Natural Breast Enlargement

Boost your Bust Natural Breast Enlargement

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Bigger Breast Formula

Bigger Breast Formula is an eBook that shows you different herbs and exercises you can use to grow your breast from small breast to voluptuous breast within 3 to 4 months. The methods taught by this book are 100% natural and completely dependent on herbs and exercises. The book will also teach you foods to eat to aid fast breast growth and certain foods you must avoid. It is perfect for women of all ages who are embarrassed by the small breast and want to naturally increase it without risking breast cancer through plastic surgery or implant. The product was created by Sahar Perske from her grandmother's recipe. The author also claimed she used the same formula you will get to increase her own breast from 32A to 34C. All her friends got a similar result when they tried the product. You will get 24/7 live support and well as money back guarantee when you get the product. More here...

Bigger Breast Formula Summary

Contents: Ebook
Author: Sahar Perske
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Phytoestrogens in the Human Diet

One of the major sources of phytoestrogens in the human diet is the soybean. Genistein is the major phytoestrogen in soybeans. It is present in some Some of the evidence for the role of phytoes-trogens in women's health is circumstantial. It is based, in part, on observations that women who live in countries such as Japan and China, where soy products are widely consumed, have a lower incidence of diseases such as osteoporosis and breast cancer. Clearly, other factors, genetic and environmental, may be contributory. Health claims attributed to phytoestrogens, including genistein, need further evaluation in well-designed clinical trials before such claims can be accepted by the scientific and medical communities or relied upon by those using dietary supplements.

Silicone gel breast implants

In the late 1970s and early 1980s, following the addition of medical device regulation to the FDA's responsibilities, the agency was overwhelmed with an enormous number of devices that had previously been on the market and now needed to be classified and possibly evaluated. Breast implants were among the many devices that were allowed to stay on the market until those reviews were completed. Silicone breast implants had been sold since the 1960s and remained on the market while decisions were made about what kind of safety and efficacy studies might be required. Meanwhile, numerous other silicone implants were considered under the law to be 'substantially equivalent' to breast implants, and therefore allowed to be sold without any clinical trials to prove safety Scientists and physicians started expressing strong concerns about the safety of silicone breast implants, and by the early 1980s, the suspected risks were officially described in the US government Federal Register 11 ....

Breast implants and suicide

Surprising results from a study on mortality among augmentation mammoplasty patients indicated that while overall mortality was slightly lower than the general population, the standardized mortality ratio for suicide was 4.24 (95 CI 0.9-19.2) for this group compared to similar patients undergoing other plastic surgery procedures 67 . Subsequent studies have been consistent with increased suicide risk among Finnish 68 , Swedish 69 , and Danish 70 women with breast augmentation. Whether women who are likely to desire and get cosmetic augmentation are in a high-risk group for suicide to begin with is the subject of debate, with some arguing that they may be and others arguing that the increase in suicide is due to depression over serious adverse events associated with breast implants 71-73 . One study suggests that psychotropic drug use, including antidepressants, may be more likely in women with breast implants compared to population controls or women who have had breast reduction...

Isoflavonoids as Phytoestrogens

Isoflavonoids are a type of secondary metabolite and are found almost exclusively in the legume (pea) family of plants. They are known to function in plant defense. They have been shown to deter herbivores and also to facilitate a plant's defense response to pathogen attack. Interestingly, some isoflavonoids have chemical structures that, in overall size, shape, and polarity, resemble estrogens. The resemblance includes the flatness, or planarity, of the molecules and the positions and orientation of oxygen atoms. Isoflavonoids thathave these molecular characteristics can mimic the biological activity of estrogens and are called phytoestrogens. In terms of biosynthetic origins and chemical structure, phytoestrogens and estrogens are quite different. Phytoestrogens, being isoflavonoids, are phenolic compounds, formed from phenylalanine (an amino acid) by the shikimate pathway. In contrast, estrogens are triterpenoids, formed from acetyl coenzyme A by the isoprenoid pathway....

