BREAST IMPLANTS

Whether you are undergoing augmentation or reconstruction, be aware that breast implantation may not be a one time surgery. You are likely to need additional surgery and doctor visits over the course of your life.
Breast implants are not considered lifetime devices. You will likely undergo implant removal with or without replacement over the course of your life.
Many of the changes to your breast following implantation are irreversible (cannot be undone). If you later choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast.
Breast implants may affect your ability to produce milk for breast feeding. Also, breast implants will not prevent your breast from sagging after pregnancy.
With breast implants, routine screening mammography will be more difficult, and you will need to have additional views, which means more time and radiation.

• Who is Not Eligible for Breast Implants?
Implants are contraindicated for women with:
• Existing malignant or pre-malignant cancer of your breast without adequate treatment.
• Active infection anywhere in your body.
• Augmentation in women who are currently pregnant or nursing.

• What are Contraindications, Warnings, and Precautions for You to Consider ?
• Placement of drugs/substances inside the implant other than sterile saline.
• Any contact of the implant with povidone-iodine (betadine).
• Injection through implant shell.
• Alteration of the implant.
• Stacking of implants: more than one implant per breast per breast pocket.

• Safety and efficacy have not yet been established in patients with the following conditions:
• Autoimmune diseases such as lupus and scleroderma
• All conditions that impede the formation of scars and blood clotting
• Immunodeficiency (e.g. because of immunosuppressant therapy)
• Poor blood flow in breast tissue

• Others considerations:
• Pre-implantation Mammography - You may wish to undergo a preoperative mammogram and another one 6 months to one year after implantation to establish a baseline.
• Interference with Mammography - The implant may interfere with finding breast cancer during mammography and also may make it difficult to perform mammography. Therefore, it is essential that you tell your mammography technologist that you have an implant before the procedure. The technologist can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because the breast is squeezed during mammography, it is possible for an implant to rupture during the procedure. More x-ray views are necessary with these special techniques; therefore, women with breast implants will receive more radiation. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays.

• Distinguishing the Implant from Breast Tissue during Breast Self-Examination
You should perform breast self-examination monthly on your implanted breast. In order to do this effectively, you should ask your surgeon to help you distinguish the implant from your breast tissue. Any new lumps or suspicious lesions (sores) should be evaluated with a biopsy. If a biopsy is performed, care must be taken to avoid puncturing the implant.
• Capsule Procedures - You should be aware that closed capsulotomy, the practice of forcible squeezing or pressing on the fibrous capsule around the implant to break the scar capsule is not recommended as this may result in breakage of the implant.

• What Are The Breast Implant Complications?
• Deflation/Rupture: Breast implants deflate when the saline solution either through an unsealed or damaged valve, or through a break in the implant shell. Implant deflation can occur immediately or progressively over a period of days and is noticed by loss of size or shape of the implant. Some implants deflate (or rupture) in the first few months after being implanted and some deflate after several years. Causes of deflation include damage by surgical instruments during surgery, overfilling or underfilling of the implant with saline solution, capsular contracture, closed capsulotomy, stresses such as trauma or intense physical manipulation, excessive compression during mammographic imaging, umbilical incision placement, and unknown/unexplained reasons. You should also be aware that the breast implant may wear out over time and deflate/rupture. Deflated implants necessitate additional surgery to remove and to possibly replace the implant. Silicone gel implants do not deflate because the silicone gel used is very cohesive. Therefore, even if the shell ruptures, the implant is not going to deflate.
• Capsular Contracture: The scar tissue or capsule that normally forms around the implant may tighten and squeeze the implant and is called capsular contracture. Capsular contracture is more common following infection, hematoma, and seroma. It is also more common with subglandular placement. Symptoms range from firmness and mild discomfort, to pain, distortion, palpability of the implant, and/or displacement of the implant. Additional surgery is needed in cases where pain and/or firmness is severe. This surgery ranges from removal of the implant capsule tissue to removal and possibly replacement of the implant itself. Capsular contracture may happen again after these additional surgeries.
• Pain: Pain of varying intensity and duration may occur and persist following breast implant surgery. In addition, improper size, placement, surgical technique, or capsular contracture may result in pain associated with nerve entrapment or interference with muscle motion. You should tell your doctor about severe pain.
• Additional Surgeries: Women should understand there is a high chance they will need to have additional surgery at some point to replace or remove the implant. Also, problems such as deflation, capsular contracture, infection, shifting, and calcium deposits can require removal of the implants. Many women decide to have the implants replaced, but some women do not. Those who do not may have cosmetically unacceptable dimpling and/or puckering of the breast following removal of the implant.
• Dissatisfaction with Cosmetic Results: Dissatisfying results such as wrinkling, asymmetry implant displacement (shifting), incorrect size, unanticipated shape, implant palpability, scar deformity, hypertrophic (irregular, raised scar) scarring, and/or sloshing may occur. Careful surgical planning and technique can minimize but not always prevent such results.
• Infection: Infection can occur with any surgery. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with an implant present are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed, and another implant may be placed after the infection is resolved. In rare instances, Toxic Shock has been noted in women after breast implant surgery, and it is a life-threatening condition. Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, and/or sunburn-like rash. A doctor should be seen immediately for diagnosis and treatment.
• Hématoma/ Séroma: Hematoma is a collection of blood inside a body cavity, and a seroma is a collection of the watery portion of the blood (in this case, around the implant or around the incision). Postoperative hematoma and seroma may contribute to infection and/or capsular contracture. Swelling, pain, and bruising may result. If a hematoma occurs, it will usually be soon after surgery, however this can also occur at any time after injury to the breast. While the body absorbs small hematomas and seromas, large ones will require the placement of surgical drains for proper healing. A small scar can result from surgical draining. Implant deflation/rupture can occur from surgical draining if damage to the implant occurs during the draining procedure.
• Changes in Nipple and Breast Sensation: Feeling in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense sensitivity to no feeling in the nipple or breast following surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby (See the paragraph on breast feeding below).
• Breast Feeding: With respect to the ability to successfully breast feed after breast implantation, one study reported up to 64% of women with implants who were unable to breast feed compared to 7% without implants. The periareolar incision site may significantly reduce the ability to successfully breast feed.
• Calcium Deposits in the Tissue Around the Implant: Deposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery to biopsy and/or removal of the implant to distinguish them from cancer.
• Delayed Wound Healing: In some cases, the incision site fails to heal normally.
• Extrusion: Unstable or compromised tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.
• Necrosis: Necrosis is the formation of dead tissue around the implant. This may prevent wound healing and require surgical correction and/or implant removal. Permanent scar deformity may occur following necrosis. Factors associated with increased necrosis include infection, use of steroids in the surgical pocket, smoking, chemotherapy/ radiation, and excessive heat or cold therapy.
• Breast Tissue Atrophy/Chest Wall Deformity: The pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.
• Connective Tissue Disease: Concern over the association of breast implants to the development of autoimmune or connective tissue diseases, such as lupus, scleroderma, or rheumatoid arthritis, was raised because of cases reported in the literature with small numbers of women with implants. A review of several large epidemiological studies of women with and without implants indicates that these diseases are no more common in women with implants than those in women without implants. However, a lot of women with breast implants believe that their implants caused a connective tissue disease.
• Cancer: Published studies indicate that breast cancer is no more common in women with implants than those without implants.
• Second Generation Effects: There have been concerns raised regarding potential damaging effects on children born of mothers with implants. A review of the published literature on this issue suggests that the information is insufficient to draw definitive conclusions.