Should you have a breast implant? In the end, you will make that decision. But it’s best if you read this article about Imogen Thomas, ‘toxic’ PIP implants and what you can learn from this.
Welsh beauty queen, glamour model and TV personality Imogen Thomas, who rose to fame after winning the 2003 Miss Wales title and lasting three months on the seventh series of Big Brother is also famous for one other thing: her big and beautiful breasts.
The thing is, they’re fake — but the 30-year old sex symbol isn’t shy about letting the world know. In 2008, the reality star announced that she would be getting a boob job. “As a model, appearance and feeling good about my body is very important to me,” she told the Swansea Evening Post.
“I am so happy with my new breasts and they look really natural which I am so pleased about! This is going to give me the confidence to go on to even bigger and better things! she enthused.
But who’s to sneer at or judge her? Big breasts have always been considered attractive and have been in fashion virtually forever — except for a few odd times like in the 1920s Flapper era, the 1960 and the 1990s.
This growing demand for big boobs is caused by a rising “culture of perfect beauty” being spread by show biz, the fashion industry and mass media. It’s what drives the consistently strong growth of the global cosmetic surgery industry — as well as the thriving illegal trade in dangerous cosmetic procedures carried out by unlicensed medical practitioners in backrooms across the world.
In 2008, more than 340,000 American women and teenagers had breast implant surgery — triple the figures from 1997– according to the American Society for Aesthetic Plastic Surgery. Breast augmentations continue to rank as the No. 1 cosmetic surgery in 2011, the ASPS says. Worldwide, the U.S. Food and Drug Administration estimates that five to 10 million women have breast implants — both as a cosmetic procedure, as well as a corrective surgery after mastectomy to treat breast cancer.
Breast implants are medical devices that are used to augment breast size or to reconstruct the breast to correct a congenital abnormality or following a mastectomy. Implants consist of a silicone outer shell and a filler — most commonly silicone gel or saline.
What many of these women who have breast implant surgery don’t know — or don’t fully consider — is this: breast augmentation is just like any other surgery. As such, it carries the same risks as all surgeries do — including the possibility of death.
Doctors and health experts enumerate these complications of breast surgery and silicone or saline implants:
• surgical risks
• anesthesia risks
• scar tissue
• breakage and leakage
• necrosis (skin death)
• infection (bacteria and mold which can be released from the implant into the body)
• chronic breast pain,
• breast or nipple numbness
• capsular contracture
• hardened and misshapen breasts
• arthritis and joint pain
• memory loss
• cognitive impairment: poor concentration
• metal poisoning due to platinum exposure (in silicone implants)need for additional surgery to deal with problems
• dissatisfaction with how the breast looks
• silicone migration into lymph nodes and other organs
• debilitating autoimmune disease such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective-tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia.
All breast implants leak
The ongoing global scare over defective PIP silicone implants — sold to almost 400,000 women across the world — brings to fore the risk of breast implants breaking and leaking.
All breast implants eventually break, with most implants lasting from seven to 12 years, according to studies silicone breast implants. But some may last more than 15 years, but others may break during the first few months or years.
Ruptured silicone implants can be painful and when silicone leaks into the body, it can cause health problems.
When an implant breaks, silicone gel will leak. Leaking silicone can be contained in the thick layer of scar tissue that naturally builds up around the implant. The FDA itself warns that when silicone stays within that scar tissue capsule, it causes inflammation and a painful disorder called fibromyalgia.
If the rupture isn’t addressed, the scar tissue can lead to pain and changes in breast shape — but at least, there’s no scientific evidence that ruptured silicone implants cause serious, long-term health problems like breast cancer or connective tissue diseases, the FDA has assured, way back since the silicone implant scare of the 1990s.
But sometimes silicone gel will leak outside of the scar tissue capsule and migrate to other parts of the body — the lymph nodes under the arm and major organs like the lungs. There, it’s impossible to remove. That’s when it becomes dangerous. Again, doctors say there’s no evidence of an increased risk for cancer.
One complication is that women usually won’t notice that their implants have ruptured and are leaking. When this happens, the chances of silicone traveling in the body, causing more health problems, also rise. It’s also more difficult to remove an implant once it has ruptured — and again, surgery to remove it carries the risks involved in having surgery — infection, bleeding, and reaction to the anesthesia.
PIP breast implant poses more risks
So it’s inconvenient and costly when a breast implant leaks but there’s no serious health threat, right? Yes, BUT that’s only what the FDA assures for implants made with medical-grade silicone tested by global health agencies. With the defective PIP implants, there’s a yet unknown health risk from their use of non-medical grade silicone, French health authorities say.
And anywhere from 300,000 to 400,000 women from 65 countries are at risk. These are the women who have had breast implants — whether for cosmetic purposes or to replace a breast lost to cancer — using a silicone implant made by the French company Poly Implant Prothese (PIP). Before French authorities ordered it closed in 2010, the company produced PIP silicone gel implants that were snapped up by surgeons across the world because they were the cheapest.
South America accounted for more than half the exports, but a huge chunk of PIP breast implant sales also went to Europe.
Anxiety over the safety of PIP breast implants spread across the globe last December when French health authorities advised some 30,000 French women to have their PIP implants removed because these had a higher tendency to rupture. French authorities had even offered to pay for these removal surgeries.
The announcement was made at the end of an official probe into the PIP breast implants, begun in 2010. The investigation found that while all breast implants have a “shelf life” of at most 10 years, the PIP implants have a higher rupture rate of five percent.