Infections related to breast implants

Over an 8 month period in 1996, the FDA received two reports of deaths purportedly due to toxic shock syndrome in women after augmentation mammoplasty. There is some risk of infection associated with any surgery, but deaths due to cosmetic surgery are of particular concern because the surgery is elective and usually performed on an otherwise healthy individual. FDA undertook a study to characterize the infection reports related to breast implants. The FDA identified 1971 reports of infections related to breast implants reported during 1977-1997 17 . The study reports included silicone gel-filled breast implants (62 ), saline-filled breast implants (32 ), and tissue expanders (6 ), which are temporary implants to expand the tissue in preparation for a permanent breast implant. Many of the reports merely stated that there had been an infection without any supporting details (45.5 ). The infecting organism(s) was reported in 8 of reports and included Staphylococcus sp., Pseudomonas sp.,...

FDA surveillance studies on breast implants

While there was a dearth of epidemiologic studies on breast implants, there was no lack of reports to the FDA's adverse event reporting systems on breast implants. The FDA receives reports of adverse events on all medical devices through its national reporting program. These adverse events are received from manufacturers, importers, user facilities, and voluntarily from concerned individuals. In order to review all reports on breast implants received by the FDA, three adverse event databases maintained by the FDA were searched. The three databases are The DEN database contains FDA's earliest adverse event reports on silicone breast implants. These reports were received under the mandatory Medical Device Reporting (MDR) program during 1984-1997. The reports reviewed were mandatory manufacturer reports on breast implants that may have malfunctioned or caused or contributed to a death or serious injury. Unlike MAUDE (see below), DEN does not contain device or patient problem codes. These...

Breast implants and mammography

Implants are at the same risk for breast cancer as other women 21 , and are urged to undergo mammography. In the MAUDE database, the FDA identified 66 reported adverse events that described issues with mammography related to breast implants 22 . The majority of these reports, 41 of 66 (62.1 ), described breast implant rupture suspected to have occurred during mammography. Other adverse events reported included crushing implants during mammographic compression, pain during mammo-graphy attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer attributed to implants. It is well known that 22-83 of mammographically visualizable breast tissue may be obscured by breast implants, because radio-dense silicone implants obscure glandular tissue 23 , and special positioning of augmented breasts is required to maximize imaging 24 . Because FDA's study was based on surveillance data, it was not possible to...

Breast implants and connective tissue disease formal reviews

At the time of the Panel meeting in 1992, there were no epidemiologic studies on the association of connective tissue disease with breast implants. Starting in 1994, there were a series of studies published. The first of these studies raised considerable criticism, since the study was funded by breast implant manufacturers 58,59 . Many subsequent studies were also funded by implant manufacturers. The FDA reviewed these studies on breast implant association with connective tissue disease in several publications 60-62 . The conclusions were similar to those reached by others, such as the Institute of Medicine on the Safety of Silicone Breast Implants and the National Science Panel on Silicone Implants 56,63 , who formally reviewed these studies the studies had some flaws and were not large enough to definitively rule out a small increased risk of connective tissue disease in women with breast implants. However, it can be concluded from these studies that there is not a large association...

A brief regulatory history of breast implants

Silicone gel-filled breast implants have been on the market in the USA since 1963. In 1976, the Medical Device Amendments were enacted giving the FDA regulatory authority over medical devices, including silicone gel-filled breast implants 2 . At that time, FDA planned to review medical devices based on their regulatory class (see Chapter 2), with a strategy of first reviewing devices with new technology or devices for which there was insufficient information to assure safety and efficacy. Based on the recommendation of the General and Plastic Surgery Devices Advisory Panel in 1978, breast implants were classified as class II devices those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls. Advisory committees (panels) are groups of experts commissioned by the FDA to provide advice on questions posed by the agency 3 . In 1988, FDA reclassified all...

Breast Augmentation

Litigation involving breast augmentation is even more common than breast reduction. Approximately 44 of all elective aesthetic surgery claims involve augmentation. Setting aside for the moment breast implants and autoimmune disease, the most frequent causes of dissatisfaction are as follow

Estrogens From Plants

While the female hormones called estrogens are common in mammals, only a few plants contain estrogens. Others synthesize compounds which are chemically unrelated to estrogens but resemble them in their molecular size and shape. These compounds are called phytoestrogens (plant estrogens) and may, when ingested by animals or humans, have properties similar to those of mammalian estrogens.

