6 Iatrogenic disorders following breast surgery

Synopsis

Iatrogenic deformity after breast augmentation can result from the following factors:

Introduction

The word “iatrogenic” is defined as illness caused by medical examination or treatment. During the early years (1900–1950), breast augmentation was usually accomplished by the injection of foreign material, generally paraffin or liquid silicone. Iatrogenic disorders were very common during this period. They resulted primarily from the foreign material that was injected. Breast implants were introduced in the early 1950s. They resulted in a totally different group of iatrogenic disorders. Some of these were due to the implants. Others were due to untoward complications, surgical techniques, and patient anomalies. The purpose of this chapter is to review the iatrogenic disorders that can occur after breast augmentation.

Injection materials

The history of breast augmentation occupies the past 110 years. Fewer surgical procedures have a history as fascinating as breast augmentation. There have been four main eras of injectable materials for breast augmentation. Each of these eras has produced iatrogenic breast conditions of major proportions:

• Paraffin (1899–1914)

• A plethora of material (1915–1943)

• Liquid silicone (1944–1991)

• Polyacrylamide hydrogel (PAH) (1988–2009)

Paraffin (1899–1914)

Paraffin injections ^1,² were used extensively for breast augmentation from 1900 to 1914. Paraffin is a group of hydrocarbons, which is saturated with carbon to hydrogen bonds, making them relatively inert. The basic repeating unit in the polymers is: –(CH2) n– . Paraffin exists as a hard form (wax) and a soft form (Vaseline). Paraffin was usually liquefied in a warming chamber prior to injection. The first published report of paraffin injections into a patient dates back to a report by Gersuny, of Vienna, in 1899. A young man had undergone a bilateral orchidectomy for tuberculous disease. Gersuny injected paraffin into his scrotum, so that the patient could pass the physical examination necessary to join the army. Paraffin injections were subsequently used extensively for breast augmentation in Europe, the Far East and North America, until about 1914, when its complications became known. However, in the Far East, the practice was continued into the 1950s and 1960s.

The early results of paraffin injections were often quite acceptable. The complications that followed frequently did not show up until 5 or 10 years later. The local complications included migration, ulceration, fistulae, infection and necrosis. A new term was coined – “paraffinomas” – to describe these changes, which involved both skin and underlying soft tissues. These complications would frequently lead to breast amputation. Ultimately, in his 1925 textbook, H. Lyons Hunt called an “inexcusable practice” and blamed “beauty doctors and other such imposters” for its continued use. The disastrous experience with paraffin was to live on in the collective memory of the plastic surgery profession.

Figure 6.1 shows the clinical status of a woman who received paraffin injections in the Far East 40 years earlier. She had undergone multiple debridement procedures and bilateral mastectomies over the years to treat multiple ulcers, infections and fistulae. She continued to suffer from these problems.

Fig. 6.1 Clinical status of a woman who had received paraffin injections in the Far East 40 years previously. She has had many operations over the years, including bilateral mastectomies, to treat ulcers and fistulae. She continues to suffer from these problems.

After the paraffin saga, there was a period of approximately 30 years during which a huge plethora of materials was used for breast augmentation. The list of these materials was limited only by the extent of man’s imagination. During this time, the following materials were used: ivory balls, glass balls, vegetable oils, mineral oil, lanolin, beeswax, shellac, silk fabric, epoxy resin, ground rubber, ox cartilage, sponges, sacs, rubber, goat’s milk, Teflon, soybean and peanut oil, and glazier’s putty. The outcome with each of these materials was similar – chronic inflammation, infection, and foreign body granulomas. Many of the materials had severe tissue reactions. Infections were common. Ultimately, none of the materials proved to be useful for breast augmentation.

Liquid silicone injections (1944–1991)

In 1943, the Dow Corning Corporation and Corning Glass formed a joint venture in the United States, to develop silicone products to be used for military purposes during the Second World War. Ultimately, these silicones were used for waterproofing, to prepare grease and oil products for aircraft, to insulate electrical transformers, and to prepare high-temperature-resistant rubbers. When the war came to an end, Dow Corning redirected their efforts to the formulation of medical-grade silicones. Medical grade refers to material that is pure in quality, sterile, and of constant viscosity. Medical-grade silicone was not available until 1960.

