breast implant



A breast implant is a prosthesis used to enlarge the size of a woman’s breasts (known as breast augmentation) for cosmetic reasons, to reconstruct the breast (e.g. after a mastectomy or to correct genetic deformities), or as an aspect of male-to-female sex reassignment surgery. According to the American Society of Plastic Surgeons, breast augmentation is the third most commonly performed cosmetic surgical procedure in the United States. In 2005, 291,000 breast augmentation procedures were performed.

There are two primary types of breast implants: saline filled and silicone gel filled implants. Saline implants have a silicone elastomer shell filled with sterile saline liquid. Silicone gel implants have a silicone shell filled with a viscous silicone gel.

 

 Types of implants

 Saline implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion[10] with the goal of being surgically placed via smaller incisions. These original devices had a high failure rate and were discontinued in the early 1970s [citation needed]. The current devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed).

Saline-filled implants are the most common implant used in the United States due to restrictions on silicone implants, but are rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy reconstruction, plastic surgeons believe that silicone gel implants are the superior device. In patients with more breast tissue, however, saline implants can look very similar to silicone gel.

 Silicone gel implants

Thomas Cronin and Frank Gerow, two Houston, Texas, plastic surgeons, developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961. The first woman was implanted in 1962.

  Silicone implant generations

Silicone implants are generally described in terms of five generations which segregates common characteristics of manufacturing techniques.

  • First generation

The Cronin-Gerow implants were made of a silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch on the posterior shell.[11] They were firm and had a “teardrop” anatomic shape.

  • Second generation

In response to surgeons’ requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner gel and thinner shells. These implants had a greater tendency to rupture and leak, or “bleed” silicone through the porous shell, and complications such as capsular contracture were also quite common. It was predominantly implants of this generation that were involved in the class action-lawsuits against Dow-Corning in the early 1990s. Another development in the 1970s was a polyurethane foam coating on the implant shell which was effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later discontinued due to concern of potential carcinogenic breakdown products from the polyurethane.[12] A review of the risk for cancer from TDA by the FDA later concluded that the risk was so small so as not to justify removal of the devices. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States. Second-generation implants also included various “double lumen” designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants due to their more complex design. The contemporary versions of these devices (”Becker Implants”) are used primarily for breast reconstruction.

  • Third & Fourth generation

compared to earlier devices. A variety of both round and tapered anatomic shapes are available. Anatomic shaped implants are uniformly textured to reduce rotation, while round devices are available in smooth or textured surfaces.

  • Fifth generation

Evaluation of “gummy bear” or high-cohesive, form-stable implants is in preliminary stages in the United States but enjoys wide use in the rest of the world. It is believed that the high degree of gel cohesion in these implants is likely to eliminate or significantly reduce the possibility of silicone migration. Early reports of these devices have shown excellent safety and efficacy.

Silicone implant crisis of early 1990s

Although silicone gel-filled breast implants were introduced into the US market decades prior, the FDA did not have a statutory basis to regulate most medical devices until the late 1970s. After a number of anecdotal reports surfaced alleging problems in patients with gel implants, the FDA asked for and reviewed hastily assembled data submitted by several implant manufacturers. They later concluded that the amount of data presented was not sufficient to prove safety but did not necessarily reflect any evidence of an associated risk between the devices and disease. In 1992, amid intense political pressure and media publicity, the FDA reclassified the devices as experimental and restricted silicone gel-filled breast implants to clinical trials, primarily for women needing reconstruction after mastectomy or breast deformity, or for women with implants that need to be replaced. Prior to the FDA’s restrictions on silicone gel-filled implants in 1992, approximately 97% of women who underwent breast implant surgery chose to have silicone gel-filled implants. In November 2006, the FDA reapproved silicone implants for cosmetic and reconstructive indications.

. In Canada, a similar series of events occurred where silicone gel-filled prostheses were restricted by Health Canada in 1992 prior to a limited reintroduction in 1999. A 2005 Canadian panel of experts reviewed the data and research again, and found no compelling reason to restrict access to the devices, and in October 2006, Health Canada removed the restrictions on the use of these implants No other countries in the world have any significant restrictions on access to silicone breast implants.

