Breast Augmentation Introduction



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Early

  1. Hematoma

  2. Seroma

  3. Infection

  4. Pain

  5. Pneumothorax


Late

  1. Asymmetry

  2. Breast pain

  3. Breast tissue atrophy

  4. Scars

  5. Altered sensation of the NAC

  6. Capsular contracture

  7. Implant related

    • displacement

    • rippling

    • noise

    • extrusion

    • rupture

    • calcification

    • palpability

    • visibility

  8. Human adjuvant disease


Hematoma

  • 0.5-3%

  • Pts with hematoma or seroma have a swollen, painful ecchymotic breast that is tender and firm to palpation

  • Early drainage is essential to avoid infection wound breakdown asymemetry or delayed capsular contracture

  • If require implant removed and pocket irrigated with Abs and implant replaced and ABS post op for a Week

  • Seromas are usually localised and non tender and self limiting but may rarely induce psuedobursa formation

  • Hematomas will increase infection and capsular contracture rates(86%)


Pneumothorax

  • Risk factor: Subpectoral dissection in thin patients


Seroma

  • Generally self limiting

  • More common with transaxillary approaches, excessive use of diathermy and concentrated antibiotic irrigation solutions.

  • U/S guided drainage if severe


Infection

  • 1-2%

  • Risk factors: surgical technique, comorbidities, breast reconstruction and implant replacements, transaxillary/transareolar incisions

  • 90% positive cultures in nipple – some cover it with adhesive during surgery

  • Acute infections usually present 5-14 d post op with warmth swelling and erythema

  • 45% may be salvaged by antibiotics although 68% of these will develop symptomatic capsular contracture

  • More serious infections may cause drainage and wound dehiscence. 7 cases of toxic shock syndrome

  • 66% are occur early – most due to staph aureus

  • late infection like staph epidermidis - chronic low grade periprosthetic infections. Usually results from secondary bacteraemia.

  • Start antibiotics immediately

  • if antibiotics don’t resolve the infection implant removed and replaced after a 3 month period

  • Removal of the implant may not be necessary, particularly if only skin is cellulitic or if a periareolar incision was used with initial surgery.

  • Implant salvage has been described (Yii PRS Mar 03) following breast reconstruction by washout, capsulectomy, implant exchange and post-op continuous saline/antibiotic irrigation. 9 out of 14 patients salvaged.

  • Salvage should not be attempted in cases of overwhelming infection or deficient soft-tissue coverage (Spear PRS 2004)


Pain

  • Immediate postop – more likely with subpectoral dissection

  • Late pain - most commonly related to contracture


Altered sensation of the NAC

  • Inadvertent injury to the 3rd 4th 5th lateral int costal nerves can lead to altered sensation of the NAC and is as a result of aggressive pocket dissection and extensive electrocoag at the lateral portion of the pocket- 15 % incidence

  • Usually transient

  • Reduced risk with submuscular pocket

  • Transaxillary can get neurapraxia of the intercostobrachial nerves that usually resolve


Skin Irritation

  • Transient erythema, edema, itching and a burning sensation in the skin of the breast are peculiar to polyurethane-coated implants and occur in 10% to 20% of patients.


Galactorrhea

  • Rare complication

  • transection or irritation of thoracic nerves by the surgery causing prolactin secretion

  • Treat with intercostal nerve block or bromocriptine


Asymmetry

  • In the form of volume, projection and lateral or vertical dimension

  • High riding implant can be treated with taping

  • If over dissection of the IMF taping or under wire used to allow adherence of the flap

  • May develop early (technical issue) or late (tissues stretching or implant failure)


Capsular contracture

Baker Classification

Baker Class III and IV generally considered as poor outcomes


Histology of capsule


  • The membrane consists of a thin inner layer of fibrocytes and histiocytes surrounded by a thick layer of relatively acellular collagen fiber bundles. The outermost layer is composed of loose connective tissue, whereas the middle layer is made up of densely packed collagen bundles lying parallel to each other.