Registries sponsored by professional organizations

The American Society of Plastic Surgeons (ASPS) has been collecting data on breast augmentation and reconstruction, along with other plastic surgery procedures, since 1992. ASPS has partnered with DataHarbor Inc., a healthcare industry data management and technology development company, to collect, analyze, and present the data which are kept in the National Clearinghouse of Plastic Surgery Statistics 39 . This database is based on surveys sent to more than 17 000 board-certified physicians (mostly in the USA and Canada), and is focused on type of surgery procedures, including procedures with breast implants. No information on adverse events was collected. The CDRH used the registry to obtain information on statistical trends of cosmetic and reconstructive plastic surgery. ASPS has also collected data on breast augmentation and reconstruction along with other plastic surgery procedures with national telephone surveys conducted by TeleNation, a service of MarketFacts, Inc. Each week...

Consumer concerns about device manufacturers and their research

As these examples illustrate, consumers or their physicians were the first to complain about the adverse reactions to these medical devices, and in most cases the manufacturers defended their products and challenged consumers in court. In some examples, such as tampons, healthcare professionals were instrumental in bringing attention to the problem in others, physicians tended to assume that the medical devices were safe and unrelated to the problems being reported. In the case of breast implants, it was only when it became clear that there were no safety data to back up company claims, and internal corporate documents indicated the possibility of a cover-up, that the products were withdrawn from the market or restricted, usually with belated pressure from the regulatory agencies of countries such as the USA and Canada. In recent years, the European Commission has applied pressure on EU countries to institute safeguards that implant manufacturers and plastic surgeons were not...

Consumer group accomplishments mixed results

As a reflection of the growing clout of consumer organizations, in September 2005, Health Canada held its first-ever public meeting of an advisory panel, for the review of a controversial medical device silicone gel breast implants. The public meeting was in response to consumer complaints about a secret meeting that took place in March 2005, with an 'independent' advisory panel. The controversy arose when it became known that the 'expert advisors' who participated in the panel meeting included two men who were paid consultants to one of the breast implant manufacturers, Inamed, whose products were being reviewed by Health Canada. In fact, both 'expert advisors' had testified on behalf of the safety of Inamed silicone gel breast implants at an FDA advisory panel in April of the same year. When consumer groups pointed out that paid consultants were unlikely to make unbiased judgments about the product, Members of Parliament joined them in demanding a more open, balanced process. As a...

The roles of surveillance and epidemiology

Silicone gel breast implants, either intact or ruptured Polyurethane foam has been used to cover implanted electric lead wires 34 , silicone breast implants 35 , and as a potting material in hemodialyzers 33 . It has been shown to be hepatotoxic in humans 33 These reduce oxygen flow to the cornea if wear is prolonged, an ulcer can form 36,37

Potassium Sparing Diuretics

Hyperkalemia (increase in potassium in the blood), a serious event, may be seen with the administration of potassium-sparing diuretics. Hyperkalemia is most likely to occur in patients with an inadequate fluid intake and urine output, those with diabetes or renal disease, the elderly, and those who are severely ill. In patients taking spironolactone, gynecomastia (breast enlargement in the male) may occur. This reaction appears to be related to both dosage and duration of therapy. The gynecomastia is usually reversible when therapy is discontinued, but in rare instances, some breast enlargement may remain.

Body Image And Physical Rehabilitation

Disfigurement is never pleasant, and in this age of body-building, facelifts, breast implants, and bikinis, the slightest imperfection or scarring can make a patient feel like the Phantom of the Opera. If the patient has a religious background, this can be a powerful resource, and I emphasize that the real self is still there, and they can learn to forgive anyone who doesn't know that fact and looks askance. Patients without spiritual resources need to be approached with a more Ericksonian technique, utilizing whatever ego strengths are available.

Silicone gelfilled breast implant reports 19841995

By the end of 1995, the FDA had received 98 405 adverse event reports on silicone gel breast implants (this does not include reports for saline breast implants) 15 . Many of these were reported to FDA after the 1992 Panel meeting described above (Figure 27.2). It is not unusual for media coverage to increase awareness and reporting of adverse event reports. Between 1984 and 1991, there were a total of 3479 reports for silicone gel-filled breast implants. In 1992 alone, there were 27 130 reports entered into the database this rose to 33 982 reports entered in 1994. Thus, there was a > 2000 increase in manufacturers' reports on silicone gel-filled breast implants from 1991 to 1992. The large increase in reports was attributed to multiple reasons, including reporting on individual breasts (e.g. if women had two ruptured implants, each rupture was reported as a separate report) multiple reports of the same adverse event when multiple sources reported the same adverse event (e.g. if the...

