Ruptured lives.................
Seven years ago, Bronwyn Pereira made the decision to have silicone breast implants to finally conquer what she describes as an embarrassing hollow chest. Pereira, a fit mother of three from Sydney's northern beaches, has a condition called Pectus excavatum, a congenital deformity of the anterior chest wall.
"I used to wear T-shirts when swimming to hide this. As a teenager I could not wear anything strapless or low-necked, let alone sustain a normal teenage romance." Pereira, 47, chose implants made by a French company, Poly Implant Prothèse (PIP), after being advised by her surgeon that their shape was ideal for her condition. She was reassured that the brand was safe; at the time it was the third-biggest seller on the international market.
Pereira was one of more than 5000 women affected in Australia, many of whom had no idea of the international recall, which the federal health watchdog, the Therapeutic Goods Administration (TGA), had posted on its website at the time. Many women were not contacted by their surgeon about the recall. It wasn't until 18 months later, when news broke around the world that a French woman had died from a rare blood cancer after her PIP implants ruptured, that it dawned on Pereira that something could be seriously wrong with her implants.
Then, in June 2012, the UK Health Department released its findings in a study that concluded PIP implants were two to six times more likely to rupture than other brands within five years of surgery. The French government announced it would pay for 30,000 women there to have them removed. Several other European countries followed suit - more than 400,000 women in 65 countries have received PIP implants - but the Australian and the UK governments have advised against removal if there are no signs of rupture.
Pereira realised that the chronic fatigue, heart palpitations, night sweats, shooting chest pain and headaches she had endured for two years since early 2010 - and which she had put down to the daily grind of motherhood and work - were quite likely the result of leaking implants.
An ultrasound revealed the encasing on one of Pereira's implants had multiple ruptures and the silicone had spilled throughout her chest, all the way up to her shoulder. She had four-hour surgery to replace them and to ''fish out the worms of silicone'', as she vividly describes it. After persistent pain in her armpit, she had to have further surgery to remove more silicone, which resulted in the unplanned removal of eight lymph nodes: they were engorged with the gel.
''I couldn't believe it ... in the middle of the surgery [the breast surgeon] had to access French and US websites as to how the hell to deal with this. Should the surgeon leave it? Should she take it out? What are the ramifications of this crap going into my lymphatic system? She told me she was gobsmacked, absolutely shocked to the core."
Now, as she lifts her arm to sip from a coffee, long, tight, fibrous ''cords'' pull from her armpit to her neck, and all the way down to her wrist. ''It's like being a puppet on a string."
Pereira drops her slender shoulder and stretches her neck, describing how the ''cording'', or axillary web syndrome, squeezes her jugular veins, sometimes making her dizzy. The cording Pereira suffers is a side effect of the surgery, which left her with 35 per cent movement in her right arm for several months.
PIP's owner, Jean-Claude Mas, is currently facing trial for aggravated fraud in relation to the sub-standard implants in what is the largest and most expensive trial in recent French history. While Mas may be jailed for up to four years, Pereira faces a lifetime of compromised immunity. ''It has turned into the biggest regret of my life," she says.
Pereira's ordeal was echoed by many Australian women at a Senate inquiry last year into the TGA's role in the scandal. The women spoke of being unable to work or properly care for their children due to a plethora of health complaints and the accompanying financial and mental stress.
Many of the women in Australia who had PIP implants were shocked and angry that their surgeons failed to contact them until January 2012 (well after the April 2010 recall), when the TGA conducted a phone and registered mail blitz to surgeons it believed may have used the implants, urging them to contact patients.
The inquiry was critical of the watchdog's slow response and lack of transparency, and of its lax regulation of breast implants, which are registered as a high-risk Class III medical device. It also noted it took the federal government almost two years to set up a free MRI service for affected women, and for the health department to convene an expert clinical group and establish a national hotline, which received almost 4000 calls in the first three months. As of January 2013, the number of PIP ruptures voluntarily reported to the TGA stood at 451.
At the very least, the scandal has exposed a massive shortfall in record keeping, as the TGA scrambled to gather data on the number of PIP implants used here (a voluntary registry only captured 4 per cent of cases).
