Breast implant

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A breast implant is a prosthesis used to alter the size and shape of a woman's breasts (known as breast augmentation, breast enlargement, mammoplasty enlargement, augmentation mammoplasty or the common slang term boob job) for cosmetic reasons, to reconstruct the breast (e.g. after a mastectomy or to correct congenital chest wall deformities), or as an aspect of male-to-female sex reassignment surgery. Pectoral implants are a related device used in cosmetic and reconstructive procedures of the male chest wall. A breast tissue expander is a temporary breast implant used during staged breast reconstruction procedures. According to the American Society of Plastic Surgeons, breast augmentation is the most commonly performed cosmetic surgical procedure in the United States. According to data collected by the American Society of Plastic Surgery, in 2007, 307,230 breast augmentation procedures were performed in the U.S., a 12% decrease compared to the previous year. This decrease has been associated with the financial challenges posed by a struggling economy. Despite the decrease, however, breast augmentation surgeries remained as the number one surgical cosmetic procedure performed in the U.S.

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. Several alternative types of breast implants had been developed, such as polypropylene string or soy oil, but these are no longer manufactured.

Contents

Indications

Breast implants are used primarily for:

  • primary reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality such as the tuberous breast deformity)
  • revision-reconstruction (revision surgery to correct or improve the result of an original breast reconstruction surgery)
  • primary augmentation (to increase breast size for cosmetic reasons)
  • revision-augmentation (revision surgery to correct or improve the result of an original breast augmentation surgery)

Types of implants

Saline implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion[1] with the goal of being surgically placed via smaller incisions. Current saline devices are manufactured with thicker, room temperature vulcanized (RTV) shells than earlier generations of devices. These shells are made of a silicone elastomer and the implants are filled with salt water (saline) 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). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have higher failure rates in vivo.[2]

Saline-filled implants were most common implant used in the United States during the 1990s due to restrictions that existed on silicone implants, but were 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 to be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy breast reconstruction, silicone gel implants are considered as superior. In patients with more breast tissue in whom submuscular implant placement is used, 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 implants are generally described in terms of five generations which segregate common characteristics of manufacturing techniques.

First generation

The Cronin-Gerow implants were made of a tear drop shaped silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch (to reduce rotation of the implant) on the posterior shell.[3]

Second generation

In response to surgeons' requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner, less cohesive gels and thinner shells. These implants had a greater tendency to rupture or "gel bleed" silicone through an intact implant shell, and complications such as capsular contracture were quite common. It was predominantly implants of this generation that were involved in the American class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s.

Another development in the 1970s was a polyurethane foam coating on the implant shell which was very effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later briefly discontinued due to concern of potential carcinogenic breakdown products from the polyurethane.[4] 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 recommending explantation of the devices from individual patients. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States.[5] Second-generation implants also saw the introduction of 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

Third & fourth generation implants, from the mid 1980s, represented sequential advances in manufacturing principles with elastomer-coated shells to decrease gel bleed, and are filled with thicker, more cohesive gel. The increased cohesion of the gel filler reduced potential leakage of the gel compared to earlier devices and the more substantial shell improved durability as compared to 2nd generation implants. A variety of both round and tapered anatomic shapes are available from different implants in this group. The anatomic or shaped implants are uniformly impregnated with a textured surface to reduce rotation, while round devices are available in both smooth or textured surfaces.

Fifth generation

Evaluation of "gummy bear" or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been widely used since the mid 1990s in other countries. The semi-solid gel in these type of implants largely eliminates the possibility of silicone migration. Studies of these devices have shown significant potential improvements in safety and efficacy over the older implants with low rates of capsular contracture and rupture. [6][7][8]

Procedure

The surgical procedure for breast augmentation takes approximately one to two hours. Variations in the procedure include the incision type, implant material, and implant pocket placement.

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 precise dissection and placement of an implant. It is often the preferred technique for silicone gel implants due to the longer incisions required. This method can leave slightly more visible scars in smaller breasts which don't drape over the IMF. In addition, the scar may heal thicker.
  • 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. Silicone gel implants can be difficult to place via this incision due to the length of incision required (~ 5 cm) for access. As the scars from this method occur on the edge of the areola, they are often less visible than scars from inframammary incisions in women with lighter areolar pigment. There is a higher incidence of capsular contracture with this technique.
  • 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 and is more likely to consistently achieve symmetry of the inferior implant position. Revisions of transaxillary-placed implants may require inframammary or periareolar incisions (but not always). Transaxillary procedures can be performed with or without an endoscope.
  • Transumbilical (TUBA)[9] - 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. In that regard, it is pertinent that a published medical journal report [10] analyzed a consecutive series of more than 1300 TUBA cases done by a single surgeon over a 15 year span, with no instance of incorrect implant placement. Transumbilical procedures are performed bluntly, with or without an endoscope (tiny lighted video camera) to assist dissection. This technique is not appropriate for placing silicone gel implants due to potential damage of the implant shell if attempting insertion through the small 2 cm incision in the navel, and as those implants are pre-filled they cannot be passed through that incision.
  • Transabdominoplasty (TABA)[11] - 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.
  • Areolar Vertical Approach (AVA)[12] - the technique created by Dr. Lejour and developed by Dr. Van Thienen, is a very similar approach to the periareolar as the insicion is the same, but leaves a more extended submuscular pocket for the Silicon Gel Implants, through the transglandular sectione to the top pectoral fascia. The cavity is drained after being washed with Saline solution before the implants are placed. This technique developed in Argentina was proved to have excelent results even after numerous long term surgeries.