Near the end of the Second World War, prostitutes in Japan used industrial-grade liquid silicone extensively. United States’ servicemen preferred women with larger breasts than those of Asian women. Barrels of industrial-grade silicone began to mysteriously disappear from Japanese docks, destined for injection into the breasts of these unfortunate women.

Many of the complications of paraffin injections were repeated – a half-century later – with silicone injections. Some of them were even worse, because of impurities and additives in the silicone preparations. Only industrial-grade silicone was available. This material was never meant for injection because of its impurities. In addition, in many of the preparations, contaminants were purposely added to the injected material. Their purpose was to cause a sclerosis reaction in the breasts, to contain the liquid silicone and to hopefully prevent it from migrating through the breast tissue to other sites. Common sclerosing agents included croton oil, cobra venom, olive oil and peanut oil. The adverse effects of injected liquid silicone were very similar to those of paraffin. These included: migration of silicone to other parts of the body, inflammation, discoloration, and the formation of granulomas, ulceration and fistulae.

During the late 1950s and 1960s, a number of physicians and lay clinics in North America turned to liquid silicone injections for augmenting women’s breasts. Las Vegas became a “center” for silicone injections. In the entertainment business, these silicone injections were referred to as “Cleopatra’s Needle”. They were often injected into woman’s breasts under great pressure, using equipment resembling a caulking gun. It has been estimated that in Las Vegas in the 1960s, liquid silicone was used to inject the breasts of over 10 000 women. Ultimately, in 1975, because of the horrendous complications from silicone injections into breasts in Las Vegas, the state of Nevada declared that it was a felony to inject silicone or to transport liquid silicone across the state line.

In 1966, the FDA authorized nine plastic surgeons and one dermatologist to investigate the cosmetic use of Dow Corning’s highly purified medical-grade liquid silicone (Dow Corning 360) for certain specific problems in patients. The study was limited to only these particular physicians. However, over time, many other physicians used this medical-grade silicone, although they were not part of the official study. Subsequently, Dow Corning decided to discontinue efforts to gain FDA approval, because they could not prevent misuse of the product.

Figure 6.2 shows the clinical status of a woman who received silicone breast injections in San Francisco in 1972. Over the next 30 years, much of the silicone has migrated to her abdomen. Her breasts show chronic inflammation from silicone granulomas that have infiltrated the overlying skin. Mammography of breasts injected with silicone usually demonstrates multiple cystic masses, ranging from 0.2 cm to 2.0 cm in diameter, often with calcification (Fig. 6.3). This can interfere with clinical and radiological breast evaluation.

Fig. 6.2 Clinical status of a woman who received breast silicone injections in San Francisco in 1972. Over the following 30 years, much of the silicone has migrated to her abdomen. Her breasts show chronic inflammation from silicone granulomas that have infiltrated the overlying skin.

Fig. 6.3 Mammography following liquid silicone injections demonstrates multiple cystic masses ranging from 0.2 cm to 2.0 cm in diameter, often with calcification.

Figure 6.4 shows the microscopic appearance of a silicone granuloma, which has been excised from silicone-injected breast tissue. This shows extensive destruction of the breast parenchyma. Silicone appears as empty spaces or vacuoles, where it has been washed out during tissue preparation. Histology also shows occasional giant cells, vascular obliteration, a chronic inflammatory response and destruction of the breast parenchyma.

Fig. 6.4 Histology of breast tissue which was injected with liquid silicone. There is extensive destruction of breast parenchyma. Silicone shows up as empty spaces or vacuoles, where it been washed out during the tissue preparation. There are occasional multinucleated giant cells, areas of vascular obliterans, and chronic inflammation (H&E stain, magnification ×50).

