This is a story that has to be told from the end. A mysterious bacterial organism appeared in the private Jacuzzi in the home of the plastic surgeon Dr. Michael Scheflan in the wealthy community of Savyon, near Tel Aviv. Scheflan was not aware of this. No one was aware of it. But 15 women, aged 18 to 70, became infected when they underwent breast surgery at Atidim Medigroup Hospital, in the Ramat Hahayal section of Tel Aviv. The operations were performed from July to November 2003. The surgeon in every case was Scheflan himself, the center's director and owner, who is considered one of the leading plastic surgeons in Israel.
Most of the women had come for cosmetic purposes - breast augmentation or breast lift - but four of them were breast-cancer patients who underwent mastectomies and reconstructive breast surgery. The most amazing detail in this story is this: a lengthy and thorough investigation undertaken by the Health Ministry to trace the source of the infection concluded with a finding that no one expected and that appears to be without precedent in the world medical literature: Dr. Scheflan himself was the carrier of the mycobacterium, as it is known. It was present in his hair and his eyebrows and he infected, unknowingly, the women he operated on.
Even though eight months have passed since the investigators and Scheflan himself learned these facts, and half a year since an official report on the case was completed, some of the affected women learned only in the past few weeks about the existence of the report. Dr. Galia Rahav, the director of the infectious diseases unit at Sheba Medical Center, Tel Hashomer, was appointed by the Health Minsutry to head the investigative commission that examined the case. Rahav describes an unfolding scenario that would not be out of place in a detective thriller. By a process of elimination, as they rejected more and more potential sources for the bacterial infection, a surprising line of inquiry emerged, which led the team to Dr. Scheflan's home, in Savyon.
"Samples were taken from the rest of the family, from the cleaning woman, from his two dogs, from the bedding, blankets, pillows, towels, tap water, shower, pool, Jacuzzi, washing items such as hair gel, shampoo, soaps and the electric shaver," the report states. Finally, the mystery was solved: "The mycobacterium smegmatis originated in the water of the Jacuzzi, in the wet towels that were used after emerging from the Jacuzzi, and from the pillow he used for his head after the Jacuzzi."
The report on which Rahav signed off was completed on March 22, 2004. It concludes on an optimistic note: "The source [the Jacuzzi] was cleaned and its disinfectant system repaired. The surgeon and the members of his household used effective material to eradicate mycobacteria, and, indeed, since the riddle was solved, Dr. Scheflan and his home are no longer carriers." However, for the women who were infected, the episode is not yet over: "We have here a phenomenon of 15 cases of infection in a surgical wound after operations on those involved using implants," Rahav wrote in the concluding section. "The infection is caused by an untypical mycobacterium that grows rapidly, which in effect we declared to be a new bacterium ... The implants were removed from all the women. Most of them underwent antibiotic treatment lasting from three weeks to three months. One of the women needed additional operations."
The bacterium that was discovered bears a distinct resemblance to another organism, whose scientific name is mycobacterium smegmatis wolinskyi, and as long as it is not confirmed as a new strain it will continue to bear that name; it is a distant relative of a known mycobacterium, which among other traits is a fomenter of tuberculosis in its carriers. A relative, because they are both from the smegmatis family; distant, because it is an unknown type. The bacterium entered the area that was operated on, attacked soft tissues along the surgical scars, generated repeated infections and caused excretions from the wounds. According to the small amount of information available about bacteria of this sort, it's probably there to stay.
Dr. Scheflan learned the appalling news that he himself was the carrier in January 18,
2004, about two months before the report was completed. His life became a nightmare. The lives of the 15 women had already turned hellish. Some of them had returned for various surgical treatments at his clinic (and thus were repeatedly exposed to the infectious source, in the form of the surgeon himself), until they arrived at the painful but unavoidable stage: surgery to remove the implants from their bodies. In some of the women the bacterium is still alive and kicking even now, months after the implant was removed. Infections appear from time to time on the surgical scars. The women have to undergo repeated treatment in which the stitches are opened, the area is surgically cleansed, the infected tissues are removed, and the wound is again stitched up. One of the women, Ayala Gal, underwent this treatment just a few weeks ago.
