have a study that shows that 33% (of all patients) have clinical problems of a sufficient degree to require repeat surgery means that the proportion of women who have significant clinical problems is large.

The risk is significantly greater with silicone than saline, but I can't give you numbers on that.

I don't know how many women, if properly informed, would choose to have silicone rather than saline. My guess is, not many. But I think that what can be safely said is that many women will not be properly informed before making their decision. Remember, not all doctors (as can be said about any profession) are highly ethical.

I believe that the increased risk makes it unreasonable to approve this device. Otherwise I wouldn't have posted this thread.

[ErisFiveFingers]

32. Hmm.... doctors not warning their patients...

With the vast amount of different (regulated and unregulated) substances and treatments out there that have severe, and life threatening, side effects and complications, and patients who are uninformed, who bears the onus of responsibility for a bad reaction, a long term side effect?

It is possible for the FDA to revoke medical licenses, or perhaps find a different path to enforce consent? Informed consent is a chronic problem, of course, which is why many treatments become sources of new litigation... I don't really have a solution, I'm just wondering if there are any new ideas.

I'm sure that there's *got* to be more avenues than to ban borderline products, because informed consent is a problem..... perhaps working on both consent issues, and product issues, could be a way to go? Require, say, 36 hours of health counseling before a high-risk procedure, with a manufacturer stating a fixed level of liability, or proving that they could withstand open liability?

[Time for change]

41. Right now we have a number of policies in place to address patient safety

The FDA assesses products for safety and effectiveness before approving them.

It is standard practice (though not always adequately carried out) for physicians to adequately inform their patients of potentially harmful treatments.

Medical licensing board are supposed to discipline physicians who harm their patients unnecessarily (though they don't do a good job of this).

And as a last resort, if physicians are negligent in their treatment of a patient, and if that results in harm, the patient may have legal remedies (although Congress is rapidly trying to do away with that safeguard as well).

But even with all that, patients are often persuaded to accept treatments that are harmful to them. It's not a matter of "patient choice". It's a matter of the fact that the practice of medicine is way too complicated for patients to have to accept responsibility on their own of being informed of all matters affecting their health and safety. I'm not saying that they shouldn't try. But it is simply not possilbe for any human to keep up with it all on his/her own.

That's why we need to rely on the above measures. And that's why IMO those measures should be strengthened, not weakened, by an Administration and a Congress that is much more concerned with helping their cronies to ammass unprecedented amounts of undeserved wealth at the expense of traditional consumer safeguards.

[PaDUer]

27. Some of the implant groups

want to sue the FDA for being part of the coverup about the truth about the implants. How much has Dow and the other manufacurers paid the FDA to hush the truth up, any idea?

[Time for change]

47. I can't answer that question specifically

What I can say is that, from my experience, especially in recent years, the FDA treats powerful corporations with more favor than they do the consumers whom they are supposed to protect.

[Mend]

19. I would think any doctor who uses these implants

runs the risk of malpractice. I am a doctor and I know that even if something is approved by the FDA, that is not enough cover if possible complications, such as what you have given, are out there. In my opinion, it is medically unethical to use these implants. We doctors have to take responsibility for patients who might lack judgment to make informed decisions about elective surgery.

[Time for change]

20. I agree -- and I'll bet that

you would also agree that there are doctors out there who are quite a bit less ethical or informed than you are, and who would therefore not give their patients as much information about this as they really need to make an informed decision.

[PaDUer]

26. The doctors LIED to us women

They've RUINED my life as many of you already know..I have autoimmune illnesses, stroke, and now the last 2 MRI's show an angioma in my brain and other problems..I go to the neurologist in Phila on Monday. There's no cure for me, I live in pain 24/7, I was a professional and now I can't work anymore..I can't afford my meds. You don't have any idea the hell I'm living and now I'm declining fast..Yes, the women are dying, and you'd never know they were ill, such beautiful women...Thanks to our leaders in DC, and BTW, Bush has stock in Baxter, Dow filed bankruptcy---my ass, they have DEEP pockets and know the silicone is killing us..What these manufacturers, plastic surgeons, and the govt did, is a scam and a lie. They've never even tested a person! And, yet they're selling saline implants, that ALSO has a silicone shell, which bleeds within 3 hrs on a sheet of paper...the drs are LYING to the women for MONEY!

[Time for change]

43. I'm very sorry that this happened to you

The relationship between silicone gel breast implants and auto-immune disease is rather complicated and difficult to get a handle on. At this time it is believed that the current evidence is insufficient to make a definitive connection. Yet, as noted in the OP, there is evidence that fibromyalgia is caused by ruptured silicone implants, and some believe that that disease has an auto-immune basis.

why do you believe that your breast implants caused your auto-immune illness and other problems?

