Clinical Practice Guideline

for

BREAST IMPLANTS

Developed for the

Aerospace Medical Association

by their constituent organization

American Society of Aerospace Medicine Specialists

 

Overview: Breast implants were developed and first marketed in the 1960s and are performed both for breast enlargement and for breast reconstruction in women who have undergone a mastectomy for breast cancer.  Breast augmentation (also called augmentation mammoplasty) is the most popular aesthetic surgery procedure performed in the United States, with almost 350,000 procedures performed in 2007, up 6% from 2006 and up 64% from 2000.

 

There are two primary types of implants: saline-filled and silicone gel-filled.  Both silicone and saline were available in the United States until 1992, when the FDA called for a moratorium on silicone implants until their safety could be established.  The safety concerns have been essentially answered and the ban on silicone implants was lifted in November 2006.  The concerns with silicone implants surrounded issues related to implant rupture and possible subsequent connective tissue problems.  Implant ruptures do occur and can be prevented with the choice of implant and surgical technique, but are more common with increasing age of the implant.  In addition, analysis of several large studies of women with silicone breast implants, or with silicone injections, has failed to demonstrate a significantly increased risk of any connective tissue disease or other autoimmune or rheumatic conditions.  In some cases, there can be a foreign body reaction to extruded silicone leading to supraclavicular lymphadenopathy that can cause concern about the possibility of breast cancer.

 

Breast augmentation is usually accomplished through a discrete incision placed either around the areola, at the inframammary fold, or in the axilla.  Regardless of the approach or the type of implant, the goal is to restore a normal position of the breast structures in relation to the inframammary fold.  For most surgeons performing these procedures, the inframammary approach offers the greatest visualization of the critical operative tissues and results in the least damage to normal tissue.

 

Depending on the type of implant, the shell is either pre-filled with a fixed volume of saline or silicone, or saline-filled through a valve intraoperatively.  Some allow for volume adjustments after surgery.  The two basic placements for implants are subglandular and submuscular.  Subglandular implants are placed directly under the natural breast tissue, typically through an inframammary or axillary incision.  An inframammary incision is normally used for submuscular implants because it gives the best access to the pectoralis major.  Part of the pectoralis is cut at the sternal origin, and the implant is placed underneath the muscle.  Submuscular implants are less palpable; however, recovery time is longer, postoperative pain may be more severe, and reoperation is more difficult.  Most women do not notice a decrease in pectoralis strength, although some note a slight decrease, which is typically not functionally significant.

 

Post-operative and cosmetic complications include breast asymmetry, inflammation, pain, necrosis, changes in nipple sensation, infection, scarring, hematoma, skin dimpling and capsular contracture.  Approximately 20% of women with breast implants have some type of problem post-operatively that may or may not result in a reoperation.  Many of the common problems that the surgeons encounter are ultimately related to asymmetries in breast volume, contour, and position of the breast or nipple-areolar complex.  Causes of implant rupture include trauma, overcompression of the breast, manufacturing defects, and deterioration of the implant shell.  A recent large European study concludes that up to 25% of patients suffer chronic pain (described as “persisting continuous or intermittent pain for more than 3 months after surgery”) after breast augmentation (Air Force plastic surgeons are not seeing chronic pain rates this high).  Recent studies have identified several independent risk factors for surgical site infections and newer reviews recommend antibiotic prophylaxis for procedures involving placement of prosthetic material such as saline implants and any tissue expanders.

 

Aeromedical Concerns: The main risk of breast implants in the aviation environment is rupture or shifting due to compression from high G flight, egress, ejection or life support equipment.  This could cause pain and/or distraction during flight (these complications have not been documented among female military aviators).  Ambient pressure effects should be negligible because this is a closed fluid or gel device without trapped gas.  One in-vitro study showed insignificant bubble formation in both silicone and saline implants at an altitude of 30,000 feet immediately following prolonged hyperbaric exposure.  Implant volumes were slightly increased, but none ruptured and bubbles resolved spontaneously.  Post-operative complications may result in prolonged grounding and long-term health effects are not fully known.

 

Medical Work-up: Required documentation includes the clinical indication for the procedure, operative complications (if any), post-operative satisfaction, and a statement addressing the ability to wear life support equipment (particularly for military aircrew).  There needs to be assurance that the surgical sites are well healed and a consultation note from the operative surgeon is also required.

 

Aeromedical Disposition:

 

Air Force: According to AFI 48-123, V3, A4.17.1.22., “silicone implants, injections, or saline inflated implants in breasts for cosmetic purposes” is disqualifying for all classes of flying in the US Air Force.  Waiver potential is good if there are no significant postoperative complications.