The reactions of liquid silicone injected into breasts vary considerably. Not all patients appear to be equally susceptible to the deleterious effects of silicone. Some patients do not develop significant symptoms at all. In general, the average time from injection of silicone to the development of complications is 9 years. There are two main types of clinical presentations. The first type of patient usually presents with multiple and/or painful lumps in their breasts. In some patients, these may occur within two to three years of injection. In other patients, they may not occur until 10 or 15 years after injection. Many patients have also had multiple injections of cortisone, in an attempt to decrease the inflammatory reaction. This can complicate the clinical picture.

The second type of patient presents with skin inflammation and impending breakdown (see Fig. 6.2). As the silicone invades the dermis and epidermis of the overlying skin, the breast may show varying stages of skin circulatory difficulties, from fine telangiectasia to necrosis. Skin capillary filling time is increased. Migration of the silicone is common.

Injectable liquid silicone has many qualities that could make it a suitable material for long-term soft-tissue augmentation. At the same time, there are still many unanswered questions pertaining to potential complications that need to be addressed before it can be considered for this purpose. A well conducted, controlled, long-term study is needed to answer these questions.

Polyacrylamide hydrogel (1988–2010)

During the past 20 years, a newer class of injectable material has been used, mainly in Ukraine, Russia, and China: polyacrylamide hydrogel (PAH).³ It is an extensively cross-linked polymeric soft tissue filler substance that has been used extensively for breast augmentation. Initially, PAH appeared to be an ideal soft tissue filler material. However, several reports have subsequently appeared, demonstrating that numerous complications can occur after PAH injections. These can develop from several months to three years after injection. They include: migration, breast lumps, pain, infection, firmness and disfigurement. The use of PAH has now been banned in China and many other countries.

Figure 6.5 shows a 29-year-old woman who received PAH injections into both breasts in a plastic surgery clinic in Iran 1-year previously. Over the following year, she developed visible and palpable tender masses. A T1-weighted magnetic resonance imaging study of the left breast shows low signal intensity material, mostly superficial to the pectoral muscles, in the subglandular plane (Fig. 6.6). The PAH was easily removed through bilateral inframammary incisions. It had the consistency of “cream of wheat” (Fig. 6.7). The patient underwent an uneventful subglandular breast augmentation with cohesive gel implants 2 years later.

Fig. 6.5 Clinical status of a 29-year-old woman, 1 year after she received breast PAH injections in Iran. Visible and palpable tender masses are apparent in the inframammary and inferior-lateral aspect of both breasts.

Fig. 6.6 A T1-weighted image of the left breast (Fig. 6.3) showed low signal intensity material, mostly superficial to the pectoral muscles, in the subglandular plane.

Fig. 6.7 The PAH was easily removed through bilateral inframammary incisions. It had the consistency of “Cream of Wheat”.

This particular patient, who was injected with PAH in Iran, showed only minimal complications with migration and surface lumps in her breasts. However, we have seen other patients (e.g., from Russia), who have presented with major recurrent infections and multiple sinuses, and fistulae, many years after receiving PAH injections (Fig. 6.8). There may be different chemical formulations and different purifications of PAH in certain areas of the world.

Fig. 6.8 This 32-year-old woman received PAH injections 6 years earlier in Russia. She has been plagued with recurrent infections and draining sinuses.

Breast implants

The sponges (1951–1962, the early years)

The initial breast implants were developed in 1951. This introduced a totally new concept. Solid devices were now inserted behind the breast tissue to augment the size and shape of the breast. Breast implants have evolved over the past 60 years. Ivalon (polyvinyl alcohol) (Beverly Hills Surgical Supply Company) sponge was the first significant implantation material used for breast augmentation. The original sponges were manufactured by Clay-Adams Company (USA) and the Poly-Plastic Company (USA). Pangman and Wallace ⁴ published the first study on these implants in 1955. They surmised that the outer surface of these sponges could become infiltrated with vascularized tissue, to produce a “living sponge”. Subsequent investigations showed that this process did not occur. Although the initial results were encouraging, within 1 year of augmentation, breasts became very firm and lost over 25% of their volume. Pangman introduced many modifications of his implant, including: a double-layered construction and wrapping the implant in a polyethylene sac. In spite of these modifications, all of these patients developed major firmness and shrinkage of their implants.