 Implant placement techniques

 Incision types

Breast implants for augmentation may be placed via various types of incisions:

  • Inframammary - an incision is placed below the breast in the infra-mammary fold (IMF). This incision is the most common approach and affords maximum access for dissection and placement of an implant. It is often the preferred technique for silicone gel implants due to the longer incisions required.
  • Periareolar - an incision is placed along the areolar border. This incision provides an optimal approach when adjustments to the IMF position or mastopexy (breast lift) procedures are planned. The incision is generally placed around the inferior half, or the medial half of the areola’s circumference. Larger silicone gel implants are difficult to place via this incision.
  • Transaxillary - an incision is placed in the armpit and the dissection tunnels medially. This approach allows implants to be placed with no visible scars on the breast. Transaxillary procedures can be performed with or without an endoscope (tiny lighted camera).
  • Transumbilical (TUBA) - a less common technique where an incision is placed in the navel and dissection tunnels superiorly. This approach enables implants to be placed with no visible scars on the breast, but makes appropriate dissection and implant placement more difficult. Transumbilical procedures may be performed bluntly or with an endoscope (tiny lighted camera) to assist dissection. This technique is not appropriate for placing silicone gel implants due to potential damage of the implant shell during blunt insertion.
  • Transabdominoplasty (TABA) - procedure similar to TUBA, where the implants are tunneled up from the abdomen into bluntly dissected pockets while a patient is simultaneously undergoing an abdominoplasty procedure.

 Implant pocket placement

The placement of implants is described in relation to the pectoralis major muscle.

  • Subglandular- implant between the breast tissue and the pectoralis muscle. This position closely resembles the plane of normal breast tissue and is felt by many to achieve the most aesthetic results. The subglandular position in patients with thin soft-tissue coverage is most likely to show ripples or wrinkles of the underlying implant. Capsular contracture rates are also slightly higher with this approach
  • Subfascial- the implant is placed in the subglandular position, but underneath the fascia of the pectoralis muscle. The benefits of this technique are debated, but proponents believe the thin vascularized fascia may help with coverage and sustaining positioning of the implant.
  • Subpectoral (”dual plane”) - the implant is placed underneath the pectoralis major muscle after releasing the inferior muscular attachments. As a result, the implant is partially beneath the pectoralis in the upper pole, while the lower half of the implant is in the subglandular plane. This is the most common technique in North America and achieves maximal upper implant coverage while allowing expansion of the lower pole. Capsular contracture rates have been lower after widespread adoption of this technique.
  • Submuscular- the implant is placed below the pectoralis without release of the inferior origin of the muscle. Total muscular coverage may be achieved by releasing the lateral chest wall muscles (seratus and/or pectoralis minor) and sewn to the pectoralis major. This technique is most commonly used for maximal coverage of implants used in breast reconstruction.

 Complications

 

Local complications that can occur with breast implants include post-operative bleeding (hematoma), fluid collections (seroma), surgical site infection, breast pain, alterations in nipple sensation, interference with breast feeding, visible wrinkling, asymmetric appearance, wound dehiscence (with potential implant exposure), thinning of the breast tissue, and synmastia (disruption of the natural plane between breasts).The most common reasons cited for reoperation after breast augmentation are capsular contracture and dissatisfaction with size or appearance.

Rupture

Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.

The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants “are not lifetime devices” and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation. Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.

Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture; according to implant makers, only 30% of ruptures are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [19] For that reason, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery and recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. . Other countries have not endorsed routine MRI screening, and taken the position that MRI be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.

In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study. [20] However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. MRI data from the US-FDA required “core” studies of contemporary implants has demonstrated low rupture rates (<2%) within the first 3-4 years after implantation for single lumen silicone implants, and will continue to be followed longitudinally to better characterize rupture rate.

The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of at between 8% to 15% at or around a decade.. This represented a 15-30% silent rupture risk for individual patients. The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less, at a median age of six years.

When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae  in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph glands in the armpit area).

The specific risk and treatment of extracapsular silicone gel is still controversial. Plastic surgeons agree that it is difficult to remove, but there is disagreement about the health effects.

Capsular contracture

Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma.Capsular contracture may happen again after this additional surgery.

Methods which have reduced capsular contracture include submuscular implant placement, using textured  or polyurethane-coated implants , limiting handling of the implants and skin contact prior to insertion  and irrigation with triple-antibiotic solutions.

Correction of capsular contracture may require surgical removal or release of the capsule or removal (and possible replacement) of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include external ultrasound , treatment with leukotriene pathway inhibitors (Accolate, Singulair) , and pulsed electromagnetic field therapy.

 Scarring and Hypotrophic Scarring

A common complication of breast implants is scarring, including hypotrophic scarring. Although scarring is a common complication of surgery, the 6-7% rate reported for augmentation patients by the two main manufacturers in the world, Allergan and Mentor,

 is a notable complication for a cosmetic procedure.