Thank you for sharing this with us.

[Silicone survivor]

69. Very few Dr's were held accountable

Many Dr.'s were not told the dangers that the manufacturers were withholding. Dow has been found guilty of fraud, let's not forget that.

[Time for change]

22. Here's a worse example -- truly shocking IMO

This involves a stent graft for the prevention of ruptured aortic aneurysms. This is a highly fatal event -- over 50% fatal easily.

An FDA scientist did a study on this device and wrote a manuscript on the findings, which involved situations where the graft would slip, allowing blood to seep around it and fill the aneurysm, thus causing the aneurysm to rupture.

The manuscript was submitted through channels and approved by the applicable FDA management. Then it was submitted to the leading vascular surgery journal and accepted for publication.

But before it could be published, the manufacturer of the device found out about the article and complained to the Commissioner, which resulted in a squelching of the article.

But luckily a reporter at the Wall Street Journal found about it and wrote up the whole story, which appeared on the front page of her paper. Here's the link to the story:
http://www.ahrp.org/infomail/04/07/09.php

[PaDUer]

23. It's about time the FDA tell the truth

and test REAL women, not study their studies...These manufacturers are paying OFF the labs, building them real nice new labs, donating lots of money, trashing doctors offices, stealing patients files, etc., burning drs homes..The FDA needs to tell the truth about these deadly implants that Dow KNEW about years ago and hid the files in another country.

[LSK]

29. duh! cause someone was paid off

Such a silly question!

:sarcasm:

[Jack_DeLeon]

30. Why not? Men and Women have every right to decide....

what they want to put into thier bodies.

[Time for change]

37. So you don't believe that we shold have an FDA?

Any drug or medical device that a pharmaceutical company or manufacturer puts out should automatically be allowed to go to market, without any oversight to determine whether it's safe? We as consumers should take responsibility for making those determinations ourselves?

[nvliberal]

45. No they don't.

There is such a thing as medical ethics.

Going through major surgery in order to implant a device which could pose health problems is not "freedom of choice."

[TOXICDISCOVERY]

33. Toxic Discovery

Our Organization has over 25,000 Members injured by faulty medical devices and perscription drugs. Please view our site and request a FREE Newsletter. We are a Non-Profit. www.toxicdiscovery.com

[Time for change]

42. Thank you for the information

How do you feel that this fits in with the appropriate role of the FDA?

[Silicone survivor]

68. There is no BAN , and the role of the FDA

is to, in my mind, inform and protect consumers. Most people believe that it IS safe if the FDA approves a product. I agree with you.Right now it IS supposed to protect us.
As for the ban mentioned in this site often, there are restrictions, NO BAN, never was. Any woman can walk int a Dr.'s office and get silicone implants. Many Dr.'s are doing them without following the guidelines.
As a leader of a support group, and a survivor, I hear stories all the time about this. One friend was told by her Dr."Enter this study, they will never contact you or follow up, don't worry, you won't have to do anything and still get silicone." Now she is facing a possible late stage detection of breast cancer because an implant obstructed detection. There are so many issues women deserve to know about before making this choice.
I myself was never told the risks. I have been diagnosed with lupus and was one of the women who testified at the last 3 hearings on the dangers.
I think the important thing in this discussion is the process and purpose of the FDA and what services they provide. I know 16 or even 20 year old women who have NO idea that they are not approved OR could even cause problems. We can't assume the average girl has this information and the Dr.'s aren't always giving it. I wasn't. People are also believing the HUGE PR campaign out there. Like many of the posters here. The information needs to get out there.

[Lisa0825]

49. I was working in medical research when the banning took place, and

I remember the doctors in my department discussing the issue. Now, I know a lot of people feel very strongly about this issue, so don't beat me up for this, but I heard from them and from other scientific sources (back then) that the statistics on problems supposedly arising from the implants just did not add up. They basically said that the juries found for the patients out of sympathy and good lawyering, rather than good science. The incidence of problems (they said) were not statistically different than the incidence of those problems in the general female population.

Th OP has vastly different statistics than I have ever seen. I'd like to know the source. Did you write this up yourself, or do you have a link to it?

I am not claiming to be right on this... just reporting what I heard, and I'd welcome any sources that can correct me on it, but would especially prefer non activist sources.

