US: 2006 FDA imprimatur on breast implants & misleading advertising exposes women to expensive risks Print E-mail

Feminist Research in a medical world refusing to take women's complaints seriously

Dumble, Lynette J. Silence falls on silicone victims. The Canberra Times, December 12, 1994, page 11.(Scroll down to read in full)

Dumble, Lynette J. The scandal of silicone implants. Green Left Weekly [Issue 214]. December 5, 1995.(Scroll down to read in full)

Dumble, Lynette J. Dismissing the evidence: The medical response to women with silicone implant-related disorders. Health Care for Women International 1996: 17: 515-525.

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 December 12, 1994, page 11

Silence falls on silicone victims

By Lynette J. Dumble

Silicone, a supposedly inert viscous substance, has been used  in  the breast reconstructive surgery of  more than 3 million women worldwide since 1962. Claims disputing silicone's safety have finally reached the ears of the federal regulatory body in the United States, the FDA, which after hearing evidence that silicone  was responsible for the alarmingly frequent incidence of auto-immune connective tissue disease amongst women with breast implants, and a much smaller number of men with penile and testicular implants,  placed a moratorium on its use. The future of silicone implants now rests heavily on the outcome of belatedly commenced follow-up studies and drawn out legal battles, both of which promise cold comfort  to 150, 000 Australian women with silicone breast implants.

This is not the first time that health consumers, the majority of whom are women, have been placed in jeopardy by a medically prescribed programme. Just six months ago, an Independent Inquiry returned a damning indictment of the medical profession's role in  the Human Pituitary Hormone Program  that  left at least 2,300 Australians at risk of a cruel and invariably fatal brain illness known as CJD or Creutzfeldt-Jakob disease. Health Minister Carmen Lawrence responded by establishing a $10 million Human Pituitary Hormones Trust Account that, in effect, assures the victims of  this  iatrogenic [doctor-induced] disaster  that their claims have finally been taken seriously.

Silicone was in fact used to manufacture insecticides in the 1950s. That information may have been the closely kept secret of chemical companies with putrid ethics, but let's not fool ourselves, medical literature to debunk the myth that silicone was inert has been around  for more than two decades. Countless articles  published mainly in specialised surgical journals, warned  that silicone implants undergo changes after contact with body tissues, and leak silicone into the surrounding tissue. Animal studies demonstrated that silicone promoted inflammatory and fibrous tissue reactions, and that large amounts of free silicone migrated throughout the entire body. The animal studies, unexplainably and irresponsibly, were never extended to investigate the long-term consequences of silicone migration following an implant leakage or rupture, nor was there any research in appropriate animals to figure out the relationship between silicone and auto-immune disease. Clinical results, from over 20  years ago,  indicated that a silicone bleed or leak from an implant could provoke a still greater inflammatory response because it was probably the physiological equivalent of a silicone injection. That message went unheeded, despite FDA withdrawal in 1976 of  the  licence for liquid silicon injections, an action that should have pre-empted an end to silicone implants.

Experts predict that 20% of women with silicone breast implants will develop mild, moderate or severe symptoms of  toxicity, and already more than  4000 Australian women have registered serious silicone-related illnesses with consumer organisations. A 1993 medical review of the history, complications and safety of silicone breast implants noted that, given the large number of women with silicone implants and rheumatic disease, especially scleroderma,  epidemiological studies were warranted.Yet, for one reason or another, the devastating effects of  silicone-related diseases not only on women's lives, but also on the lives of those who love them, has failed to prompt the outrage and sympathy deserved. Their situation, more often than not, adversely affects their personal relationships, and many [barely aged 50], unable to physically or psychologically tend for themselves, are permanently nursed in homes for the aged or the mentally ill. Some are confined to life in a wheelchair. They and others need around-the-clock supervision to prevent self injury because they have been robbed of  their manual dexterity. Many endure constant pain, due in part to their silicone-related illness, but frequently worsened by botched attempts to surgically correct technical problems with their implants. The women's personal efforts to overcome low self-esteem are thwarted, not only  by  mirror images of their scarred and mutilated breasts, but also by the medical uncertainty that surrounds their atypical illnesses.

