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Wolf begins: "I have heard, in my life, many implausible statements from government officials, but never have I heard or seen anything quite as egregious as what I witnessed as a guest on the BBC's Newsnight program on 7 February 2012."

Author, activist and social commentator Naomi Wolf. (photo: Salon.com)
Author, activist and social commentator Naomi Wolf. (photo: Salon.com)



The Silicone Breast Implant Scandal

By Naomi Wolf, Guardian UK

16 February 12

 

have heard, in my life, many implausible statements from government officials, but never have I heard or seen anything quite as egregious as what I witnessed as a guest on the BBC's Newsnight program on 7 February 2012. Twenty-five frightened and suffering women had agreed to appear in the studio to ask questions of Anne Milton, a health minister for the UK coalition government. They had all been implanted with PIP (Poly Implant Prothèse) breast implants, which had been withdrawn from the EU market in 2010, after revelations of high rupture rates and confirmation that substandard – believe it or not, industrial – grade silicone had been used.

In December of 2011, French authorities advised that these PIP implants be removed; other countries' health authorities took similar action. Britain was not one of them. French authorities, according to the World Health Organization global advisory, "also found that the gel containing non-approved silicone was an irritant to tissue, and when leaking could give rise to inflammation and pain."

When I was researching The Beauty Myth, in 1991, I was reading British medical journals that informed me about the terrible health problems caused by silicone breast implants. I was shocked to see that even as women's magazines were promoting the hell out of them, the medical journals – which women would not see – were offering doctors insurance on implants because the rate of rupture was 30-70%. The side-effects were right there in the journals: up to 70% of implants would harden "like golf balls" and rupture, sending silicone into parts of women's bodies, with unknown consequences.

Similar warnings paid off in the US: silicone implants were banned in 1992. But Britain never followed suit. Now, though, British women like the ones in the Newsnight studio are facing the nightmare that they were never informed of the dangers of silicone by any government body, even as private, Harley Street doctors made fortunes continuing to push implants. And now, with the PIP scare, the NHS is faced with providing millions of pounds' worth of care to remove the implants and give women MRI scans to check for ruptures. It is in this context that I was astonished to hear the health minister say these words to a roomful of scared women:

"The evidence to date is that they [PIP implants] are not [dangerous]."

I couldn't believe my ears, particularly as her department would unquestionably have received the WHO's global alert detailing the PIP implants' greater risk of rupture and tissue-irritant properties of the gel, so I informed her before we taped that the FDA had taken them off the market in the US in 1992, after decades of concerns raised, lawsuits and studies. The FDA's ban had held for 14 years, eventually lifted thanks to industry lobbying in 2006. Nonetheless, Milton repeated her jaw-dropping statement to the panel of women seeking MRIs, the removal of the implants – and just some basic answers.

I confess I blurted out at that point that she was either lying or else in the wrong job. It is inconceivable that the Cameron government – and she herself – did not know about the 1992 FDA ban, which was reported globally. Given the millions of pounds in liability that the government is trying to deflect, it is utterly not credible that she would have not been advised of the nature of that liability; the data on the health risks are unmissable: "If you Google 'silicone breast implant health problems'," I suggested to her; a simple search will give you 14 million results.

In 2011, Saundra Young, reporting on CNN, noted that Mentor and Allergan told the FDA that they had lost track of many patients after implantation. They had promised the FDA that, as a condition of the agency's approval of their implant products, they would follow up with the women who had received them, but – oh dear! – they could only keep track of 21% of those women. In 2009, 318,000 breast implant procedures were done in the US, 70% of those using silicone. Breast implants introduce into your body substances such as denatured alcohol, naphtha rubber, epoxy resin, polyvinyl chloride, talcum powder and acetone, in addition to silicone. Dr Edward Melmed, a plastic surgeon from Dallas, told an FDA panel in 2011 that the implants were an "industrial toxin".

"The symptoms, they are real," he said. "I answer five to seven emails a night from women all over the world, asking, 'What do I do about these symptoms?'"

Melmed told the FDA that by 10 years after patients get them, 50% of silicone implants have ruptured; 72% by 15 years; and 94% rupture by 20 years:

"Why is the FDA continuing to allow a device to be placed in young women that is guaranteed to fail [in] 80% [of cases] in 10 years? Would they allow that in hip replacements? Would they allow it in men?"