Mechanical testing by the French Health Products Safety Agency (Afssaps) also showed that the implant covers had an increased risk of breaking — Affssaps registered 1,143 actual ruptures and 495 inflammatory reactions from the implants.
The French inquiry also found that since 2005, PIP implants were not using medical-grade silicone that’s approved by French health authorities — as well as the FDA and other global health bodies. The company even stopped using a protective barrier in its implants.
Health and drug regulation agencies in most countries require manufacturers to make silicone gel breast implants out of medical grade material that’s passed safety tests for human use. PIP implants, the probe found, were made from material intended for use in mattresses.
Since the news that industrial grade silicone was used in the PIP implants first broke in 2010, a number of a countries have since banned the product: France, the United Kingdom, Netherlands, Czechoslovakia and many other European countries, as well as Latin American countries Brazil, Venezuela, Argentina and Colombia.
PIP implants: worse than they thought
But while health authorities across the world thought that only women who had boob jobs between 2005 and 2010 were at risk, in the past few weeks, it’s emerged that women have been receiving defective PIP implants since 1997.
Earlier, PIP had admitted to making implants with the substandard, industrial-grade silicone gel that had caused an increased risk of rupture — but only after 2001.
But last month, Dutch investigative TV program Zembla discovered that “several hundred” women received PIP implants since 1997 — prompting the Dutch government’s health watchdog to recommend the removal of PIP breast implants used in women in surgeries done before 2001.
“Women who had a PIP breast implant before 2001 should have themselves examined by a doctor and, in consultation, eventually have the implants removed,” the Dutch Health Inspectorate (IGZ) said in a statement. “Until now, the IGZ believed that only Dutch women who received the implants from 2001 onwards were at risk,” the IGZ added.
Earlier on January 11, Dutch authorities recommended the removal of PIP implants done after 2001 — from around 1,000 women in the Netherlands. It said it would pay the full costs of the removal.
In UK, a further 7,000 women may have fallen victim to the PIP breast implant scandal, the government in that nation revealed, following tests that showed substandard silicone was used to fill the implants for much longer than had been thought.
British health secretary Andrew Lansley said on March 15 that women who were given PIP implants before 2001 may also want to see their surgeon or GP to have these removed — although some of the implants will have been removed by now, given a normal lifespan of around 10 years.
“The French regulator has confirmed this week that more women may be affected by the criminal activity of the French breast implant manufacturer PIP,” Lansley said in a statement, assuring women that the National Health Service will provide them with help — in getting their faulty implants out as well as seeking legal remedies from the private clinics that put them in.
Brazil: tougher regulations
Meanwhile, Brazil — the world’s cosmetic surgery capital — announced on March 22 that it would introduce tightened controls on sales of breast implants. According to Anvisa, the national health protection agency, these will include lot-by-lot testing — as well as a new requirement that authorizes the national quality control institute Inmetro to certify implants after ensuring their absence of toxic substances, tear resistance and physical strength.
The stricter regulations will apply to any new implant product about to be brought to market in Brazil. Once their five-year licenses come due for renewal, existing brands will also be subject to the stricter checks, the Anvisa said.
Implant manufacturers will be able to choose between additional onsite inspections of production processes — that will come on top of routine factory inspections by Anvisa or certification through on-going pre-market tests on batches of their products.
Around 25,000 implants produced by now-defunct and bankrupt PIP were sold in Brazil, but were taken off the market in December.
In neighboring Venezuela, the government has since offered to cover the costs of removing the PIP implants — but said it would not pay for replacements.
Columbia has also said it will pay for the removal of flawed implants, in cases where these have ruptured and caused a medical emergency, or when a doctor recommends removal. Some 15,000 women have PIP implants in this Andean nation.
In Argentina, the number of women who have received PIP implants is unknown, but about 13,500 of them were imported from 2007 to April 2010, and today 50 women are suing plastic surgeons who used these items to force them to replace these, Reuters reported.
In December, after issuing inconsistent advice, the UK health authorities also agreed to pay for the removal of PIP breast implants from 3,000 British breast cancer survivor-women who had had a breast implant surgery at the National Health Service as part of reconstruction after partial or complete mastectomy.
Like in Columbia, British health authorities also cleared the way for up to 47,000 private patients to have the PIP implants removed at taxpayers’ expense — but only if there is a clinical need. The NHS does not perform cosmetic surgery, which is usually done in private clinics.
Earlier this month, PIP’s former owner Jean-Claude Mas was placed in jail after missing a bail payment. He is facing both civil suits and criminal charges of bodily harm in France. Hundreds of women in France, Venezuela and elsewhere are preparing to sue surgeons and importers of the implants.
Imogen Thomas doesn’t have PIP implants
As for Imogen Thomas, she’s spoken out about her relief at finding out she does not have “explosive” PIP breast implants. On January 23, she tweeted: “I’ve just found out I do not have PIP implants. So happy 🙂 thanks @mya_tweet xxx”
Some celebrities haven’t been as lucky. Former Miss Great Britain Gemma Garrett has had to have her implants taken out — and she’s since spoken out candidly about this, warning young women against breast augmentation. Her initial breast enhancement cost her over £4,000 and the removal last year another £11,000, she said.
My surgeon told me “there was silicon in my blood system. He didn’t know the lasting effects it would have on my health — that’s still being investigated –but it is scary that they are telling some people not to worry about it if it hasn’t opened up,” she told BBC News.