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 more likely to show ripples or wrinkles of the underlying implant. Capsular contracture rates may also be slightly higher with this approach.
  • Subfascial [13] - the implant is placed in the subglandular position, but underneath the fascia of the pectoralis muscle. The benefits of this technique are debated,[14] but proponents believe the fascial layer of tissue may help with coverage and sustaining positioning of the implant.
  • Subpectoral ("dual plane")[15] - 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. Animation or movement of the implants in the sub pectoral plane can be excessive to some patients.
  • 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 (serratus 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.

Recovery

Depending on the level of activity required, patients are generally able to resume normal activity in approximately one week's time. Women who have their implants placed underneath the muscle (submuscular placement) will generally have a longer recovery time and experience slightly more pain due to the muscle being cut during surgery. Exercise and strenuous physical activity will often need to be avoided for up to six weeks.

During initial recovery arm movement is encouraged to help lessen the discomfort. Pain catheters have been shown to be safe and effective. [16] [17] Scars from a breast augmentation surgery will last six weeks or longer and usually begin to fade several months after surgery.

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 (re-operations) over the course of their lives. Breast implants do not last forever. According to studies conducted by implant companies for the U.S. FDA, they sometimes only last a few years. Most common indications for re-operations have included major or minor complications, capsular contracture treatment, and replacement of ruptured/deflated implants.[18] Re-operation rates are predictably more frequent in breast reconstruction cases due to the dramatic changes in the soft-tissue envelope and anatomical breast borders after mastectomy, particularly when patients have received adjuvant XRT.[18] Breast cancer patients also frequently undergo staged procedures for reconstruction of the nipple-areola complex (NAC) and symmetry procedures on the opposite breast.

It appears that re-operation rates in cosmetic cases 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, re-operation rates at up to seven years followup have been reported as low as 3%,[19][20] as compared with the 20 percent re-operation rate at 3 years in the most recent Food and Drug Administration study.

Complications

Surgeries involving breast implants, whether for cosmetic or reconstructive surgery, carry risk common to many types of surgery. These include adverse reactions to anesthesia, post-operative bleeding (hematoma) or fluid collection (seroma), surgical site infection or breakdown, breast pain or alterations in sensation [21][22][23] , unfavorable scarring (6-7%) [21][22], interference with breast feeding, visible wrinkling, asymmetry, thinning of the breast tissue, and symmastia (disruption of the natural plane between breasts which is sometimes referred to as 'bread loafing'). Complications and reoperations related to surgeries with breast implants or tissue expanders can add significant long term costs to patients and health care systems.

Specific complications to indwelling breast implants that have received notable attention involve surveillance and treatment for implant rupture and the phenomena of capsular contracture.

Rupture

Breast implants can potentially remain intact for decades in the body, but all such devices will fail at some point. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 10 years for augmentation patients.[24] Among the suspected mechanisms for rupture are damage during implantation or other procedures, degradation of the implant shell, blunt or penetrating chest trauma, and in rare instances from the pressure of traditional mammograms.[18]

The age and design of the implant are the most important factors in rupture, but estimating ruptures rates of more contemporary devices has been difficult, as most previous reports[25] mixed heterogeneous groups of devices in non-randomized populations. 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 an implant at between 8% to 15% at or around a decade (or 15-30% of patients).[26][27][28]. In 2009, patient's followed in one arm of the core FDA clinical trials for primary breast augmentation reported rupture rates of 1.1% after six years followup [29]

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.[30]

It has been suggested that clinical exams alone are inadequate to evaluate suspected rupture after a study reported that only 30% of ruptures in asymptomatic patients are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [31] The US-FDA has recommended that MRIs be considered to screen for silent rupture starting at three years after implantation and then every two years thereafter.[21] Other countries have not endorsed routine MRI screening, and have taken the position that MRI should be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.

When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the 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 [32] in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy [33] (enlarged lymph glands in the armpit area).[34] The specific risk and treatment of extracapsular silicone gel is still controversial.

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.

Methods which have reduced capsular contracture include submuscular implant placement, using textured[35][36] or polyurethane-coated implants,[37] limiting handling of the implants and skin contact prior to insertion[38] and irrigation with triple-antibiotic solutions.[39]

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 massage, external ultrasound,[40] treatment with leukotriene pathway inhibitors (Accolate, Singulair),[41][42] and pulsed electromagnetic field therapy.[43]

Cancer screening

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.[44] 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.[45][46] Conversely, the use of implants for reconstruction after mastectomy for breast cancer also appears not to have a negative effect on cancer-related mortality.[47]

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.[37] 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.[48]

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.[49] Fibrosis of breast tissue after XRT is common and an increase in capsular contracture rates would be expected.

Breast implant manufacturers

  • Allergan- formerly Mcghan Medical & Inamed Corp.
  • Mentor Corporation - a subsidiary of Johnson and Johnson

References

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  49. SChwartz GF, et al. (2006). "Consensus Conference on Breast Conservation". JACAS 203 (2): 198–207. doi:10.1016/j.jamcollsurg.2006.04.009. PMID 16864033.

External links

International health ministry links

General breast implant links

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*Some information provided in whole or in part by http://en.wikipedia.org/

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