Even though silicone implant recipients deserve the same acknowledgment as those injected with human pituitary hormones, their plight is ignored or contradicted at every level. Socially, their support comes almost entirely from self-funded consumer groups that operate with precious little outside financial assistance and are grossly underwomanned to keep up with demands. Legally, US justice has manoeuvred  them out of their chance for any worthwhile financial compensation, ruling that only 3% of  the chemical company's grid  be set aside for foreign claimants. But their worst and most disempowering rebuff comes from the medical profession itself; plastic surgeons who neglected to investigate whether the tools of  their trade were as safe as they led their patients to believe, and who now dismiss the claim that the women's problems are silicone-related

Eminent surgical identities have anchored the silicone experience in much the same manner as distinguished obstetricians, gynaecologists, paediatricians, and endocrinologists from the most prestigious of our universities and teaching hospitals underpinned the CJD affair. Dr. Lawrence's criticism and promised overhaul of prevailing medical ethics, both on announcement of the verdict of the Independent Inquiry, and  when introducing  the CJD Trust , should have sent shock waves through certain medical quarters, not the least of all that occupied by plastic surgeons. Gauged by the deafening silence, the Health Minister's  message seems to have dumbfounded  the usually outspoken presidents of the Australian Medical Association, and the respective Colleges of  Surgeons , Physicians, and Obstetricians and Gynaecologists. Or, is this silence a sign that those within the medical profession, whose ethics are unquestionable, welcome government intervention to straighten out the dubious ethics of its ruthless minority?

Public perception of  doctors has changed. It is now steeped  in distrust rather than past held faith. The medical profession needs to decide whether it can afford not to come clean and take responsibility for Australia's second group of iatrogenic victims. This means that the complaints of women with silicone implants must be taken seriously; studies immediately commenced to determine whether existing implants should be removed, replaced or left undisturbed; sensitive clinical and laboratory methods developed to detect silicone toxicity in its earliest stages; and relevant specialists co-ordinated to render appropriate treatment to cure, or at least alleviate, the debilitating illnesses that characterise silicone toxicity. Already some specialists, specifically from the University of Melbourne, have expressed a willingness to be involved in  an overdue centre for silicone victims that would also meet the needs of others suffering from delayed chemical toxicity as a result of environmental and industrial poisoning and remote reactions to prescription drugs. The medical profession's alternative is, as with the CJD affair, to dump the onus for its debt to society in  the lap of the federal government's department of health. That would win few or no friends, and would justify presently-voiced whispers to loudly shout that "Doctors make women sick" .
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Dr. Lynette J. Dumble is the Senior Research Fellow at the University of Melbourne’s Department of Surgery at the Royal Melbourne Hospital, Parkville, Vic., 3050, AUSTRALIA.

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 Tuesday, December 5, 1995

The scandal of silicone implants

By Dr Lynette Dumble

Based on proclamations of silicone innocence, ruling medical opinion continues to dismiss claims from implant recipients, the overwhelming majority of whom are women, that their serious illnesses are connected to their reconstructive surgery.

Evidence in three landmark settlements ­ US$4.2 billion against the implant manufacturing companies Dow Corning, Bristol-Myers Squibb and Baxter International in the US in 1994; another US$6 million in 1995 to an Alabama woman who developed potentially cancerous lumps and immune damage from rupturing breast implants that spread silicone throughout her body; and Bristol-Myers Squibb's out of court Can$28 million reserve for Ontario and Québec women suffering any implant-attributed disease as a result of implants supplied by its subsidiary Medical Engineering Incorporated ­ has uncovered the scandalous history behind implant surgery.

Added to accruing medical evidence of silicone's toxicity, the information revealed during the course of these legal proceedings suggests that medical dismissal is part of a larger conspiracy to conceal another chapter of medical misogyny.

Toxic
Despite the fact that silicone has been used in the breast reconstructive surgery of an estimated three million women worldwide since 1962, the substance has a long and dubious history that goes back to its use as an insecticide in the 1950s.

A decade later, when the window of opportunity for man-made breasts emerged, scheduled silicone toxicology was pushed aside as the manufacturers and surgeons focussed their attention on a mega-million dollar market. It is less than naive to assume that the silicone hazards were closely kept secrets known only to chemical companies with putrid ethics.