  • Rubino (Ann Plast Surg 2001) described 5 layers in contracted capsules of textured implants :

    • I = inner surface

    • II = inner vascular layer (present only in contracted capsules)

    • IIIb = intermediate inner layer

    • IIIa = intermediate outer layer

    • IV = outer vascular layer

    • V = outer surface.

  • Histological differences textured vs smooth implants (Wyatt PRS 1998)

  1. Smooth

  1. Lining: The capsule adjacent to smooth-surfaced implants is lined with flattened mesothelial-like cells or contains no lining at all.

  2. Cells: relatively avascular and acellular

  3. Collagen: well-organized bundles of collagen fibers oriented parallel to the implant surface.

  1. Textured

  1. Lining: more often lined with synovial-like metaplasia and more likely to have villous hyperplasia

  2. Cells: A more pronounced foreign body response with increased amount of foreign material compared to smooth implant

  3. Collagen: multidirectional collagen fiber orientation

  • presence of synovial-like metaplasia at the lining of capsules in both the smooth and textured groups decreased with time

  • presence of a dense, collagenous architecture within smooth capsules increased with time;

  • decreased collagen over time with textured implant

  • Capsular calcification related to the duration of implantation (100% in 20 years) – unknown significance


Etiology

Remains unknown



Two theories implicate non-infectious stimuli to hypertrophic scar formation (hematoma, granuloma and hereditary factors) or infectious agents

  1. hypertrophic scar hypothesis

  • Myofibroblast are seen in the capsule - thought that a chronic low grade inflammatory foreign body reaction may lead to the release of peptide growth factor and thus prolong the inflammatory process leading to hypertrophic scar like formation

  1. Infectious hypothesis

  • Bacteria exist in two distinct phases, a free-floating or planktonic form and a sessile form that adheres to solid surfaces by means of a secreted exopolysaccharide, forming a biofilm.

  • This matrix provides protection to bacteria within the biofilm, increasing their resistance to both disinfectants and antibiotics

  • Implicated as a cause of chronic antibiotic-resistant and culture-negative inflammation around implants

  • biofilm on the outer surface of the implant, once established, may form a focus of irritation and chronic inflammation, leading to accelerated capsular contracture

  • Pajkos (PRS 2003) - positive cultures were obtained from either the capsule or the implant (or both) for 18 of the 19 contracted samples. Biofilm was demonstrated with scanning electron microscopy in the single culture-negative sample.

  • Biofilms are also detected in noncontracted capsules



Incidence

  • For saline implants, grade III or IV capsular contracture of 9% at 3 years and 10-11% at 5 years for augmentation patients.

  • 11% at 10years for textured silicone implants.


Risk Factors

  1. Hematoma

  2. Infection

  3. Reconstructive and secondary procedures

  4. Subglandular placement

  5. Smooth implant

  6. Silicone implant – gel bleed

  7. Duration of implantation


Preventing contracture

  1. Minimise risk of hematoma

  2. Minimise risk of infection

    1. Sterile surgical technique – avoid/minimise implant contact with skin

    2. Pocket irrigation with betadine

      1. Burkhardt PRS 1995 – Betadine irrigation reduces overall incidence of contracture by 85%

      2. Mentor advises against any contact with saline implant shell as may increase deflation rate (data actually for intraluminal betadine, other studies have shown no problems with external irrigation)

      3. Disadvantage: reduces wound tensile strength and is cytotoxic to fibroblasts (Lineaweaver 1985)

    3. Antibiotics

      1. Prophylactic benzylpenicillin and dicloxacillin administered intravenously 1 hour before surgery reduced number of positive cultures from dissected subglandular pockets from 79% to 7% with antibiotic prophylaxis

      2. intraluminal (inside implant) Abs have been used with steroids.

      3. Have been shown to reduce capsule but doubles implant failure rates.

      4. Adams PRS 2000 – showed that pocket irrigation with gentamicin 80mg and cephazolin 1gm did not cover Staph Epidermidis but adding 10% povidone-iodine covered it and all other common organisms.