The future of the affected women is unclear. The expert on the subject, Dr. Rahav, says that there is no way of knowing what this bacterium is liable to foment in the future. It is unknown, its characteristics are unknown, there is no precedent for this case, and no substantive information exists that might be able to help cope with it.
The Health Ministry did not make the report public. Dr. Scheflan did not publish the findings or the fact that he is the carrier. The women who were infected did not receive any notification, either from Dr. Scheflan or from the Health Ministry, about what the commission found. One of the women relates that she asked Dr. Rahav for weeks, day after day, what the investigation had found, until in one of the conversations she heard from Rahav that a report existed. She demanded to see it and passed on the information to her friends - and only then did Ayala Gal find out that there was an official report.
From the outset, Dr. Scheflan was in no hurry to report to the Health Ministry about the complications affecting patients he had operated on. It was not until October 26, 2003, that he informed the ministry about 10 cases of infection in women he operated on from July to September. He asked for the ministry's help in locating the source of the infection. According to the ministry's standard procedure, "Any increase in the number of cases of post-surgical infection in two or more patients must be reported." The Health Ministry, its spokesman stated at the time, "takes a grave view of the tardiness of the report about the events and will consider taking steps. A timely report would have made possible an early investigation of the infections and prevented additional cases."
The steps that were taken, it turns out, amounted to a cosmetic change in the conditions of the clinic's license. According to the Health Ministry, "an explicit demand was added [to the terms of the license] for the director of the center to report every unusual event, beyond the regular reporting obligation." In addition, at the ministry's directive, breast surgery at Atidim Medigroup Hospital was suspended for nine days (November 1-9, 2003), until the source of the infection could be located, and a team of experts was sent to examine the working conditions at the center. Flaws were discovered in the water system, the ventilation system and in work procedures. The source of the infection was not found during the nine-day period. The Health Ministry received a report about repairs and improvements that Dr. Scheflan had made and allowed him to resume the surgical treatments.
Concealment of information
People who contacted the center during this period were told that the problem had been solved and that there was no cause for concern. However, when infections were discovered in more women who underwent surgery at Atidim, the Health Ministry set up the investigative commission headed by Dr. Rahav. The commission's report shows how thoroughly it went about its work: "About 300 mycobacterial samples were taken from structures, equipment, surgeons and from various staff; from the operating theaters (operating table, window, bed, lamp, surgical equipment), from anesthetic equipment, swabs, from the implants - before and after the surgery ... From the treatment staff (doctors, nurses, auxiliary personnel) samples were taken from nose, scalp, face, hands, underarms and eyebrows." The bottom line: "The mycobacterium smegmatis that was isolated from the surgical wounds of the female patients grew in the hair and eyebrows of Dr. Scheflan."
Dr. Scheflan and the Health Ministry kept that information to themselves. When Scheflan found out (in January 2004) that he himself was the carrier and the source of the infections, he did not share the information with his patients. The Health Ministry ordered him to stop operating. After he underwent treatment against the bacterium and washed himself a number of times using a special antibacterial soap, and after samples taken from his body showed that the bacterium had disappeared, Scheflan resumed his regular surgical activity, with the authorization of the Health Ministry.
The women who were infected feel that they were abandoned to their fate. Even Dr. Rahav, their last hope, says she has no more information about the bacterium, that they should not even consider additional surgery and that they should focus on strengthening their immune system and on recovery.