Evidence debunking the myth that silicone was inert has been around in medical literature for more than 30 years. Countless articles within specialist journals of plastic and reconstructive surgery warned that silicone implants underwent alarming changes after contact with body tissues, and often leaked or bled silicone into surrounding tissues.

Animal studies demonstrated that silicone promoted inflammatory and fibrous tissue reactions, and that large amounts of escaping silicone migrated throughout the body. Imprudently, the studies were never extended to establish the long-term consequences of silicone migration, nor was there any research in appropriate animal species to figure out the relationship between silicone and auto-immune disease.

Clinical results indicated that a silicone bleed provoked an even more severe and extensive inflammatory response, and was probably the physiological equivalent of a silicone injection.

Although the licence to inject liquid silicone was withdrawn by the US Food and Drugs Administration (FDA) in 1976, it appears that message was too subtle for manufacturers and surgeons to grasp.

Alternatively, the financial incentive together with a surgeon's perspective that implant surgery was the solution to women's demeaned body-image, overshadowed the welfare of a vulnerable group of health consumers.

It took until 1994, after hearing further evidence that silicone was responsible for an escalating incidence of auto-immune/connective tissue disease amongst women with breast implants, and a much smaller number of men with penile and testicular implants, for the FDA to finally place a moratorium on its use in reconstructive surgery.

Medical smokescreen
Memoranda, bearing an instruction to disregard after reading, warned the implant industry of immune dysfunction from silicone, but concealed the information from authorities until the renewed FDA consultations of 1994. Shamelessly, an editorial in the New England Journal of Medicine instantly argued that the FDA had been "paternalistic and unnecessarily alarmist" in banning silicone implants.

An editorial from the Lancet took an opposite stance, pointing out that the dismissive viewpoint of the New England Journal was largely based on a study from the Mayo Clinic, which was "insufficiently powerful" to detect an increased risk of connective tissue disease. In fact, the Mayo Clinic study was virtually irrelevant to women with breast implants since only asymptomatic implant recipients were interviewed.

Experts predict that 20% of women with silicone breast implants will develop mild, moderate or severe symptoms of toxicity, and more than 4000 women in Australia alone have registered silicone-related illnesses with consumer organisations.

A 1993 medical review of the history and complications of silicone breast implants noted that, given the large number of women with silicone implants, epidemiological studies were warranted. Yet epidemiology, which frequently amounts to decades of follow-up in sizeable populations, is neither appropriate nor essential to establish that silicone is the culprit. Epidemiology can be useful in risk assessment, but three decades of silicone implant case reports and population studies have already fulfilled the benchmark logic and criteria of disease causation.

Largely due to the medical smokescreen, the devastating effects of silicone-related diseases on women's lives have failed to prompt the outrage warranted. More often than not, their personal relationships are adversely affected and many [barely aged 50], unable to fend for themselves, are permanently nursed in homes for the aged or the mentally ill. Some are confined to life in a wheelchair.

Many require around the clock supervision to prevent self-injury because they have been robbed of their manual dexterity. Many endure constant pain, due in part to their silicone-related illness, but frequently worsened by botched attempts to surgically correct technical problems with their implants.

Women's personal efforts to overcome low self-esteem are thwarted, not only by mirror images of their scarred and mutilated breasts, but also by medical dismissal that their atypical illness has anything to do with their implant, or more patronisingly, is a figment of their imagination. Drawn-out legal battles and research by a "handful" of rheumatologists and immunologists promise cold comfort for the large number of women who endure serious illness after implant surgery.

The frequency and severity of implant-related illness is set to be grossly underestimated as cases inevitably escape the networks of an alert "handful", yet Dow Corning has already filed for bankruptcy protection in response to the volume of private claims made after the settlement awarded against them in the US.

Other effects
Based on "severely flawed" studies from prestigious institutions such as Harvard and the Mayo Clinic, the conspiracy to dismiss implant-related illness entices more and more women, and some men, to flirt with death for the perceived benefits of implant cosmetics.

At the same time, other vital issues such as whether breast feeding mothers with implants transmit silicone and its toxic effects onto their children, have been largely ignored. Similarly, although the possibility of silicone-induced breast cancer is denied by some studies, there is clear clinical and experimental evidence that it has the capacity to act as a carcinogen, raising the question of whether an increase in the overall cancer rate may result.