The TGA says routine removal is unnecessary because scientific testing in the UK, France and Australia has so far shown the non-medical grade silicone is not toxic or carcinogenic, and that the risks involved with the use of PIP breast implants are no greater than those for any other brand of silicone gel-filled breast implants.
But not everyone is so confident, including the president of the Australian Society of Plastic Surgeons, Dr Geoff Lyons, who warns it is still early days and investigation is ongoing. ''This is a huge potential medical health issue,'' says Lyons.
The TGA's stance on the implants leaves Pereira fuming. ''They didn't have the bright orange gel sucked out of their body. It was horrendous,'' she says. ''I am immune-compromised and I will be for a long, long time, so there are ramifications that I don't even know of yet."
Her fears are backed up by WA plastic surgeon Dr Tim Cooper, who has conducted extensive research on the implants in Australia. ''No one knows the carcinogenic potential. My consistent message is, 'Get them out'. If you're going to withdraw it from sale, then why leave it in the body? It's like waiting for the Titanic to hit the iceberg.''
Cooper first became aware of the issue in 2009 after he removed a ruptured implant, which had leaked into the woman's lymph nodes ''like liquid pus'' and caused inflammation in her breast tissue. ''I was thinking, 'This is weird, is there bacteria in it?' You wouldn't expect to see yellow soup. The implants looked like somebody had put a bomb under them and they exploded."
Cooper implanted 138 women with PIP implants in Perth between 2005 and 2008 and has spent the past two years removing most of them. The procedure, normally done in a private hospital at a cost of between $10,000 and $15,000, is only covered under Medicare in limited circumstances and only for removal, not replacement.
''The TGA need to be held to account for their public message, which was always, 'Don't panic, there's nothing wrong with these implants', " says Cooper. "That's what annoys me. They are very defensive.''
The TGA insists, in the face of international scientific research suggesting otherwise, that the PIP breast-implant rupture rate in Australia is only ''slightly higher'' than other brands. But this assumption is based on rudimentary data - there have been 451 voluntary reports of ruptures among the 13,200 implants supplied, giving a rate of 3.4 per cent.
In February this year, Cooper released findings showing a device rupture rate of 17 per cent after 4 1/2 years. The data was based on a sample of 144 patients with a total of 269 PIP implants, 45 of which had ruptured. "We have proven they have a much higher rupture rate, contrary to what the TGA says."
Sydney plastic surgeon Paul O'Keeffe says he stopped using PIP implants a few years ago after three of 20 patients he had operated on had ruptures. He kept a record of all the batch numbers and says it was clear which implants most likely had industrial-grade silicone - those that had ruptured. ''It was only apparent when the thin oil had time enough to get out of the gel and weaken the shell, just like water weakens blotting paper," says O'Keeffe. "The thinner, and more liquid, components of the gel would go up to the lymph nodes and it would cause inflammation."
South Australian independent Senator Nick Xenophon instigated last year's Senate inquiry, which found the TGA failed to monitor years of missing annual reports by the sole local distributor of the implants, Medical Vision Australia, which would have included information on complaints about the product.
"Even if they try to hide behind this veil, that the silicone is not toxic, which is contentious in itself, it [the TGA's handling of the scandal] raises the question that the TGA is involved in a massive backside-covering exercise," says Xenophon. "What they said was in the product wasn't, which shows a flaw in the regulatory process. It is a pathetic excuse for a watchdog."
Kerrie Tyler's soft, attractive face belies her recent, year-long struggle with chronic fatigue so debilitating that the daily routine of caring for her son, now 12, seemed insurmountable. ''I was taking so many painkillers," she says. "I was in bed and sleeping and having really hot baths because I was in so much pain and just crying, and trying not to cry in front of him.''
She suffered ''burning pain'' in her chest, which she blames on the amount of silicone later found floating around and clogging her lymph nodes - some of it still there.
The 46-year-old Sydney woman bought her PIP implants at a discounted rate of $4500 and never gave much thought to the brand - until they ruptured. ''I felt something was wrong because they were so lumpy and painful, and I was having a lot of night sweats and really bad migraines,'' says Tyler. She had her implants removed in 2011. Tyler also has unexplained fibromyalgia, making her joints and muscles ache from her feet to her neck. These days, she tries to manage the pain with nerve and migraine medication.