Ayala Gal, 44, one of the 15 infected women, works as a surgical nurse at Ha'emek Hospital in Afula. In the living room of her home in Kibbutz Beit Hashita, she goes over the report for the hundredth time but still finds it difficult to digest what she reads. The casualties of the Atidim center are divided into two groups: 11 healthy women who underwent surgery for breast augmentation or breast lift (some of them are now consulting with lawyers about the possibility of suing Dr. Scheflan and the Health Ministry, and did not wish to be identified by name at this stage); and four women who are cancer patients and came to the clinic for a mastectomy plus "immediate reconstruction," or had already undergone mastectomy and wanted to create a new breast for themselves.
The cancer patients found themselves in a nightmarish situation. Even as they were waging a bitter fight for their lives and coping with the terrors of the disease, with the side effects of chemotherapy and with fears of the recurrence of the cancer, they were infected by a satanic bacterium. And what brought this about? Reconstructive surgery, which for them was a ray of light in the dark. The story of Ayala Gal is the story of these women.
Stars in her eyes
Ayala Gal, a big, strong woman, says that when she was diagnosed with cancer she resolved to remain alive. The lump was discovered in the course of a routine mammography. As a woman in the medical profession, she was not entirely surprised. Her two aunts - her mother's sisters - had died of cancer at relatively young ages, so she was in a risk group. Still, "as a woman, as a person, my world collapsed on my head." After giving birth to her first son she underwent years of hormonal and fertility treatments before giving birth to her two other sons. She was treated with Pergonal, a hormonal medication to induce fertility which is itself problematic. Gal was aware of that. "But I took the risk, because I wanted very much to have children," she said.
As a senior nurse, she received all the information about her disease immediately and understood well the seriousness of her condition and what she could expect. In addition to having a mastectomy of the diseased breast, she insisted that the physicians remove her healthy breast, too, as a preventive measure. "The continuation of the plan was to remove the ovaries, which I knew was unavoidable."
The growth in her breast was quite large. In the first stage she underwent lumpectomy, an operation to remove the lump and lymph glands. Then came a series of chemotherapy treatments: "For half a year I lived in the bathroom, most of the time sprawled on the floor, throwing up." For most of her life ("until not long ago") she was a good-looking woman with a shapely body, and she never imagined, she says, that at the age of 43 she would have no breasts. "I told myself two things: one, I am staying alive, and two, I will come out of this beautiful and aesthetic."
She did a search to discover the most highly recommended surgeon and plastic surgeon for a mastectomy and a reconstruction. The answer, she says, was unequivocal, from colleagues at the hospital, from girlfriends and from her private insurance company: the surgeon Prof. Moshe Papa and the plastic surgeon Dr. Michael Scheflan. With no hesitation she chose them both and decided to have the operations done privately.
Two and a half weeks after she had been diagnosed with cancer, even before the first chemotherapy treatment, she saw Dr. Scheflan at the Atidim center in the Ramat Hahayal neighborhood of Tel Aviv. "He was very nice to me," she recalls. "He treated me as a colleague, not as someone who shows up with no idea about what to expect. He respected my knowledge, my experience. It was as though we became a team that would deal with the problem together. He was both sociable and professional, and that charmed me. He showed me before-and-after computer images. Beautiful breasts, perfect, of course, my life's dream." (Dr. Scheflan, in response: "I never show images of perfect breasts. I show a picture of average results. Not perfect.")
Gal: "He said the mastectomy would be performed by Prof. Papa, with whom he worked regularly and who is the best there is. And as soon as I completed the chemo, and my blood count was normal, he would be delighted to `arrange' the chest. He led me to understand that when I left the operating table I would have two beautiful, erect breasts. I breastfed each of my children until the age of one, so that my breasts weren't in such great shape. It sounded very rosy. I came to him a frightened woman, whose world had collapsed, and I left his clinic encouraged and, I would even say, rather absurdly, happy."
It sounds as though the cancer had become a secondary issue.
"That's exactly it. The cancer became something marginal. The main thing was the beautiful new breasts. On the way there was some surgical procedure of amputation - no big deal."