Effects of mothers implants on offspring

Another issue which has been of continuing concern to women with implants has been the possibility that a woman's implants affect her offspring. Some suggested mechanisms by which this might occur are via placental transmission of siloxanes (the building blocks of silicone), silicone, or other chemicals from breast implants 25 . Another possible source is from breast milk if contaminated with these compounds. Potential maternal-child health issues related to breast implants fall into three main categories (a) female reproduction, including infertility and spontaneous abortion (b) potential teratogenic effects of silicone and other chemicals in implants and (c) lactation quality (purity and safety of milk) and quantity (ability of women with implants to nurse). There is very little published information on any of these issues. FDA searched MAUDE and DEN for reports of maternal-child problems attributed to a woman's breast implants 26 and identified 339 relevant reports. Nearly half of...

Reoperations after mammoplasty

Re-operations related to complications and problems with implants have emerged as a major issue with implants. Several studies indicate that women with breast implants are likely to undergo additional surgeries after implantation, in order to address complications or fix unacceptable cosmetic defects due to breast implants 54,55 . Complications and problems include a wide variety of issues, such as breast implant rupture, capsular contracture, infections, gel migration, chronic breast pain, changes in nipple sensation, hematoma, seroma, extrusions, and cosmetic irregularities. Repeated surgeries (re-operations) expose women to all the risks inherent to surgery and also demonstrate that problems with implants persist over a long period of time. The 1999 Institute of Medicine report on the safety of silicone implants stated the following on re-surgeries, due to breast implant rupture and other complications 'In general, the frequency of reoperations and local complications is sufficient...

Noninvasive Evaluation

Myocardial perfusion imaging with thallium has improved the diagnostic accuracy of noninvasive stress testing and increased sensitivity to 84-90 and specificity to 75-87 in women, but the diagnostic accuracy may be reduced in patients who are obese or have large breasts. Accuracy may be improved further with technetium-99m (Tc-99m) ses-tamibi, which has a similar sensitivity (85-90 ) to thallium, while the specificity of Tc-

Foreword by D Millesi

Many new techniques are at our disposition and the number is constantly growing. Apart from basic techniques, detailed technical points become more and more important for the successful outcome. It is nearly impossible to provide a complete survey of all techniques available today in a single textbook, not to mention the variety of technical details that are frequently not described. It is to W. L. Mang's credit that he elected the forum of a manual instead of a large textbook to present his great personal experience. In the first volume of his manual, W. L. Mang described his personal experience with rhinoplasty, rhytidectomy, eyelid surgery, and otoplasty. His techniques and his tricks are presented in the form of very instructive sketches, and any surgeon who wants to enter the field of aesthetic surgery can do this easily following the impressive illustrations. Now the second part of the Manual of Aesthetic Surgery is available. It covers liposuction, breast implants, hair...

Http Bbs Topics Answers Ans00667.html

TDA and polyurethane breast implants http www.US bbs topics ANSWERS ANS00667.html 5. Hester TR Jr, Ford NF, Gale PJ, Hammett JL et al. Measurement of 2,4-toluendiamine in urine and serum samples from women with Meme or Replicon breast implants. Plast Reconstr Surg 1997 100 1291-1298. 7. Council on Scientific Affairs. American Medical Association. Silicone gel breast implants Council Report . J Am Med Assoc 1993 270 2602-2606. 9. Kessler DA, Merkatz RB, Schapiro R. A call for higher standards for breast implants. J Am Med Assoc 1993 270 2607-2608. 10. Kessler DA. The basis of the US FDA's decision on breast implants. N Engl J Med 1993 326 1713-1715. 11. Bright RA, Jeng LL, Moore RM. National survey of self-reported breast implants 1988 Estimates. J Long Term Eff Med Dev 1993 3 81-89. 12. Terry MB, Skovron ML, Garber S, Sonnenschein E, Toniolo P. The estimated frequence of cosmetic breast augmentation among US women, 1963-1988. Am J Publ Health 1996 86 891-892. 13. Cook RR,...

Proscar Longterm Efficacy And Safety Study

No difference in the incidence of serious adverse events between the two groups was observed. In fact, the only adverse effects that were drug-related and for which the incidence was greater than or equal to 1 and greater than placebo were symptoms of sexual dysfunction (impotence, decreased libido, decreased ejaculate volume, ejaculation disorder), breast enlargement tenderness, and rash. Interestingly, two cases of breast cancer were diagnosed in the placebo group neither man had an antecedent history of gynecomastia. No cases of breast cancer were detected in the finasteride group during the study.