Despite all she's been through, Tyler has decided to go under the knife again for a breast-lift procedure, at a cost of $10,000. "I was very unhappy with their shape and how heavy they felt. They were also uneven after the implants were removed."
On the day of the operation, Tyler's plastic surgeon, Dr Eddy Dona, uses a marker and small ruler to deftly map out her torso and breasts, explaining how he will give her a ''perkier'' appearance, before she is wheeled into theatre at Norwest Private Hospital.
Dona applies the antiseptic, inserts a very long syringe to inject local anaesthetic under her breast, and uses a cookie-cutter-like metal circle to mark where he will slice around her areola. The anaesthetist's favourite dance music playing in the background is a welcome distraction from the confronting sight of her nipple being ''mobilised'' so that it can ultimately be moved up.
Dona spends an hour or so carefully dissecting her breast tissue while another surgeon assists, removing breast tissue with metal spatulas.
After surgery, Tyler, a beauty therapist, smiles softly when she hears all went to plan and her pain will subside over the next four to six weeks. The scars will take 18 months to fade. ''I haven't been able to work - just too tired and in too much pain. I don't want any more surgery."
A few weeks later, she says, "My breasts still look uneven. But they don't look as saggy and don't feel as heavy."
Tyler is one of hundreds of Australian women devastated at the collapse in March of a class action against Medical Vision Australia Pty Ltd, after it was discovered the company only had product liability insurance for three of the six years it sold the implants. Some 500 women have since joined an international class action against PIP's insurer, Allianz France.
In December 2011, on the same day that the French government urged women to have their PIP implants removed, Medical Vision Australia's owner, Zdenko ''Stan'' Racic, 57, registered a new company, Medical Vision Australia Holdings. He is one of seven distributors selling 46 different types of breast implants, although in April this year, liquidators Heard Phillips referred Medical Vision Australia Pty Ltd to the national financial regulator, the Australian Securities and Investments Commission, over ''possible misconduct in relation to the affairs of the company".
Almost all of the 1300 women who contacted the Adelaide-based law firm Tindall Gask Bentley in regard to the Australian class action had been adversely affected in some way, says partner Tim White. "Many experienced physical issues such as pain, swelling, lymph node damage, illness and infection. Almost all women spoke of the psychological toll, which ranged from stress and anxiety to depression," White says. "There's also the financial cost, where women who had already spent between $10,000 and $20,000 on the initial surgery were now trying to find thousands more to pay for urgent revision surgery."
Perth woman Tammy Reynolds, 34, had an eight-month battle to withdraw money from her government superannuation fund to cover the $12,000 needed to replace her PIP implants after an MRI scan in March 2012 revealed that both had ruptured so badly they had broken into pieces. She had the implants in 2004 because of an congenital abnormality known as tubular breasts, and decided to have an MRI scan after the publicity surrounding the PIP implants.
''My family was freaking out, saying, 'These are toxic, you are going to get sick,' '' says Reynolds.
After the surgery she was in extreme pain, and unable to dress herself properly or lift anything heavier than a loaf of bread for six weeks - especially tough when she had an 18-month-old baby boy. ''Nothing prepared me for the second [replacement] surgery - it was so much more invasive. Not only did they have to remove the destroyed implants, but they also removed all of my own breast tissue to make sure I had no trace of the implants left."
She has kept the implants in a bucket at the top of her wardrobe in the hope she will one day be able to seek some compensation, saying she has been "financially crippled from all of this. It has been a hell of a ride.''
The fallout from the PIP scandal is expected to continue for several years as testing and research continues and women seek redress. Last month, Sweden became the latest country urging women to have them removed as a precaution, after tests by its health authorities showed significantly high concentrations of a chemical irritant. The Senate inquiry, which the federal government is yet to respond to, concluded that the true rupture rate here is unknown and recommended that the TGA say so in its advice.
The TGA's national manager, Professor John Skerritt, says the rupture rate in Australia is ''slightly higher, but nothing like two times and six times higher ... All we know is that we have different batches of the same product and we may have just been lucky in Australia. I don't think the message is that these are safe, go away and forget about them. The message is, as with any implant, that you should monitor it."
The federal government has established a $12 million national breast implant registry, and in May announced the extension of its 12-month free MRI service to 2015.
''And four years jail [for Mas] and his life goes back to normal? God bless him. I wish I could have that guarantee."