Dr Melmed is something of a prophetic figure: a Dallas surgeon who had inserted breast implants in thousands of women, he wrote in the LA Times, in 2007, in "Silicone Implants: They're Still Dangerous", after the FDA rescinded its 1992 ban.

Dr Melmed had enlarged the breasts "of thousands of women with silicone implants since they were first introduced in the 1960s". But he described his patients' appearing with a common problem over time:

"Most breasts with silicone gel implants become hard with time. It's called capsular contracture … Women with capsular contracture often end up with disfigured breasts and pain."

He described patients such a Helen S, 71, whose implants from 23 years earlier had hardened and were causing her pain. An MRI revealed that the implants had ruptured and calcified: "When I removed the implants, the cavity was filled with gooey, liquid silicone that had ruptured; there was virtually no implant wall left." In the past 14 years, he has removed the implants from 1,000 women; he adds, "We are still not sure of all the places where the micro-droplets of silicone end up, though I have found it in lymph nodes."

He points out that every generation of silicone implants have been heralded, like this one, as an improvement. This time, he noted in 2007, the FDA is requiring women to get monitored for rupture with MRIs, and advises replacement every ten years. "It is a pity that women will become the experimental lab rats for these implants," he notes, and points out that they, not the surgeons, will have to pay for the expensive monitoring. Other surgeons aggressively deny any connection between silicone implants and health problems, but Dr Melmed attests:

"I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed."

The implant manufacturers' own literature warns that one in four women will need additional surgery within the first year after getting implants, and many will have multiple surgeries. "Women deciding to have these implants need to be prepared to have additional surgery," cautions Dr Daniel Schultz, head of the Center for Devices and Radiological Health at the FDA.

The women in the BBC studio in London were horrified that no one had told them about the dangers. They kept saying, understandably, "How could the government allow this to happen?" They kept asking, "Where are the tests?"

The tests have not been done because of financial pressures not to know and not to tell women what dangers await them. The real boondoggle is not that it costs under $600 in the UK – a relative bargain – to get silicone breast implants; it's that it costs $3,000-8,000 to remove them, or to have repeat surgery for ruptured or hardened implants. The very defective nature of the implants – about which women are not adequately informed – guarantees a surgeon lucrative future procedures from that same woman, as her implants harden and rupture over time.

The "Oops, we forgot to tell you what these things do to you" approach extends to the US. In 2007, when implants were pushed back on the market, the FDA – seeking to appease the chemical industry and the surgeons' lobby – compelled manufacturers, as a condition of approval, to spend a decade studying the 80,000 women who were now being given implants. This was bad enough; as Dr Melmed puts it, at that time, the government's policy was implant now, study later. At the rates that women are seeking breasts implants, five US women in every 100 will have the devices in their bodies in a decade.

So, what has happened since? Surprise: the manufacturers failed to follow through, but sold the hell out of the devices anyway. There are strong vested interests in not compiling this data for the purpose of government scrutiny; indeed, the US and the UK authorities are cynically looking the other way. The FDA's response to the industry's failure to comply with the clinical record-keeping it had undertaken as a condition of the lifting of the ban has been merely to note that it would think about this situation and not take any action without consultation with, creepily enough, surgeons, patients and "sponsors". Before the FDA was wholly owned by special interests, its mission was to protect the safety of patients, not to appease financial stakeholders.

So, a new generation of women will not have access to critical government studies that would otherwise confirm the overwhelming evidence of the health problems associated with silicone implants. Why is it always women who are treated as guinea pigs and their bodies like lab rats'? I guess because there is a cultural assumption, which, in effect, the UK government deployed last week in public, that women deserve no accountability, especially if you can blame the issue on their "vanity". Anne Milton and her colleagues in the Cameron government must think women are either really stupid or really worthless, since they – like my own government – apparently feel no obligation to protect women from special interests profiting at the expense of their health.