FDA surveillance systems

The data elements per event include the manufacturer, model-specific device, event and receipt dates, and patient and device problem codes. The FDA uses the information reported through these programs to assist in the early identification and characterization of emerging medical device problems and related public health issues. The reports are used for health hazard evaluations, product assessments, trend analysis, regulatory actions, or for developing effective education programs and timely feedback to healthcare practitioners and medical device manufacturers. Case series studies conducted using MAUDE data looked at the adverse events associated with various devices, including breast implants 13-15 , gastric band device 16 , pulmonary artery catheterization 17 , gloves 18 , surgical staplers 19, breast pumps 20 , and infusion pumps 21 .

Governmentsponsored registries

The most valuable data in this registry are its pathology results of a representative variety of explanted breast implants received by the registry. There are more than 175 explanted breast implants in the registry. Capsular tissues are available in approximately 75 of these cases . The data in this registry can be used to address some unanswered questions, such as whether silicone migrates in the body, etc. 48 . Danish Registry for Plastic Surgery of the Breast In addition to the major databases of breast implants as part of cosmetic and reconstructive surgery, described above, there are breast implant registries in the UK and Scandinavian countries. As a result of a centralized healthcare system and population data collection system in those countries, data collection is much more complete than that in the USA, and the data can be linked to other population data as needed. and public clinics, representing more than 80 of the plastic surgery clinics in Denmark. As of November 2001, a...

Devices used in corrective surgeries during adolescence

Recently there has been an increase in the number of teens undergoing breast implant surgery. Saline breast implants are FDA-approved in persons 18 years and older. However, being bombarded by the media images, small-breasted girls may feel inadequate and opt for a breast implant augmentation with unrealistic expectations. A large Danish cohort study of young women opting for enhancing breast augmentation with implants also supported the need to evaluate young women for underlying psychiatric problems 55 . The American Society of Plastic Surgeons website reports 3841 breast augmentations among women aged 18 years or younger. This 'cup and gown' procedure is sometimes paid for by parents as a high school graduation gift.

Diana M Zuckerman PhD

In the 1990s, very few consumer advocates or nonprofit organizations focused any attention on medical devices. Even so, the few groups that were concerned about medical devices generated considerable public attention regarding the questionable safety of specific devices, such as breast implants, jaw implants, and fetal monitors, especially in the USA, Canada, and the UK. Organizations such as the National Women's Health Network, Canadian Women's Health Network, Public Citizen Health Research Group, and the TMJ (temporamandibular joint) Association were vocal critics of specific implants, and they were joined by the National Research Center (NRC) for Women & Families when that research and advocacy organization was founded in 1999. In the last few years, increased attention has been given to the benefits of medical devices for life-saving procedures as well as common age-defying cosmetic solutions, and the risks have also come under greater scrutiny. In 2001, while working with an...

Centers for Disease Control and Prevention National Center for Health Statistics

This national survey provides information on the health of the US civilian population 65 . It is a cross-sectional survey with a multistage area probability design to achieve a representative sample of housholds. The questionnaire consists of basic health questions, demographics and current health questions. The CDRH used the 1988 Medical Device Supplement to the to the NHIS to provide prevalence of various implanted devices 66 , such as artificial knees 67 , internal orthopedic fixation devices 68 , intraocular lenses 69 , heart valves 70 , pacemakers 71 , aortic valves 72 , breast implants 73 , and tympanostomy tubes 74 .

Breast implant rupture

Implant rupture was mentioned as an issue with implants in 1992 9 and emerged as the most frequently reported problem in adverse event reports to the FDA (see above). Manufacturers opined that the rupture rate for breast implants was 0.2-1.1 , but the American Medical Association taskforce suggested that it could be as high as 4-6 7 . Manufacturers made the argument, in meetings with the FDA, that when the number of ruptured implants reported to them was used as the numerator and the number of implants ever sold was used as the denominator, implant rupture could be seen to be rare. Their analysis was problematic, since it is well established that adverse events are under-reported at an unknown but significant rate. Neither did this consider that the number of implants sold was not equal to the number of women exposed (or even breasts exposed), since practices with implants included removing and replacing ruptured implants stacking multiple implants in a surgical pocket discarding...