[Rainscents]

56. I am highly allergy to "SILLCONE and PLASTIC, so, if I got one of thoes

implant in my breast, it will be matter of time, I'll be very sick from toxic! Many people don't know they're allergy to these product until it's been installed inside of their body. Many times, allergy reaction can come many months or years later when body finally can't handle the overload! This is the fact and truth!

I was expose to work related toxic and it took many years before my body become allergy reaction to anything and everything! This is call, delay reaction!

[Time for change]

57. You may be confusing breast implant rupture with auto-immune disease

Auto-immune disease is a life threatening illness that is suspected but not proven to be linked to silicone breast implants. Because it is not proven, I do not mention that in my OP.

Breast implant rupture is a very common problem seen with silicone breast implants. Because it is not as serious as auto-immune disease it has not gotten as much attention as auto-immune disease. But it is a much more common problem with breast implants, and though not life-threatening it is certainly life altering.

I refer to two studies by Dr. Brown in my OP. One showed a rupture rate of 55% and an association with fibromyalgia, and the other one showed that 33% of women, over a time period averaging 11.5 years, had problems with their implants serious enough to warrent repeat surgery. Here is a link to an abstract of the latter study: http://implants.clic.net/tony/Corner5/040.htm. Look at abstract MO2 of this link. If you would like the reference to the full article, let me know and I will get it for you, but I don't have it with me right now.

The other study I refer to in my OP talks about the 55% prevalence of breast implant rupture and the association with fibromyalgia. Here is a link to the abstract, but this deals only with the fibromyalgia, not the rupture rate: http://www.jrheum.com/abstracts/abstracts01/996.html. It seems to be very difficult to find links to the full medical articles on the internet.

I don't have the full articles with me now, but if you'd like them, let me know and I'll get the references for you. If this thread is still up, I'll give you the reference through the thread, otherwise please pm me.

[Time for change]

67. Please see post # 66 for the references n/t

[Bridget Burke]

71. What studies did your MD's cite?

The papers will still be available, either online or in a good medical library.

[cally]

50. Could you provice sources for some of your statistics?

The numbers are different than what I've read.

[Time for change]

59. Please see post # 57 n/t

[cally]

61. Thanks...I wasn't aware to this

I appreciate your post.

[Time for change]

66. Here are the full references

Here is the one that talks about clinical consequences of breast implants, including the 33% of women whose symptoms were severe enough to require repeat surgery:
Brown SL, Pennello G. Replacement surgery and silicone gel breast implant rupture: self-report by women after mammoplasty. J Women’s Health & Gender Based Medicine;11:255-264, 2002.

And here is the one that talks about the rupture rate and the fibromyalgia:
Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. AJR 2000; 175:1057-1064.

[Touchdown]

55. What are you talking about? They've been approved for years!

:evilgrin:

[Time for change]

58. Only under restricted conditions

Read the OP

[Touchdown]

63. Well, that flew right over.

I'll try harder on my next joke. :eyes:

[Time for change]

65. Sorry -- I was in so much of a hurry

that I didn't even look at your graphic.:blush:

[ecstatic]

62. And better yet, why is Plan B still not approved?

So they can approve something that is clearly dangerous but not something that is virtually safe (not that much different than regular birth control) even though they claim to despise abortion?

[Time for change]

64. That's the problem -- It's way too political right now IMO

[Silicone survivor]

74. i AGREE

I agree with you. I am so glad to see such interesting information to help people out there. Thanks so much for writing and posting the real information. SO many people think implants are approved, or are totally safe.
Women are still being injured by this product. I hear form them almost every day on my support group and web site.

The FDA precess is turning dangerous to consumers. Not with implants alone. Something has to be done. The FDA is broken and needs to be fixed.

With Big Business supported by this administration,Blan B has been a fiasco. AS has the implant process.
There is so much conflict of interest on the panels and at the FDA it is surprising the revelations have not shocked more people. Now with Crawford's resignation...who knows what?

Thanks for putting up Dr. Lori Brown's research. It is important work. Too bad she wasn't at the last hearings. I heard they were not allowed or asked. Is that true?

[Time for change]

75. Unfortunately, Dr. Brown recently had to move to Washington State

Her husband got a new job there, and she went with him.

She still works for the FDA, but no longer with breast implants. That's really too bad.

However, that's no excuse for not making better use of her research. I don't know the precise rationale which the panel used to recommend approval, or which the FDA appears to be on the verge of using to approve these devices. From my colleague, Dr. Baoguang Wang, who was at the panel meeting and who has been involved in the deliberations, there does not appear to be any good scientific rationale for doing so. It all sounds very suspicious to me.

[Time for change]

76. And welcome to the DU

I think you'll find lots of great articles here if you stick around.