 

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+74 # LeeBlack 2012-02-16 12:40
It may be that too often problems with breast implants are overlooked by the general public because the impression is that these are silly women who wanted to look sexier. However, breast implants are often done after breast cancer surgery by hundreds of thousands of women and problems with silicone should be addressed,
 
 
+33 # Daisy 2012-02-16 13:17
Though I had an implant due to breast cancer, it was not silicone for that reason. And it was 1999 here in Chicago at Rush. A year or two ago, I saw a show that included a woman wrestler whose breast implant burst during a match. Didn't mention whether silicone or not. However, it would seem that a severe impact on the implant can cause bursting too. Another thing to be aware of.
In her case, the implants were, like many entertainers, to enhance her career opportunities.
 
 
+14 # stiver-aloha@hawaii.rr.com 2012-02-16 14:51
Thank you, Lee Black. As a man, I'd much prefer that a woman go with what Mother Nature gave her unless the valid reason you cite prevails. I don't know statistics, but questions abound: I wish Ms. Wolf had, for example, told her readers (i) how many women (or as a percentage of all women) over, say 18, have had breast implants (the article conjures up MILLIONS to me!)of any shape, form, or ingredient; (ii) how many of those were necessary for reconstructive purposes; (iii) how many of those were for cosmetic ("sexier") reasons; (iv) in simple subtraction, how many have not availed themselves of implants of any sort. It might be very interesting to do such a sampling by country: US, Britain, France, Italy, Spain, Russia, Germany, Norway, Japan, China.... My wife is Japanese, implant-free, and my general impression is that, notwithstanding the occasional exception, Japanese women are very comfortable with their own bodies as they were given to them, unenhanced, natural, proportional... . Part of any study could be: is this phenomenon a Western-driven, narcissistic blot on humanity (with both women and men involved in blame) with greed/profit a major component?
 
 
+9 # John Gill 2012-02-16 16:27
Stiver, you might be surprised at the prevalence of cosmetic surgery in Japan. If anything, Japan may be even more image oriented than the USA. I believe statistics indicate that more young women in Japan per capita receive plastic surgery than here, and a growing trend there is for cosmetic surgery on children, whose parents want them to gain an early advantage socially. Narcissism is really more human than region, I think.
 
 
+9 # futhark 2012-02-17 01:34
I'd like to see some really objective poll about the percentage of men who prefer women with "bolt-ons" as opposed to those who find natural women more attractive. I think the results would surprise many and would not be welcome news to the plastic surgeon community.
 
 
+23 # John Gill 2012-02-16 15:02
I think you hit very close to the mark here. The lack of attention paid to this issue is very much because women who want to look sexier are dismissed as silly, vain creatures.

We should find this practically incomprehensibl e, living as we do in a society where purveyors of consumer goods and services engage in everything short of waterboarding people into believing that the "sexy" image is as indispensable as breathable air.

This is not entirely a double standard, either: 50 year old men who drive fast, red cars are also taken less seriously by the general public.

But if tomorrow, hair transplants were deemed toxic and causing difficulties with personal appearance, pain, and associated health problems, you can bet the farm there would be a bi-partisan crush to push through a Senate investigation of the matter.

Severe penalties would be imposed on all responsible parties, and all this at the behest of a ravening mob of furious male lawmakers, (who would, coincidentally, be bringing the wearing of hats, quite suddenly, back into vogue).
 
 
+13 # Floridatexan 2012-02-17 05:35
Judging from the current Congress, one might expect powdered WIGS!
 
 
+18 # pbbrodie 2012-02-16 19:18
I nearly clicked a positive for this comment and then it dawned on me that the author of this comment is doing the same thing that the government authorities are accused of, and agrees that the women wanting to look "sexier" don't deserve the same treatment as those getting breast reconstruction after breast removal due to cancer. I say bullshit to that. Anyone having surgery for any reason deserves the same information and honest treatment! Problems with breast implants should be addressed no matter what the reason was the patient had the implant! Shame on you.
 
 
+57 # Barkingcarpet 2012-02-16 12:55
Our leaders are mostly insane and looking after their own profits.... Time for a new system based on taking care of each other, all of nature which sustains all life. Money is worthless without health, and reducing the world to dollar values is reducing everything to toxic landfills.
Yes, WE can. Lets take the world back from the criminally and ignorantly insane leaders we currently have.
 