But you are a surgical nurse. You have seen cancer patients. You treated cancer patients. You have access to every bit of information you might want. You can't say `I didn't know,' can you?
"That's right. I have no rational explanation for what happened to me. I was in a movie. The desire to get well and the fantasy of waking up from the operation as a new, beautiful, desirable woman took control of me."
Did Dr. Scheflan say anything to you about complications, failure, implant rejection?
"He said, `In the world at large, the known failure rate is 3 to 5 percent, and you undoubtedly understand that that is a minuscule percentage.' In the world, not with him. I knew that this was a doctor who had performed hundreds or thousands of breast reconstructions for women in Israel. I trusted him 100 percent." (Dr. Scheflan: "Ayala heard the exact statistical data from me, and agreed knowingly to sign a document in which everything is set forth.")
Nevertheless, the nurse within her voiced a faint doubt. She went to Dr. Haim Kaplan, at Sheba Medical Center, for a second opinion. Kaplan, she says, was "drier." He reviewed the state of her sickness, suggested that she first concentrate on chemotherapy and recovery, and only then start thinking about reconstruction. "The feeling with him was heavy, hard, not encouraging," Gal says. "With Scheflan the feeling was that he would take the stars down from the skies for me. I chose the stars."
With eyes shut
After recovering somewhat from the chemotherapy treatments, Gal met with Prof. Moshe Papa at his clinic in Assouta Medical Center in Tel Aviv. In retrospect, she says, the conversation with him was hallucinatory. Again the cancer was shunted aside, as though a mastectomy were a triviality. And this time it was a senior surgeon, not a plastic surgeon. "The feeling he gave me was that everything was clear-cut. You cut and you reconstruct. One destroys, the other builds. He prepares the infrastructure for Scheflan. Scheflan, the artist, makes me wonderful breasts." (Prof. Papa in response: "Medical confidentiality precludes my commenting on this point.")
They set a date for surgery at Atidim, on November 11, 2003. And again she felt doubts. The nurse in her suddenly wondered how it could be that she would undergo a double mastectomy plus reconstruction and implant at a clinic that was a "center for intermediate surgical medicine" which enables only 24-hour hospitalization. As a nurse, she knew that the usual period of hospitalization for surgery is five days at least. But she silenced that voice, too. "I was fixated. I wanted this surgery, to be performed by these surgeons, and that overcame everything." (Dr. Scheflan in response: "In the United States the usual practice today is to discharge a woman a day after a mastectomy. The leading approach today is the shortest possible hospitalization, and that is proving itself. A short hospitalization prevents the possibility of contracting a disease and infection.")
Gal received one last warning sign. Two days before the surgery she had a call from a friend who was very upset. "Look at the papers," she told Gal. "There's a report about an outbreak of infection in breast operations in the clinic of Michael Scheflan at Atidim." Gal read the report and took fright. When she called the center, she says, one of the secretaries told her, "Don't worry, everything is fine. There was some sort of contamination here, in the water pipes of the building. It was checked and repaired. We received authorization to operate from the Health Ministry." (Dr. Scheflan in response: "Ayala did not come to me with questions. She made do with the reply she received from the secretary. If she had contacted me, she would have received a broader picture.")
Reminder: November 9 was the final day of the nine-day period during which the clinic was closed by order of the Health Ministry for disinfection and repair of the water and ventilation systems. Ayala Gal's operation took place only two days after the center resumed breast surgery, though the source of the infections had not yet been identified. Scheflan's clinic sent a message of business as usual. It's true that it wasn't known then that he himself was the carrier of the bacterium, but the flaws and defects that had been discovered by the Health Ministry 10 days before Gal's surgery were certainly known. (Dr. Scheflan: "No flaws were discovered. My attention was drawn to certain things, and of my own volition I did upgrading and improvement above and beyond, at a cost to myself of about a million shekels. I installed a disinfectant and sterilization system that has no peer in Israel today.")