Figure 6.9 shows the breast appearance 19 years after augmentation with Ivalon double-layered sponge implants (circa 1958).⁵ This patient presented with bilateral very painful capsular contractures. She was subsequently treated by explantation and capsulectomy.

Fig. 6.9 Breast appearance 19 years after augmentation with Ivalon double-layered sponge implants (circa 1958). She presented with bilateral painful capsular contractures. All sponge implants tended to have this same outcome. This patient was treated by explantation and capsulectomy.

From 1952 to 1962, other sponges were also used for breast augmentation. These included: polyethylene sponge, Etheron (a polyether sponge), and Polystan (fabric tapes that were cut by machine and then wound by hand into a ball). Another type of implant that was used from 1958 to 1962 consisted of shredded polyethylene strips, each about 2 mm wide, enclosed in a casing.⁶

All of the implant materials from this era had a similar outcome. Within a year of implantation, they developed major and painful breast firmness and a loss of breast volume. This was due to capsular contracture, a process that would lead to collapse of the sponge and which would continue to plague plastic surgeons and their patients for the next 50 years. Many of these sponges also developed infection. Because of this high complication rate, the popularity of breast augmentation surgery declined progressively until 1963, when the silicone gel implant was introduced.

Silicone gel implants

In 1963, Cronin and Gerow introduced silicone gel implants, as the new “natural feel” implants. This revolutionized breast augmentation surgery. Subsequently, newer types of silicone gel implants were introduced. From 1963 until 1992, silicone gel breast implants were far from being homogeneous. About 10 different companies manufactured many different types of silicone gel breast implants. They obtained their raw materials for gels and shells from a similar number of other companies, who entered and left the market at intervals. Many of the suppliers and manufactures changed their names and ownership over the years. Most of the companies no longer exist. No formal process of FDA pre-market testing was in effect until 1988.

Silicone gel breast implants were originally implanted in small numbers, and these numbers slowly increased.⁷ From 1962 to 1970, only about 50 000 women received gel implants in the United States. Subsequently, this number rose annually. In 1982, about 100 000 women received silicone gel implants. From 1983 to 1991, this number remained constant at 120 000–130 000 per year. Estimates indicate that, by 1992, over 2 million women had received breast implants globally, and that over 95% were silicone gel implants. Over half of these implants were inserted in North America.

As breast augmentation surgery continued to flourish, iatrogenic disorders from this procedure became more common. These disorders included: implant disruption, hematoma, infection, capsular contracture, capsular calcification, implant displacement, and other complications.

Implant disruption: silicone gel implants

Most of the implant disruption studies ⁶^–⁹ were done in the 1990s. Before 1993, the incidence of implant disruption was thought to be very low. In January 1992, Dr David Kessler, the then Commissioner of the FDA, called for a moratorium on the use of silicone gel breast implants. Following this, hundreds of thousands of women with gel implants rushed to have their implants removed. They perceived that there was an association between their implants and medical disease. Why else would they have been banned? This huge number of women with gel implants provided very large numbers of implants for disruption assessment.

From 1963 to 1992, there have been three generations of gel implants, and a number of other lesser variations. First generation implants (1963–1972) had a thick gel and thick wall. They have generally remained intact over the years. Most first generation implants were “tear-drop shaped”. They had woven Dacron (DuPont Co, DE) patches on their posterior surfaces (Fig. 6.10) to anchor them to the chest wall in an attempt to restrict ptosis. These patches adhered very tenaciously to adjacent tissues. Subsequently, when capsular contracture developed, these patches could cause major breast distortion. In addition, significant torsion could be placed at the site of this patch. This could lead to exposure with subsequent extrusion of the implant (Fig. 6.11).