When the PIP scandal broke across the Rhine in 2010, few breast implant patients in Germany were informed they were carrying toxic time bombs manufactured by a bankrupt French company under criminal investigation. Up to 500,000 women in Europe alone are believed to have been affected – including many in Berlin. EXBERLINER found out what happened.
Maria woke up one morning in August last year and felt a stabbing pain in her left breast. Anxiously she started feeling her breast. She had had cancer a while ago. Both of her breasts had been removed and had been reconstructed with silicon implants. Now, she felt that the left breast had shrunk. Maria (whose name has been changed to protect her identity) started to panic, nervously running her fingers into her armpit. She felt hard, fat knots.
She went to Prof. Dr. Nektarios Sinis’ office the same day. Dr. Sinis is the head physician for plastic-, hand- and microsurgery at St. Marienkrankenhaus in the southwestern Berlin suburb of Lankwitz. He is a specialist. Dr. Sinis starts working where other doctor’s capacities end.
“Maria was an emergency,” Dr. Sinis recalls. He is a slender 37-year-old man with fine features, rimless glasses and a tired but content smile on his face. It’s 8pm and he has come straight out of the operating room where, for the past 12 hours, he transplanted skin from a young man’s thigh to his ankle. His office is the size of a broom closet; on his desk stands a tiny, sad looking plastic flower. Dr. Sinis doesn’t spend a lot of time in here.
He operated on Maria the day she came in. Her implants had burst. The silicon had flowed into her tissue, touching nerves and arteries. In a highly complex, five-hour operation Dr. Sinis took both implants out, microsurgically removed the knots, which resembled those found within cancer patients, rinsed the tissue clean and formed new breasts for Maria out of fat from her abdomen. The broken implants Dr. Sinis’ held in his hand after the operation had a label on the backside: “PIP”. “At that moment I knew right away: These implants are the cheapest of cheap,” Dr. Sinis says. “Junk.”
PIP is short for “Poly Implant Prothèse”, the name of a French manufacturer of silicon implants whose CEO, Jean-Claude Mas, was arrested in January, a bald man with a grey beard laughing grimly in his police mug shot. The prosecution in Marseille are investigating him for assault and negligent homicide.
In April 2010 France had already forbidden PIP to sell implants, since it had been discovered that these implants could rip easily (roughly one out of 14) and presumably cause cancer.
Shortly after Mas’ detention, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) or Federal Institute for Drugs and Medical Devices published a recommendation that women with PIP implants see a doctor and have them removed as quickly as possible. Apparently there was not only a chance of rupture, but also a high probability that the silicon could literally seep out of them.
While in France it’s been established that 30,000 women have PIP implants, the number in Germany remains unknown. What is known is that three practices and one hospital in Berlin used PIPs. Although some warnings were regularly voiced through the Federal Institute for Drugs and Medical Devices, the Berlin government didn’t react officially until the scandal erupted in the global media.
It wasn’t until December of last year that the health authorities finally informed Berlin practices and asked them to contact women who had received the implants – only 25 have been found so far.
So why were these cheap implants being used at all? “Competition is high amongst beauty doctors,” says Dr. Sinis. To a certain extent he can understand that some of his colleagues try to keep prices down by using cheap implants. But prices as low as €3999 (as could recently be found on the discount platform Groupon, offered for example by Medical Beauty Clinic Berlin near Ku’damm) – when the standard price for a breast augmentation lies between €5000 and €6000 – can only be possible if compromises in quality are being made.
Many women are willing to go for bargain implants because they don’t have enough money. For Dr. Sinis, it’s their responsibility to be prepared to not receive the highest quality, given that they should most certainly be informed by their doctor about what risk they are facing.
“But we are not only talking about some table dancer here who needs a perfect body for work,” says Dr. Sinis. “The real scandal is that the huge share of patients I treat are cancer survivors who received PIP implants, paid for by their health insurance, in university clinics. And no one informed them about what they were getting or about alternatives.”
Women like Maria, says Dr. Sinis, have run into this completely blind. At least once a month he has a woman on the operating table with PIP implants.
When Dr. Sinis’ job is done, Jörg Heynemann’s work begins. Heynemann is a lawyer specialising in medical law. He gets called when doctors mess up or the pharmaceutical industry sells dodgy medications and prostheses.
In the past months Heynemann, who has his office at a simple apartment building on Mitte’s Brunnenstraße, has taken on 90 new clients from all over Germany. All these patients are women who received PIP implants, a quarter of them after they had cancer, and Heynemann is now working long hours to find out who is going to compensate for the pain these women have gone through or still have to suffer.
“Normally we would sue the manufacturer, but since PIP is insolvent there is nothing to get there,” Heynemann says. He is now checking whether PIP’s insurance, Allianz France, can be held liable for financial compensation for victims – to cover the cost of removing the implants and damages for injury.
He is also checking if TÜV Rheinland might have to pay compensation. TÜV is the German Association for Technical Inspection, which certified PIP implants for Germany. Heynemann says the PIP scandal exposed the structural problems of monitoring medical products. TÜV doesn’t carry out the tests itself. The manufac- turer hires private institutes that claim to work independently but are paid by the manufacturer.
The process is highly questionable according to Heynemann. He doesn’t blame the doctors who quite rightly trusted a TÜV-certificated implant. Even for Heynemann, who has worked in the field of medical law for 10 years now and currently has 800 clients, PIP is an exceptional case. “500,000 women all over Europe,” Heynemann says, “that’s a lot.” But more to the point: “I’ve never seen a case where patients were deceived with so much criminal energy.”
PIP seems to have become the biggest scandal in the history of cosmetic surgery, even bigger then the first silicon scandal in the 1990s, when it first became known that implants can tear and that silicon entering the body can pose a danger to health.
Back then a group of women in Germany founded the Selbsthilfegruppe für Silikongeschädigte Frauen (SSF), or the Self-help Group for Silicon-Damaged Women. The support group had 1000 members in the mid-1990s, again, most of them former cancer patients. Their main focus was on getting compensation for victims. They found a way for German women to join American class action lawsuits against implant manufacturers, and a huge share of SSF’s members eventually got compensated, financially at least.
“The real damage is psychological,” says Walter Lutomski, SSF’s current chairman. He has seen his own wife suffer, first from physical pain when her implants cracked. Then he saw her shame, her feeling dumbstruck when it was clear that she had been living with a “time bomb inside her body”.
Since the 1990s the SSF has done a lot of educational work to publicise the dangers of silicon implants. They only have a couple of dozen members today, since many left the group after their successful lawsuits.
Now and again Lutomski gets a call from a woman who wants implants; then he talks, very soberly, about ruptures, about encapsulation (hardening of the tissue), and again about the pain. The dangers of silicon are well known today. PIP should not have been allowed to happen.
Today, no woman who wants to have her breasts reconstructed after cancer should receive implants, Dr. Sinis says. “Even where implants are inserted for cosmetic reasons, a reaction to a foreign object can appear after 10 or 15 years, and for cancer patients this can happen after only two or three years, because their tissue is already damaged from the tumour.”
The alternative promoted by Dr. Sinis is forming a new breast with fat tissue taken from the stomach. It’s a very complicated method few doctors can perform. At the moment in Berlin only St. Marienkrankenhaus, where Dr. Sinis and his team work, and a few others offer reconstruction by transferring fat.
Dr. Sinis’ patient Maria had to stay in St. Marienkrankenhaus for one week and it took another six weeks for her wounds to heal. After six months she should be back to her old shape again. And, Dr. Sinis says, thanks to the fat transfer, her breasts will never have to be operated on again.