Gal was preoccupied with her disease and her operation. She did not look deeply into the report in the paper. "I trusted Dr. Scheflan with eyes shut," she says. And that's also how she went into the operation.
Another victim of the mycobacterial infection uses the identical words to describe her experience. She is 30, the mother of two small children. "You have to understand, this is the great Dr. Scheflan. The famous doctor. The breast artist. I followed him with eyes shut. Who am I to suspect anything? To think that something bad could happen to me there? He gives you the feeling that you are in the best hands in the world. Other plastic surgeons I went to before going to him were actually more reserved. They told me not to fall into the illusion that I was going to be a top model after the operation. I was swept into it because of a powerful desire, a dream I'd had for years that I would finally have breasts I could be proud of."
Suspicion of bacterial infection
On the day after the operation, Ayala Gal awoke "weak, hurting, but optimistic." Within 24 hours of the surgery she was sent home." Prof. Papa didn't come to see me even once. Since that day I have neither seen nor heard from him. I went home with drain bulbs hooked up to the surgical wounds. Tremendous amounts of fluids were excreted through the drains. From almost the very first minute I knew that something was wrong." (Prof. Papa: "I agree with the approach, which is today customary throughout the world, which holds that the earliest possible discharge from hospitalization is preferable. Due to medical confidentiality, I cannot provide personal information. Every patient I operate on is invited to get answers and for follow-up. If a patient prefers to have follow-up by another doctor, that is of course her right.")
A few days after the operation, Gal removed the bandages. "When I saw the `breasts' I felt ill: two large, ugly protrusions, gross scars, which looked very bad. I am a nurse and I know what it's supposed to look like. Not like that. The color and the texture were not normal. A terrible disappointment. Everything hurt. I developed a fever and I felt awful."
The report of the investigative commission quotes Dr. Scheflan as saying that all the patients are closely monitored by the center's physicians. "Scheflan didn't call at his initiative even once to take an interest," Gal says. "I called to report to him on the situation. He said I should come to see him. Now began a series of trips between Beit Hashita and Atidim, with me in pain and unhealthy, every time for `corrections and improvements,' opening, closing, and opening again, replacing drains, removing drains, drawing fluids from the breast, treating the scar. The whole time I was on strong antibiotics. With fever and pains, getting progressively weaker. It felt as though I was wearing a wide elastic bandage, with tremendous pressure around my chest."
On November 20, a culture was taken from Ayala Gal's drain, and it was replaced. On November 23 she underwent another operation, in which the areas that had become infected were removed and an attempt was made to restore everything. On December 1 the laboratory sent back the results, which indicated "suspicion of bacterial infection." The mycobacterium has not been eradicated. The hypothesis of the Health Ministry team that the source of the infection was the tap water collapsed thunderously. An investigative commission was appointed.
Dr. Scheflan employed Dr. Galia Rahav as his private consultant to investigate the case. ("He contacted me and asked me to come and advise him," Rahav says. "I did so. I have not yet been paid by him, neither I nor the two senior nurses I took with me for the project. I am certain that when the reverberations of the affair have faded and he goes back to his routine, he will remunerate me. At the moment I have no complaints to him in that connection.") Now the Health Ministry appointed her to head a commission, whose other members were Mira Blich, a senior nurse who is in charge of preventing infection at Sheba Medical Center, and Yaira Guttman, the chief surgical nurse at Assaf Harofeh Hospital.
In pain and disappointed, Gal oscillated between hope and despair. Scheflan's attitude, she says, confused her: "On the one hand, he continued to speak to me sociably, on the basis of our supposed collegial status. His attitude was that this was a technical hitch that would instantly be corrected and that would be that. On the other hand, to this day he has not actually sat across from me even once and said, This is the situation, this is what happened, I'm sorry. He did not take responsibility. He did not offer support, a refund, compensation, nothing." (Dr. Scheflan in response: "In the period when everything was known I offered all the women in question, including Ayala Gal, a refund of the cost of the operation." Ayala Gal in response: "There was no such thing. He never raised the money question. When I came for the first correction, I even paid the anesthetist another thousand shekels.")