 
0 # Cambridgemac 2012-02-20 14:32
Exploding breasts, the pumping of toxic chemicals into the groundwater via fracking, the preparation for a war of aggression against Iran, the winking at hundreds of thousands of cases of mortgage fraud, the steady push to dismantle Social Security, and so on. At first I thought your use of the word "insane," when describing our "leaders," was a bit extreme.

But it's apt.
 
 
+32 # maddave 2012-02-16 12:58
As a male, all I can say is that this situation is truly unconscionable. Anyone who knowingly advocated or implanted these time bombs - for profit - needs to be drummed out of the medical profession.

That said, the article is somewhat of a disappointment: I was hoping to see an expose regarding what appears to be Newt Gingrich's surreptitious boob job.
 
 
+40 # Buddha 2012-02-16 13:23
A for-profit health care industry, making money by cutting corners and thereby putting people's lives at risk? Nah, that kind of stuff can't happen in the developed world, can it? Um-hm.
 
 
+41 # lcarrier 2012-02-16 13:24
The Cameron government in the UK is disgusting, as is Harper's government in Canada (where pollution reigns in the Alberta tar-sands project). Why people keep electing these miscreants would be inexplicable, except for the Murdoch publishing empire and its look-alikes who keep the lies flowing and the public sadly misinformed.
 
 
+43 # marigayl 2012-02-16 13:29
What almost always goes unmentioned about breast implants are two vital realities:
1)breasts that are implanted can never be used to nourish babies--nursing is out.
2)breasts that are implanted are essentially deadened, and can never again enhance that woman's sexual pleasure.
What does this say about the deluded women who deaden their own feelings and destroy their own life-enhancing function in order to make of themselves the sexual fetishes of a certain kind of man?
And what does it say of the men who continually post pics of women with spherical, unreal-looking, silicon-enhance d breasts as their own personal turn-on? Do these masturbatory fellows cherish the notion that the sexual experience is intended to be a pleasure only to themselves?
 
 
+7 # John Gill 2012-02-16 15:55
Hey, lol, how 'bout a little human understanding? We all suffer from delusions of one sort or another, and although I happen to be one of those warm fuzzy guys who read the articles in Mothering Magazine with an avidity equal to my wife's as we anticipated the birth of our kids, and pretty much agree with all your positions, the issue here is one of immanent danger to these women, and if even folks on the left callously dismiss them as dupes, it becomes that much harder a cause to prosecute.
P.S. "masturbatory fellows"? please.
 
 
+1 # Floridatexan 2012-02-17 05:36
Yep.
 
 
+1 # tallgirl 2012-02-20 18:47
I'm all for telling the truth about breast implants, including that they can and do fail with alarming regularity.

However, it's not true that augmented breasts cannot nurse, or that all augmented breasts wind up "deadened".

There are techniques that are utterly insane and need to be banned which can have those side-effects, but there are other techniques which don't. The problem is that the higher-risk techniques produce fewer noticeable scars and doctors are, in my opinion, unethically promoting those techniques over something safer.
 
 
+44 # ganymede 2012-02-16 13:34
Almost every day we read of one medical disaster after another. This product fails and is recalled; such and such a surgical procedure is killing a lot of people; people like Whitney Houston are routinely killed by taking and mixing too many drugs, mostly legal, and so on. It is safe to say that despite many miracle drugs and worthwhile surgical procedures, the healthcare system in all western countries is probably doing more harm than good. In America, which is one of the few countries that allows pharmaceutical co's to advertise prescription drugs directly to the public, abuse is now worse than many other advanced countries that have universal healthcare. Unrestrained profit in the health business isn't really very healthy!
 
 
+18 # CL38 2012-02-16 16:33
.....and these kinds of abuses are a result of the excesses of capitalism and corporate/pharm aceutical/healt h care industry greed that needs to be EFFECTIVELY reformed and controlled.
 
 
+6 # Floridatexan 2012-02-17 05:39
Thank you for mentioning the idiocy of pharmaceutical advertising to the general public. After being informed of the possible complications from these drugs, you'd think people would be smart enough not to take them. You'd be wrong.
 