And lastly, given that the early detection of recurrent malignancy is critical to the survival of women who have previously undergone surgery for a primary breast cancer, the mere fact that silicone implants conceal the mammography detection of recurrent tumours in 40% of women gives an insight into the motives and preferences of certain medical prescribers when it comes to the welfare of health consumers who also happen to be women.

Owed the truth
Past experiences indicate that women have good reason both to shout foul and protest that their safety ran a poor second to the ambition and/or financial incentives of medical prospectors. Silicone implant recipients are due the same acknowledgment as victims of any iatrogenic disaster. At present, their plight is ignored or dismissed. Socially, their support comes almost entirely from self-funded consumer groups that operate with little outside financial assistance to meet the spiralling demands.

Women with silicone implants are owed a medical admission that the debilitating illnesses prevalent amongst implant recipients are the direct result of reconstructive surgery that was falsely promoted to be safe.

Studies are urgently required to: establish whether existing implants should be removed, replaced or left undisturbed; develop sensitive clinical and laboratory methods that detect silicone toxicity in its earliest stages; and investigate the advantages and disadvantages of detoxification procedures that could prevent terminal illness as a result of silicone toxicity.

While many within the medical profession are busily dismissing or dodging their responsibilities to silicone recipients, and manufacturers are fudging bankruptcy declarations, women and perhaps some men, are dying marginalised and uncompensated. Others are placed in further jeopardy because appropriate management, including silicone detoxification, is not forthcoming.

More still are inheriting the same risks as they, too, dice with implant surgery that is professed to be safe.
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[Dr Lynette Dumble is a senior research fellow at the University of Melbourne's Department of Surgery and a member of FINRAGE, Australia.]

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Thursday January 17, 2008

Skin Deep

Do My Breast Implants Have a Warranty?

By NATASHA SINGER

BE PREPARED Dr. Edward Melmed, in a scene from “Absolutely Safe,” removes an older-model silicone implant that failed (Amaranth Productions)

Read HERE the Synopsis and glowing reviews of Carol Ciancutti-Leyva's feminist acclaimed cinema on the subject "Absolutely Safe"

  NOTHING LASTS FOREVER A patient in the anti-implant documentary film “Absolutely Safe.” (Amaranth Productions)

A NAKED woman, her left arm strategically draped over her nipples, grins beatifically at readers in an advertisement for cosmetic surgery that equates breast implants with a more durable commodity: jewels.
   
“You know that feeling when you find the perfect size,” reads the copy for the Natrelle Breast Enhancement Collection that ran in the November issue of Elle magazine. “And we’re not talking diamonds.”

It is the kind of marketing analogy that gives breast implants a bad name. Diamonds, as De Beers and a James Bond novel once suggested, are meant to last forever. But breast implants often do not.

“Breast implants are not lifetime devices, and breast implantation is not necessarily a one-time surgery,” reads a warning in much smaller type on the back of the advertisement. Indeed, whether women initially underwent implant surgery for cosmetic reasons or for reconstruction after breast cancer, roughly one third of patients in clinical trials had a second operation within four to five years, according to statistical tables in the ad.

Almost two decades after a national hue and cry arose after fears that leaking silicone breast implants might cause systemic disease, breast augmentation has become the country’s most popular cosmetic operation. The renaissance of breast enhancement surgery is fueled in part by the Food and Drug Administration’s decision in 2006 to approve a new generation of silicone implants, ending a 14-year moratorium on their general use.

But with such high rates of reoperation, a new debate is emerging over whether breast implants constitute the kind of annuity medicine that will entail regular surgical tuneups, exposing patients to increased medical risk and out-of-pocket expenses. At a time when manufacturers have provided the F.D.A. with clinical studies that follow patients for just a few years, there is no established medical consensus on how long implants last, leaving doctors to rely on their anecdotal experiences when discussing durability with patients.

Given the lack of such data, critics said, women may not be prepared in the long term for the ordeal or financial burden of subsequent surgery.

“Your implants may last less than 10 years or more than 10 years, but when you start having problems with them, your health insurance is unlikely to cover the M.R.I. tests or the reoperations,” said Carol Ciancutti-Leyva, the director of a 2007 anti-implant documentary called “Absolutely Safe.” “It can be a very expensive proposition, especially if you are young.”