Surgical Planning

A novice in breast augmentation surgery should start with implants that are not too large (no larger than 320 g) and begin by using the safest access. This is access in the inframammary fold (3). This access (approximately 3-4 cm) is free from problems, can be clearly seen, and is easy to learn. It ensures safe dissection in view and low-risk introduction of the implants.

Diet and Social Life

It is believed that this development necessitated far more intensive child care and a closer bond between the parents, which nature then enforced by increasing the mutual sexual attraction of the parents through anatomical changes (large breasts and nonseasonal sexual receptiveness), and mental stimuli (an intense partner bond and monogamy). Greater infant dependency may also have stimulated a division of labor short-range food collecting, rearing, and teaching of the children being performed by women, and longdistance collecting, scavenging, hunting, and fighting by men. More complex social interaction during group living, hunting, and child care also led to the development of sign language and the first forms of speech. With greater handling skills, and an increasingly shared knowledge about hunting, food

Plastic Surgery

Stomach, buttocks, thighs, or other areas. Briefly, in this procedure, an incision is made in the skin, a cannula (tube) is inserted, and the fat is suctioned out. Other procedures commonly performed by plastic surgeons include facelifts, breast augmentation (or reduction), rhinoplasty (reshaping the nose), hair transplants, hand surgery, skin grafts for burn survivors and repair of cleft palate (both usually done in a hospital setting), breast reconstruction associated with cancer surgery, and other disfiguring malformations of the face and head. The top three cosmetic procedures in the United States are liposuction, breast augmentation, and eyelid lifts.

Biological Implants

The most important principle in aesthetic surgery is health before beauty. Avoid all new materials that have not undergone long-term testing. This applies not only to injectable materials but also to breast implants and suture material. Injectable collagen is an ultrapurified bovine collagen of type I. Depending on the concentration (35-65 mg ml), this material is available in various ready-to-use ampules with a local anesthetic.

Endocrine disrupters

Endocrine-disrupting chemicals may be pesticides or metabolites of pesticides, as well as industrial and household chemicals. Oestrogen-active compounds are also found naturally in plants, and are called phytoestrogens. A well-known case of phytoestrogen action is the occurrence of isoflavonoids in Australian clover, Trifolium subterraneum (Leguminosae), which was identified as the cause of impaired sexual performance in sheep. Phytoestrogens from soybean (Glycine max, Leguminosae) are considered as an alternative to oestrogen therapy for menopausal symptoms. Why plants would produce compounds that affect the endocrine system of vertebrates is not clear. Maybe it is just a side effect, while the main function of these compounds lies elsewhere. For example, isoflavonoids are also implicated in signalling between plants and microorganisms in the rhizosphere. Still, it is often assumed that plants have evolved phytoestrogens as a defence strategy against herbivory. If this is the case,...

Endocrine Disruptors

Evidence is accumulating that many compounds present in the marine environment have the potential to interfere with the actions of endogenous hormones. These compounds are known as endocrinally active compounds (EACs), since they affect target receptors of sex hormones as well as other organs 44 . The EACs can be classified as natural sex hormone-like compounds (e.g., phytoestrogens and mycoestrogens) and anthropogenic sex-hormone-like compounds (e.g., pharmaceuticals, estrogens, androgens, phenolic compounds, polychlorinated compounds, and phthalates). In the marine environment, the most relevant in terms of concentration, persistence


Prolactin normally stimulates breast tissue growth, differentiation, and lactation. Gynecomastia (breast enlargement) and galactorrhea (lactation) are expected consequences of antipsychotic-induced hyperprolactinemia in both men and women, although the actual risk of breast-related side effects is not well delineated (Schreiber and Segman 1997). Estimates of the frequency of galactorrhea in women treated with typical antipsychotics vary, with reports of up to half of premenopausal women experiencing galactorrhea, but this side effect is rarely reported in men (Ghadirian et al. 1982 Gitlin 1994 Inoue et al. 1980 Windgassen et al. 1966). One of the few studies to date that has systematically inquired about breast changes naturalistically followed 150 women with schizophrenia treated for 75 days with a variety of typical antipsychotics (Windgassen et al. 1996). Nineteen percent (28 150) of the women admitted to galactorrhea. The mean prolactin value for these patients was 55 ng mL, but 4...