  1. Steroids

    1. Initially described instilled into pocket with reduction in contracture rate but concerns rose about wound healing, thinning of skin flaps and subcutaneous tissue erosion with implant exposure

    2. Intraluminal steroids were then shown to have a significant decrease in capsular contracture

    3. Doses of >20mg of methyprednisolone led to 62% incidence of steroid related complications

  2. Cyclosporine A

    1. inhibition of the release of interleukin-1, which is a fibroblast proliferation factor that can be responsible for excessive collagen deposition.

    2. when added to the prosthesis shown to reduce capsule formation in rats

  3. Mitomycin C

  4. Vit E

    1. Oral ingestion for antiinflammatory effects

    2. Baker prescribes Vit E 1 wk pre op and continues for 2 yrs but unclear of effects. Rat model vit E shown to delay capsule

  5. Expansion exercises

    1. For saline implants, Hoeler described technique of forcibly moving prosthesis within the pocket to maintain the volume of the pocket.

    2. More than halves the contracture rate (Vinnik 58% to 28%, Barker 35% to 5%)


Managing the established capsule

Closed compression (Baker PRS 1976)

  • Goal is to hydraulically explode the scar capsule without fracturing the implant- manually squeezing the breast until audible pop heard

  • 66% success rate but high recurrence rate (80%)

  • External ultrasound has been used to prevent recurrence

  • Complications (10%) - hematoma, ruptured implant(may be as high as 50 %) gel migration, dumbbell deformity and incomplete rupture


Open capsulotomy

  • Once the capsule is entered it can be scored partially stripped or removed

  • recurrence of capsular firmness in 37% to 89% of patients.

  • General principle is to perform capsulectomy and change tissue planes if implant previously infected, otherwise do limited capsulotomy and replace in the same plane

  • Controversial what happens to capsule after removal of implant

  • Collis (PRS 2000) found that total capsulectomy for subglandular silicone breast implant capsular contracture results in a lower capsular recurrence than anterior disc capsulectomy. The pattern and risk of recurrence after total capsulectomy and exchange for a modern textured prosthesis appear to approach those following primary augmentation.


Implant related

Displacement

  • Early (technical) or late (steroid use, pectoralis muscle, closed capsulotomy)

  • If early treat with taping or external sutures


Noise

  • Inadequate air removal or underfilling



Rippling

  • Due to underfilling or traction

  • Underfilling occurs in saline implants and is seen in the upper pole

  • Traction is seen in textured implants and due to the implant’s pulling on the skin where the capsule is adherent to both implant and skin.



Deflation and rupture

Definitions

  • Bleed = normal process of diffusion of silicone oil out of semipermeable silicone shell into capsule

    • 3rd generation shells have a fluorinated shell that significantly reduces bleeding

  • Leak = an abnormal condition in which a small amount of silicone gel passes through a detectable small hole in the shell, resulting in a thin coating of gel, usually less than 0.5 mm thick, on the external surface of the shell.

  • Intracapsular rupture =an abnormal condition in which a major tear or disruption of the shell occurs such that a significant portion of the silicone gel lies outside the shell, although still confined within the [periprosthetic] capsule.

  • Extracapsular rupture=displacement of silicone gel from a ruptured implant through a tear in the [scar] capsule and into the adjacent tissues.

    • gel migration, silicone gel granulomas, and chronic disseminated granulomatous inflammation may result but rarely

Risk factors:

  1. underfilling (saline)

  2. age of implant

    • studies confirm diminishing strength of the silicone shell of breast implants with duration of implantation.