Many women are aware that implants can break down over time, requiring replacement just like car tires. Both saline implants, made out of a saltwater solution, and silicone implants, made out of gelatinous silicone, can form minute tears in their rubbery shells, causing ruptures. In the case of such defects that require product replacement, both manufacturers, Allergan Inc. and the Mentor Corporation, offer guarantees. Mentor has a 10-year guarantee to replace implants and defray some surgical fees; Allergan’s warranty includes lifetime implant replacement and up to $1,200 for fees for the first 10 years.

Dr. Mark L. Jewell, a plastic surgeon in Eugene, Ore., who is a past president of the American Society for Aesthetic Plastic Surgery, said he warns his patients that breast augmentation surgery automatically guarantees a second operation at some future date. He added that many patients in clinical studies had elected to have follow-up operations to change implant type, size or position.

“Women are used to having their hair or nails done on a regular basis to maintain their appearance,” said Dr. Jewell, who has conducted clinical trials for both implant manufacturers and is a consultant for Allergan, the manufacturer behind the ads running in Elle. “Ultimately, breast implants may also be a matter of maintenance.”

But a rupture is only one of the local complications that may engender additional surgery. Like cocoons that grow around larvae, scar tissue can form around implants; and sometimes that scar capsule hardens and squeezes the implant, causing pain and deforming breasts. And saline implants can cause visible, tactile rippling beneath the skin.

Not all doctors, however, are as forthcoming about the risk of additional surgery as Dr. Jewell.

Krista Schell needed two follow-up implant operations within five years of her first. (Jamie Schwaberow for The New York Times)

“My plastic surgeon told me that my saline implants should last forever,” said Krista Schell.

Ms. Schell, 29, who lives in Thornton, Colo., and works for the State of Colorado, said she first spent $6,500 in 2003 on breast enhancement surgery with a doctor in California. She had a second operation with that doctor last April to replace a deflated saline implant whose collapse made her left breast look “hollow”; her implants were still under warranty, but she did have to pay for the trip to California and lost a week’s pay, she said.

Last November, Ms. Schell had a third operation, which cost $6,000, this time with a surgeon in Denver who removed both implants as well as extensive scar tissue, she said. She also lost two weeks’ wages because she had to take time off, she said. The implants had also caused rippling, a lump around one nipple and pain. “If you look at the negatives, you would talk yourself out of getting implants,” Ms. Schell said.

Doctors nationwide performed about 329,000 breast augmentations in 2006, up from about 291,000 in 2005, according to a survey of doctors from the American Society of Plastic Surgeons. But medical experts said they could not determine exactly how long breast implants may last.

“The short answer is, we don’t know specifically how long implants last,” said Stephen Li, the president of a medical device testing company in Sarasota, Fla. Dr. Li, who has served on three of the F.D.A.’s panels that reviewed implant safety, voted to approve silicone implants. He said manufacturers’ data suggested the implants should last at least a decade. “The current implants are no worse than before and ought to be better, based on the clinical and laboratory data, which is the only way you could rationalize approving a device that you have only three or four years of data for.”

As a condition of approval, the F.D.A. asked silicone implant makers to follow their existing study groups for 10 years total and to enroll 80,000 new patients in a database. Both companies also developed extensive informed-consent processes.

Caroline Van Hove, the vice president of corporate communications for Allergan, wrote in an e-mail message that after a patient goes over a detailed checklist of implant information with her surgeon, she signs a consent form acknowledging her understanding of the risks of the surgery.

Although the number of reoperations may seem high ­ about a third of patients in an Allergan study had a second operation within four years of their initial surgery ­ Ms. Van Hove said that less than a third of the follow-up operations involved implant removal. Patients also counted as reoperations if they had surgery to reposition their implants or had biopsies, she wrote. In the same study, even though 28 percent of silicone implant patients needed a second operation within six years, 95 percent of patients were satisfied.

But Eugene Goldberg, a biomaterials professor at the University of Florida, Gainesville, said the F.D.A. should have required longer-term studies before it approved these devices. Research conducted by hip replacement manufacturers, for example, makes it clear that such artificial joints last roughly 10 to 12 years, he said.