 
+11 # Floridatexan 2012-02-17 05:51
Did anyone catch the Dr. Oz show with Suzanne Sommers? She had breast cancer and had to have reconstructive surgery. The doctors used stem cells to regrow her breast tissue! She was kind enough to allow a recap of the procedure with images. This could be a real lifesaver for many women. As for the women who have these implants for "cosmetic purposes", I feel sorry for you. It seems the medical community waited just long enough for everyone to forget about the side effects associated with the previous ban. DON'T DO THIS TO YOURSELF! It's NOT WORTH IT!!!

"I confess I blurted out at that point that she was either lying or else in the wrong job..." I absolutely love it! You GO, Naomi!!
 
 
+43 # angelfish 2012-02-16 13:43
God KNOWS that if they were using faulty silicone in their Penile Implants SOMETHING would have been done Immediately! The whole story makes me sick to my stomach!
 
 
+21 # bugbuster 2012-02-16 13:49
Maybe the most effective way to fight back is to spread it all over the net that breast implants per se are a health risk, that there are no safe breast implants, and that they all give you cancer.

Somehow, inexplicably, we are here. We are here even though our ancestors didn't have breast implants. Imagine that.

More likely we are here *because* our ancestors didn't have breast implants.
 
 
-28 # sandyboy 2012-02-16 13:59
I have never seen anything so egregious as Ms Wolf's appearance on Newsnight. She was rude, talked over everyone else and accused the minister of deliberate lies, as she admits here. Yes, it's a scandal. But the UK government has said the National Health service will remove implants - what they will not do is then pay for replacements. Many of the ladies in the studio DID have implants for vanity reasons. Yes, politicians do lie as we all know, but Ms Wolf's ranting and noise only gave ammo to those who think female activists are incapable of calm discussion and actually may have harmed her cause with impartial viewers.
 
 
+13 # Torvus 2012-02-16 16:13
Thank you for this clarification. Nevertheless the Health Minister persisted in denying that there were health risks with PIP implants, even though ". . . her department would unquestionably have received the WHO's global alert detailing the PIP implants' greater risk of rupture and tissue-irritant properties of the gel . . ." These health risks had been known - at least in medical circles - for at least a decade. The Health Minister's denials and/or the Ministry's ignorance are shocking. We sure can't trust them. And unnecessarily putting permanent foreign substances in your body is madness - operations should be avoided if at all possible.
 
 
+25 # CL38 2012-02-16 16:38
What utter claptrap BS!!

The only way to be heard over the rampant institutionaliz ed misogynistic policies that dominate the world's governments, institutions and 'religious' organizations is to SPEAK UP and demand to be heard. More often than not, this requires a willingness to be 'rude' and to talk over others who are trying to drown you out and shut you up.
 
 
+11 # Floridatexan 2012-02-17 05:53
Sandyboy, you must work for the government. And exactly how do you know why these women had implants? What Ms. Wolf did is shine a light on the truth. You should try it sometime.
 
 
+18 # Susan1989 2012-02-16 14:05
It amazes me how women are so easily sold on the idea that they have to alter their appearance in order to be loved and appreciated. This is a huge lie perpetrated by our culture which is damaging our young women.
 
 
+14 # Futilitarian 2012-02-16 16:31
Quoting Susan1989:
It amazes me how women are so easily sold on the idea that they have to alter their appearance in order to be loved and appreciated. This is a huge lie perpetrated by our culture which is damaging our young women.


To me, it is such a shame that women are moved to feel the need for this procedure, even those post mastectomy. I'm sure I don't completely understand and as a male, i may not be capable. I will state, so that maybe one fewer women will seek implants, that I have been with women both with and without implants. Those women without implants are far sexier than those with implants. To me, natural is sexy and attractive regardless of size. I know that I'm in the minority viewpoint of the male population and I'd also like to apologize on behalf of my male brethren for foisting this distorted culture upon women, convincing them that they must have large breasts to be of value and beautiful.
 
 
+28 # uuzul 2012-02-16 14:46
There is a further HORROR. Johnson & Johnson is using the SAME silicon to make 'new' contact lens (Acuvue Oasys & Advanced). When the doc gave them to me, he forgot to mention they were silicone and he certainly forgot to mention the terrible side-effects of putting the same goo in your eyes as the ladies had in their breasts. I was SO SICK! Like MANY other people who put them in their eyes. There is a call for a lawsuit against J&J. (Not only contacts, but other devices like stents & pacemakers!)
 