The 30-year-old victim feels the same way: "As the director of the place and as the physician responsible for me, it was my impression that he was not assuming responsibility. When I came for corrective surgery he had the chutzpah to take another NIS 2,700 from me for an operating theater and an anesthetist. When I told him about my frustrations afterward, he offered to refund the cost of the operation, NIS 45,000. But when we came to get the money he demanded that I sign a waiver of any future claim. Of course I refused and we left the place immediately." (Dr. Scheflan in response: "My reputation and my good name as a senior physician who is reliable and responsible will not be made and will not be tainted by Ayala Gal or any other specific surgical patient. I have performed thousands of breast operations in Israel and abroad. I took responsibility in the full sense of the word. There is no basis for those comments and I find it hard to believe that they really said that to you. They say different things to me.")
On December 10 Ayala Gal underwent a second corrective operation. Scheflan told her that he was consulting with Dr. Galia Rahav about her case. "I didn't know about an infection identical to mine which had been contracted by other women who were operated on at the clinic, nor about an investigation or about samples being collected at the center," says Gal. On December 21 she heard for the first time that a mycobacterium of a new strain had been identified in her body, one that behaved differently from the known mycobacterium. She demanded more information from Scheflan and Rahav, and heard, to her horror, that this was a bacterium that becomes active in the presence of a foreign body, engenders repeated inflammations, and that recovery from it is impossible as long as the implant remains in the body. At first it was thought that it could be eliminated by treatment involving several types of antibiotics, but it turned out that the bacterium was stronger than the treatment. That same day one of the two implants was removed from Gal's body.
Gal: "My world was in ruins. Scheflan said something like, `Regrettably, you have become part of the statistics. Your case is a singular one, your body did not react well. You fell into the 5 percent that reject the implant.' No more than that. The 30-year-old patient-victim says she heard the very same words from Scheflan: "Regrettably, this has happened. Your body did not react well. Your case is a singular one. With you it's especially turbulent. There's nothing to be done, you have become part of the statistics."
Even before Gal knew the true facts, something within her was outraged to hear these remarks. She returned home in a state of agitation. "I went to the Internet and entered all the forums on the subject. I described my case. I left an address and asked for information and help. In short order I got a reply from a woman who said she had breast augmentation surgery done at Scheflan's clinic at Atidim four months earlier, and had also contracted the mycobacterium. She told me that the Health Ministry had been investigating the matter for a long time, under Galia Rahav. She said they knew there was a bacterium there and that they had concealed all the information from us. There are no words to describe what I felt at that moment. None."
Once the information started to flow, it never let up. Gal made contact with another woman who underwent surgery at Atidim. From her she learned that 15 women were affected, that they already had a name - the "Atidim casualties" - and that some of them were in touch with lawyers and were considering lawsuits. After getting in touch with two more women, Gal is very angry at Scheflan: "We, as human beings who were harmed, just don't interest him. He told each of them that she was a special case, singular. He tried to pass on the responsibility to us, as though our bodies caused the problem, not his bacterium. He may be a good plastic surgeon. At the human, moral and responsible level he failed big-time. I don't want to see that person again."
Dr. Scheflan in response: "Most of the women are in contact with me. They are not contemplating a lawsuit, they know I very much regret what happened, and they continue to place their confidence in me. I wish to thank them for their demonstration of faith and for the privilege I have been given to go on being their physician, both in the period of the crisis and after the problem was resolved."
Dr. Galia Rahav uses similar language: "The problem was resolved. The affair is over. The problem was eradicated." Gal and the younger woman seethe with anger when they hear this. "Resolved? Ended? For who?"
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