“But with breast implants, informed consent is much more fuzzy because each doctor has his own perspective on how long they last, making it difficult for patients to realistically calculate the risks and benefits,” Dr. Goldberg said. He has testified as an expert witness for both plaintiffs and defendants in implant litigation cases and teaches a course in which he uses breast implants as a case study of a badly engineered medical device.

Dr. Linda Huang tells patients that implants should be removed within 10 to 15 years. (Jamie Schwaberow for The New York Times)

Dr. Linda Huang, a plastic surgeon in Denver, tells patients that their implants should be removed after 10 to 15 years. She said she had removed implants from more than 1,000 patients. She charges about $7,000 for breast augmentation; roughly $5,000 to remove implants; roughly $7,500 to replace old implants; and roughly $9,000 for surgery in which she removes implants and performs a breast lift using the patient’s own tissue. “If they would rather spend their money on a trip to Paris than on me, then I recommend they do not have breast augmentation to begin with,” she said.

Surgeons said that implant replacement can be a straightforward operation. But explantation surgery, in which a surgeon removes implants for good along with scar tissue, can be more complicated, particularly for older silicone models.

“If the envelope has broken down and the silicone has leaked out, you are trying to get out all of that goo,” said Dr. Susan E. Kolb, a plastic surgeon in Atlanta who performs three to five explantation surgeries a week. To remove scar tissue, which can adhere to muscles and to the fibrous tissue covering the ribs, some doctors mistakenly remove too much muscle or breast tissue, which can cause chest deformities, she said.

Given the impermanent nature of breast augmentation, it is perhaps fitting that a different ad in the January issue of Elle puts implants on par with a more short-lived purchase: footwear.

You know that feeling when you find the perfect pair,” reads the ad copy running underneath a photo of another naked, contented-looking woman. “And we are not talking shoes.
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Tuesday January 22 2008

Study Says Implants Double Risk of Infection in Breast Reconstruction

By NATASHA SINGER

Breast cancer patients who had reconstructive surgery using implants immediately after mastectomies were twice as likely to acquire infections as women who immediately had breast reconstruction using their own tissue, according to a study published yesterday.

The article in Archives of Surgery, which examined the medical records of breast surgery patients at Barnes-Jewish Hospital in St. Louis from mid-1999 to mid-2002, found that 50 of 949 patients acquired an infection at the surgical site within a year after surgery.

Roughly 12 percent of the infections occurred in mastectomy patients who immediately had implant surgery, compared with roughly 6 percent of infections in those who immediately had breast reconstruction using their own abdominal tissue, the study said. In noncancer patients, about 1 percent of infections occurred after breast reductions and no infections occurred after breast augmentation using implants, the study said.

“The bottom line is that implants are associated with an increased risk of infection in breast cancer patients,” said Margaret A. Olsen, the lead author of the study and a research assistant professor of medicine at Washington University School of Medicine in St. Louis. “The question is what factors contribute to this increased risk and what can be done to prevent it?”

The study noted whether patients had other medical conditions like diabetes, but it did not report how many underwent radiation or other treatments that might have played a role in the infections.

The study did analyze the cost to the medical center of each infection ­ about $4,100 per patient ­ a hospital-acquired complication not covered by managed care, she said.

But both kinds of reconstructive surgery entail risk.

Dr. Stephen R. Colen, the chairman of plastic and reconstructive surgery at Hackensack University Medical Center in New Jersey, said operations using abdominal tissue took several hours longer than implant surgery, increasing the risk of blood clots and lung embolisms. In 2 percent of patients, the transplanted tissue dies, requiring further surgery, Dr. Colen said.

But implant reconstruction inserts a foreign object into the body, providing a surface on which bacteria may grow. And implantation involves a series of procedures ­ including one surgery to insert a skin-stretching device in the chest, followed by saline injections to expand the breast, another surgery to put in a permanent implant and a final surgery to attach a nipple ­ creating more occasions for infection to occur, Dr. Colen said.

Dr. Keith E. Brandt, a professor of plastic and reconstructive surgery at Washington University and an author of the study, said all patients received prophylactic antibiotics at the time of surgery. But postsurgical treatments for breast cancer, like radiation, may weaken the body’s ability to fight infection.