 
+24 # CL38 2012-02-16 16:41
This is yet another reason to get the greed and health insurance industry and special interests out of our medical care.

Single payer coverage (like Medicare) for all!!!!
 
 
+11 # colvictoria 2012-02-16 18:02
uuzul this is so disturbing. I am reading one of Dr Mark Hyman's books and he writes that many people have mercury contamination. This is due to having had mercury amalgams, vaccinations as well as using contact saline solution which contained Thimerosol a preservative which contains mercury. So the combo of having silicon plus mercury from saline is double trouble for our poor eyes plus our brains!
 
 
+10 # Activista 2012-02-16 15:49
Sick money culture and greedy doctors - implants are perfect symbols of our society.
 
 
+17 # sasha56 2012-02-16 19:21
This is an issue near and dear to my heart and I mean that literally. 10 yrs ago, I was one of those "silly, vain women" who underwent breast augmentation with silicone implants to correct a distinct asymmetry issue that had been bugging me for years. 10 years later after some research into the prospect of getting them out, I was shocked at the frightening stories of complications associated with both saline and silicone implants, and the misinformation solicited by plastic surgeons and the manufacturers of the devices-(75-80% rupture within 10 yrs, but your doctor will never tell you this) When interviewing surgeons requesting an explant procedure, I was told over and again how 'safe' the new devices are, and was discouraged from simply removing without replacing them.
Silicone poisoning is real. Considering the millions of women who have implants, I wonder if there will ever be any legal recourse to hold the industry accountable. I expect we will hear many more horror stories in the coming years. Class action lawsuits??
 
 
+1 # Cambridgemac 2012-02-20 14:36
Interesting that Republicans want to "inform" women about abortion risks - including vaginally penetrating women for no health reason at all - but can't get interested in having patients informed about a procedure that fails 75% of the time....
 
 
+3 # RLF 2012-02-17 04:09
It's a good thing we have a progressive president in office so that dangerous products don't get forced back on the market just to insure corporate profits!
 
 
+6 # sandyboy 2012-02-17 07:14
CL38 and Floridatexan: No, I don't work for the government, I loathe it. It's crazy to say you must be rude to stop people drowning you out - nobody tried to silence Ms Wolf, it was HER who ranted and wouldn't let anyone get a word in. How do I know some of the women on the show had implants for vanity reasons? Cos they said so! D'oh, how did you think I knew? I'm with those women who say never have an op unless you NEED one. Reconstructive surgery is one thing, vanity is another. All implants are dangerous. But let's be clear: the folks behind the use of industrial silicone in implants must be jailed.
 
 
+3 # sandyboy 2012-02-18 03:47
Here's an update: nearly 3,000 women who had PIP implants privately have been referred to the UK health service, but most of them REFUSED the offer to remove them after talking to doctors! It wasn't going to cost them either - the government would recoup the money from the original clinics.
 
 
0 # boudreaux 2012-02-22 12:01
I was unfortunately one of those women who had to have brest surgery in 1989 and had to wait for 6 months before reconstruction could be done and was never asked what kind on implants I wanted and being ignorant of silcone implants they put them in with me thinking they were the best. I had them in for about 6 months before they started hardening and looking totally horrible, denting and and making me feel like a freak. I got into the implant law suit and they at least paid for them being removed but not to put the saline ones back in. I was fortunate enough to find a plastic surgen that charged me $3500.00 to have the new ones put in and have had them in now since 1996 and have no problems with them. I was pissed off to say the least about them but thankful for the law suit that helped some. I hope that they will finally do something to take them off of the market b/c they are nothing but trouble and should be banned from being used at all. This is a terrible thing to do to a woman and should to removed from ever being used on any woman.
The reason that I had them put in was not vanity but is the only physical difference between a man or woman and I wanted to feel like a woman again. If there was another way for me to have them done so that I would not lose feeling in them I would have done it. I miss that feeling when being intimate but it is what it is now....
 

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