A pilot study published by De Cassia Novaes in 2003 reports on a treatment series with 59 patients. Aside from mild to moderate immediate redness, swelling, and pain, which dissipated in less than 36 h, no long-term side effects were observed (De Cassia Novaes and Berg 2003). In 2004, Breiting reported the results of a retrospective case series of 104 patients, 49 of whom had undergone breast augmentation. Palpable regional lymph nodes were observed in ten patients, which was considered to be within the range of usual coincidental findings. Migration of the gel was demonstrated in three women who had their nasolabial folds treated. No long-term adverse effects were observed in this study, which reported an average observation time of 3.9 years (Breiting et al. 2004).

TMJ Implants

The examples of the Dalkon Shield, tampons, silicone gel breast implants, and TMJ implants all indicate that there can be substantial risks for medical devices used within the body. The latter three examples also indicate how, even in a country that regulates medical devices, pre-1976 'grandfathered' devices have been allowed to be sold that can have devastating effects on human health. Also, when regulators in one country demand that a product be removed from the market, companies can continue to sell their products in other countries with less stringent regulations for medical devices. Particularly in small countries, where the number of patients using the products is modest, or in products that work well at first but fail over time, the risks of a defective or poorly designed device may not be noticed for many years.

Tissue reactions

Many types of reactions have been noted (see Table 19.2). These reactions may be mild or severe. Simple irritation has been noted for devices in direct contact with skin, for example, gloves and the external part of the cochlear implant system 6,7 . Different types of allergic reactions have also been noted the examples in the table feature latex gloves 5,8-10 , midline vascular catheters 11,12 , and dialysis membranes 13,14 . An especially severe type of reaction that seems to be an allergic reaction but has a different mechanism is anaphylactoid reaction, which has been noted for various blood filters polyacrylonitrile hemodialysis membranes 15-20 , low-density lipoprotein columns 21-24 , and bedside leukocyte filters 25 . Other devices, such as prosthetic heart valves, can cause blood clots 26 . Neurologic damage can result from the use of very old cellulose acetate hemodialysis membranes 27-29 . Granulomatous foreign body reactions can result from silicone implants (see Chapter...

Breast implant types

There are two types of breast implants currently available in the USA, silicone gel-filled breast implants and inflatable saline-filled implants. Both types of implants have a silicone elastomer shell (envelope) which is filled with either silicone gel (see e.g. Figure 27.1) or sterile isotonic saline. Some implant models have both a silicone gel-filled lumen and a saline-filled lumen. These bi-lumen implants are classified as silicone gel implants because of their silicone gel component. Nomenclature for breast implants may be confusing, since in many publications 'silicone implants' mean silicone gel-filled implants, and in other publications this term refers to either silicone gel-filled or saline-filled implants (which have a silicone elastomer shell). For the purposes of clarity in this chapter, breast implants will mean all types of breast implants, and silicone gel-filled breast implants will be specified as such.

Joan Ferlo Todd

Breast implants have been a continuing issue for the regulatory agencies around the world for over two decades. In this chapter, we will discuss types of breast implants, a brief regulatory history of breast implants, US Food and Drug Administration (FDA) studies using passive surveillance (MedWatch Medical Device Reports), FDA studies on breast implant rupture, formal reviews of epidemiologic studies on breast implants and connective tissue disease, and the emerging issue of suicide and breast implants.

Related syndromes

Scleroderma-like illnesses have been reported after exposure to bleomycin, vinyl chloride, and silica dust. An association between silicone gel-filled breast implants and the development of scleroderma has been suggested, but epidemiologic studies have not supported a causal relationship. A scleroderma-like illness appeared in Spain in 1981 and was ultimately linked to ingestion of a toxic rapeseed oil. Ingestion of contaminated

Review of literature

Identification of data sources is needed for medical device epidemiology 1 '. Many focused on nosocomial infection issues, where the device's use contributed to the episode. The remainder involved laparoscopic entry access injuries 2,3 , atrial defibrillation devices 4 , IUDs 5 , and silicone breast implants 6-12 . Searching for a specified device produces similar results. Using the MeSH headings ' Defibrillators, Implantable MeSH AND Epidemiology MeSH ' yielded no hits, while the headings ' Epidemiology MeSH AND (Breast Implantation'' MeSH OR Breast ImplantsMeSH )' yielded three hits. Note, however, that the MeSH lexicon must be used carefully. Substituting 'epidemiology' subheading for the MeSH term yields 163 hits for breast implants, although many of the hits were less precise.

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