  3. implant type- second-generation implants worst

  4. intraluminal betadine, steroids, antibiotics

  5. contracture

  6. trauma

    • closed compression (saline)

    • mammography


Rupture Rates

  • Most studies for saline implants show 1% deflation/year (7% at 7 years)

  • Studies for silicone rupture are confusion as they include old generation implants

  • Metaanalysis of 9770 cases - overall failure rate of 42%, with failure rates of 30% at 5 years, 50% at 10 years, and 70% at 17 years (Marotta 1999)

  • 12-26% of gel-filled ruptures are extracapsular

  • Rates under reported as most are silent and detected at time of mammography or implant exchange

  • Estimated rupture rate 50% at 15 years – they recommended thorough examination of any presenting implant older than 10 years. (Beekman PRS 1997)

  • Rupture rate of modern silicone implant estimated at <10% at 5 years


Diagnosis

  • methods

  1. physical examination

    1. detecting saline rupture easier than gel rupture

    2. Dowden (PRS 1993) squeeze test: identify free-flowing gel within an implant capsule by squeezing intracapsular free gel through a constricted portion of the pocket. The test is limited to patients who do not have contracted capsules. Claims it is more accurate than mammogram

  2. endoscopic surgical exploration

  3. open surgical exploration

  4. mammography

    1. Breast augmentation may interfere with the interpretation of mammography examinations because implants are radio-opaque

    2. limitations – posterior one-fourth to one-third of the implant is routinely excluded and it primarily assesses morphology of the implant and therefore cannot detect intracapsular ruptures.

    3. Signs of extracapsular implant rupture include a large contour bulge or opaque axillary nodes containing silicone.

  5. Ultrasonography

    1. Sensitivity 70% - reduced by capsular contracture, operator dependant

  6. magnetic resonance imaging (MRI).

    1. Most accurate imaging modality

    2. Increased sensitivity with use of breast coils (95-100%)



Systemic Disease

  1. Tumorigenesis

    1. Concern about Oppenheimer effect - any smooth-surfaced material implanted in the peritoneum of rats will induce sarcomatous changes, but a roughsurfaced implant will not.

    2. Large linkage, case-control and epidemiologic studies have failed to find an association between implants and breast cancer risk.

    3. Silicone gel induced plasma cell tumors noted in mice, but multiple myeloma not increased

  2. Autoimmune disorders

    1. Early case reports of associations with progressive systemic sclerosis, scleroderma, rheumatoid arthritis, lupus erythematosus etc

    2. Blood silicone levels are elevated among women with breast implants compared with age-matched, nonaugmented controls. This is a universal finding in women with silicone implants and not an indication of implant leakage. No association between these levels and connective tissue disease.

  • Proposed mech include genetic predisposition with HLA DR-7 and DR-53 genes and conversion of silicone into silica stimulating collagen synthesis

  • Institute of Medicine of the National Academies of Science final report in 1999 - there is no definitive evidence linking breast implants to cancer, immunological diseases, neurological problems, or other systemic diseases. Women with breast implants are no more likely than other women to develop these illnesses.

  • European Committee on Quality Assurance and Medical Devices in Plastic Surgery (1998) consensus declaration :

  1. Updated studies continue to show that silicone gel-filled implants do not cause cancer.

  2. There are conclusive scientific data that silicone gel-filled breast implants do not cause any autoimmune or connective tissue diseases.

  3. There is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease, or a ‘new silicone disease’ exist.

  4. There is a normal foreign-body reaction to every implant, but this is not immune disease.

  5. Silicone implants do not adversely affect pregnancy or breast feeding or the health of breastfed children.

  6. Laboratory tests for the detection of silicone are of no clinical value.

  • Janowsky (NEJM 2000) – metaanalysis of 20 major studies found no association between implant and connective tissue or rheumatic disease



Interference with breast cancer detection

  • 40% of glandular tissue is obscured by the subglandular implant on conventional mammography (20% for submuscular)

  • Both saline and silicone implants show same radiodensities on mammography

  • Periprosthetic calcifications do not appear to mimic cancer or increase the chances of having a false-positive mammogram but calcium deposits may affect the ability of mammography to detect lesions close to the capsule.

  • Eklund’s displacement views indicated for augmented patients.

    1. greatly increase the amount of breast tissue that can be seen on mammogram in the presence of an implant.