 Chronic Breast Pain and Changes in Nipple and Breast Sensation

Feeling in the nipple and breast can change after implant surgery. Changes include intense sensitivity, chronic breast pain, and no feeling in the nipple or breast for months or years after surgery.

In their booklets for patients, Allergan and Mentor report that within the first 3 years, between 2-8% of augmentation patients report moderate to severe chronic breast pain, an additional 1-2% report moderate to severe breast sensation changes, and 3-10% report moderate to severe nipple complications such as loss of sensation. These are similar for silicone gel or saline breast implants, but the longer-term data on saline implants indicates that chronic breast pain is reported by 17% of women within 5 years.

This altered sensation can be temporary or permanent and may affect sexual response or the ability to nurse a baby.

 Extrusion

Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin. According to the two main implant manufacturers, Allergan and Mentor, extrusion occurs for 1-2% of reconstruction patients, and is somewhat less common with augmentation patients.  Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.

 Necrosis

Necrosis, the death of tissue around the implant, requires surgery and may necessitate implant removal. According to studies by Inamed, necrosis occurs more frequently for silicone gel breast implant reconstruction patients (2%) than augmentation patients (less than 1%). A permanent scar may form.

 Systemic illness and disease

Since the early 1990s, scientific reviews have examined the possible relationship between silicone gel breast implants and systemic disease. The consensus of these is that there is no clear evidence of a causal link between the implantation of silicones and systemic illness.

Thousands of women have still claimed that they have become ill from their implants. Complaints include neurological and rheumatological problems.

As studies have followed women with implants for a longer period of time, more information has been made available to assess these issues. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of rheumatic symptoms then control groups.[35] A large study of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. The authors attributed this to possible differences in smoking rates.[36] Another large study of nearly 25,000 Canadian women with implants recently reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind. The study reported a high incidence of breast pain, and higher suicide rates in implant patients.

A 2001 study on silicone gel breast implants reported an increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. . However, this association was not repeated in a similar study based on a large group of Danish women, and the FDA concluded “the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants.”

Platinum

Platinum is a catalyst used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients.

In 2006, researchers published a controversial study that claimed to identify the previously undocumented presence of toxic platinum oxidative states in vivo. [41]. A letter from the editors of the publishing journal, Analytical Chemistry, subsequently expressed concern over the research’s experimental design and urged the journal’s readers to “use caution in evaluating the conclusions drawn in the paper.” [42]The FDA reviewed this study and the existing literature, concluding that the body of existing research did not support their findings, and that the platinum in new implants is likely not ionized and therefore would not represent a significant risk to women.

 Concerns with breast cancer screening and treatment in patients with breast implants

The presence of radio-opaque breast implants may interfere with the sensitivity of screening mammography. Specialized radiographic techniques where the implant is manually displaced (Eklund views) may improve this somewhat, but approximately 1/3 of the breast is still not adequately visualized with a resultant increase in false-negative mammograms.A number of studies looking at breast cancers in women with implants have found no significant difference in stage of disease at time of diagnosis, and prognosis appears to be similar in both groups with augmented patients not a higher risk for subsequent cancer recurrence or death. Conversely, the use of implants for reconstruction after mastectomy for breast cancer also appears not to have a negative affect on cancer-related mortality.

An observation that patients with implants are more often diagnosed with palpable tumors (but not larger ones) suggest that tumors of equal size may be more easily palpated in augmented patients, and this may compensate somewhat for the potential impairment of mammography. This palpability is due to thinning of the breast by compression, innately smaller breasts a priori, and that the implant serves as a base against which the mass may be differentiated.

The presence of a breast implant does not influence the ability for breast conservation (lumpectomy) surgery for women who subsequently develop breast cancer, and does not interfere with delivery of external beam radiation (XRT) treatments that may be required. Fibrosis of breast tissue after XRT is common and an increase in capsular contracture rates would be expected.

 Repair or revision surgery

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (reoperations) over the course of their lives. Reasons for reoperations include capsular contracture, wrinkling, asymmetry, rupture/deflation, implant malposition and other local complications. Reoperation rates are more frequent in breast reconstruction cases, particularly when patients have received XRT. A recent study found that 1 in 3 women getting breast implants for reconstruction needed a reoperation within five years, and about 1 in 8 women getting breast implants for augmentation needed a reoperation within five years.

It appears that reoperation rates can be improved by more carefully matching individual patients’ soft-tissue characteristics to the type and size of implants used. Using appropriate device selection and proper technique, reoperation rates at up to seven years follow up have been reported as low as 3% , as compared with the 20 percent reoperation rate at 3 years in the most recent Food and Drug Administration study.

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