 

Army: Breast implant surgery is not mentioned as disqualifying in AR 40-501 or the Army Aeromedical Policy Letters.  The theoretical concerns of problems with high G flight and ejection seat forces are not issues in Army aviation.

 

Navy: Not considered disqualifying provided a minimum of six weeks has elapsed since the surgery.

 

Civilian: In the civilian sector there are no particular policies as regards breast implants.  The airman should report the surgical procedure as they are asked to report any visit to a health care individual.  The only issue that would arise would be if there were complications as a result of the surgery.  The airman should be grounded until the surgical site has healed and they are cleared for routine duties.

 

Waiver Experience:

 

Air Force: AIMWTS review revealed a total of 115 submitted cases for breast implants or breast augmentation.  All but 6 cases were given a waiver.  Four of the disqualified cases were for other medical problems, one for an unsatisfactory ARMA, and the sixth was an initial FC III case that had also had LASIK with the pre-operative refractive error exceeding acceptable standards.  Twenty-three of the cases do not state the type of implant; of the remaining, 77 were saline implants and the other 15 were silicone implants.  Two of the cases were secondary to surgery for breast cancer and one other was for bilateral mastectomies due to a very strong family history of breast cancer and a positive genetic predisposition.  There were 7 FC I cases, 20 FC II cases and 88 FC III cases.

 

Army: Given that breast implants are not considered disqualifying in AR 40-501, there were only ten reported cases found in the Aeromedical Epidemiological Data Repository.

 

Navy: Not available at this time.

 

Civilian: There are no numbers kept for this procedure at the current time.

 

ICD-9 Code for Breast Implants

85.5

Augmentation Mammoplasty

85.54

Bilateral Breast Implant

85.6

Mastopexy

611.79

Other signs and symptoms in the breast

V50

Elective Surgery for purpose other than remedying health status

V50.1

Other Plastic Surgery for unacceptable cosmetic appearance

V52.4

Fitting and adjustment of breast prosthesis

 

 

 

 

 

 

 

 

 

 

References:

 

Lalani T, Levin S and Sexton DJ.  Breast implant infections.  UpToDate.  Online version 17.1 January 2009.

 

Spear SL, Parikh PM, and Goldstein JA.  History of Breast Implants and the Food and Drug Administration.  Clin Plastic Surg, 2009; 36:15-21.

 

Pusic AL, Reavey PL, Klassen AF, et al.  Measuring Patient Outcomes in Breast Augmentation: Introducing the BREAST-Q© Augmentation Module.  Clin Plastic Surg, 2009; 36:23-32.

 

Hölmich LR, Friis S, Fryzek JP, et al.  Incidence of Silicone Breast Implant Rupture.  Arch Surg, 2003; 138:801-06.

 

Janowsky EC, Kupper LL and Hulka BS.  Meta-Analysis of the Relation Between Silicone Breast Implants and the Risk of Connective Tissue Diseases.  N Engl J Med, 2000; 342:781-90.

 

Shipchandler TZ, Lorenz RR, McMahon J, and Tubbs R.  Supraclavicular Lymphadenopathy Due to Silicone Breast Implants.  Arch Otolaryngol Head Neck Surg, 2007; 133:830-2.

 

Burns, JL and Blackwell SJ.  Plastic Surgery in Ch. 73 of Sabiston’s Textbook of Surgery, Saunders Elsevier, 2007.

 

Teitelbaum S.  The Inframammary Approach to Breast Augmentation.  Clin Plastic Surg, 2009; 36:33-43.

 

Nahabedian MY and Patel K.  Management of Common and Uncommon Problems after Primary Breast Augmentation.   Clin Plastic Surg, 2009; 36: 127-38.

 

van Elk N, Steegers MA van der Weij L, et al.  Chronic pain in women after breast augmentation: Prevalence, predictive factors and quality of life.  Eur J Pain, 2009; 13:660-61.

 

Olsen MA, Lefta M, Dietz JR, et al.  Risk Factors for Surgical Site Infection after Major Breast Operation.  J Am Coll Surg, 2008; 207:326-35.

 

Treatment Guidelines from the Medical Letter.  Antimicrobial Prophylaxis for Surgery.  Vol. 7 (Issue 82), June 2009.

 

Vann RD, et al.  Mammary implants, diving and altitude exposure, Plastic and Reconstructive Surgery, 1988; 81(2):  200-203.

 

 

 

Prepared by Dr. Dan Van Syoc

11/10/10