    2. consists of manually pushing the implant back toward the chest wall and selectively compressing the breast after pulling it forwards

    3. Compared with standard views, which revealed 56% and 75% of breast tissue in subglandular and submuscular implants respectively, the Eklund technique successfully imaged 64% and 85% of breast tissue.

  • Increased capsular contracture and subglandular placement make viewing harder. Size of implant is not a factor

  • 2 recent studies of breast cancer following augmentation mammoplasty suggest breast cancer diagnosis may be delayed in women with augmentation.

    1. Skinner et al (Ann Surg Oncol. 2001) found that mammography was less sensitive for women with augmentation (N = 99) compared with women without augmentation (66.3% vs 94.6%) and that women with augmentation were more likely to be diagnosed with palpable tumors (83% vs 59%), invasive carcinoma (82% vs 72%), and to have nodal involvement (48% vs 36%).

    2. Brinton et al (Cancer Causes Control. 2000) found women with breast implants (N = 78) tended to have later-stage disease compared with women without augmentation (35% vs 17% with regional or distant disease); however, this difference was not statistically significant.

  • General consensus is that augmentation will reduce sensitivity but does not lead to worse tumor characteristics at diagnosis

  • Miglioretti et al (Effect of breast augmentation on the accuracy of mammography and cancer characteristics JAMA Jan 2004)- Among asymptomatic women, the sensitivity of screening mammography based on the final assessment was lower in women with breast augmentation vs women without (45.0% vs 66.8%; P =.008), and specificity was slightly higher in women with augmentation (97.7%vs 96.7%; P<.001). Among symptomatic women, both sensitivity and specificity were lower for women with augmentation compared with women without but these differences were not significant. Tumors were of similar stage, size, estrogen-receptor status, and nodal status but tended to be lower grade (P =.052) for women with breast augmentation vs without

  • Among symptomatic women, women with augmentation had tumors with better prognostic characteristics, including smaller size, lower grade, and estrogen-receptor positive status. This suggests it may be easier to palpate breast masses in women with breast implants given their lower native breast volume or because breast implants provide a firm platform to palpate against. In addition, women with augmentation may be more breast aware or body conscious and hence seek medical care more quickly for breast changes or symptoms.

  • MRI good alternative but low specificity


Mentor Augmentation Patients 3-Year Complication Rates (submission to FDA)

Augmentation patients experienced the following problems within the first 3 years of receiving their implants:



21%

Wrinkled appearance of the breast

13%

Needed another operation

10%

Loss of nipple sensation

9%

Capsular contracture (hardening of breast)

8%

Implant removal

7%

Asymmetry (breasts look different from each other)

5%

Intense, painful nipple sensation

5%

Breast pain

3%

Implant leaks/deflates

2%

Implant can be felt

2%

Infection

2%

Sagging

2%

Scarring complications

2%

Hematoma (blood collects around the implant)


Inamed Augmentation Patients 3-Year and 5-Year Complication Rates

Augmentation patients experienced the following complications during the first three years and first five years after surgery.



3-Year

5-Year

 

21%

26%

Needed another operation

16%

17%

Breast pain

11%

14%

Wrinkled appearance of breast

10%

12%

Asymmetry (breasts look different from each other)

9%

12%

Implant can be felt or seen

8%

12%

Implant replacement/removal for any reason

9%

11%

Capsular contracture (hardening of breast)

9%

10%

Intense, painful nipple sensation

8%

10%

Loss of nipple sensation

8%

9%

Implant is in a bad position

7%

8%

Intense skin sensation

6%

7%

Scarring complications

5%

7%

Implant leaks/deflates

3%

3%

Irritation/inflammation

3%

3%

Seroma (watery portion of blood collects around implant or incision)

2%

2%

Hematoma (blood collects around the implant)

2%

2%

Skin rash

1%

2%

Calcium deposits form around implant

1%

1%

Delayed wound healing

<1%

1%

Infection

 

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