Adverse Events

Because breast implant surgery is more often performed using general anesthesia, it is associated with the same risks as other invasive surgical procedures.

After breast implant surgery, patients might experience swelling, hardness, discomfort, itching, bruising, twinges and pain over the first few weeks. Potential adverse events that may occur with silicone gel-filled breast implant surgery include:

 

Side Effect Description Correction
Capsular Contracture Normally, capsules of collagen fibers form as an immune response around a foreign body, such as a breast implant, tending to isolate it. Capsular contracture occurs when the capsule tightens and squeezes the implant. This can cause the implant to turn rigid (from slightly firm to quite hard) and the firmest ones can cause varying degrees of discomfort, pain and palpability. In addition to the firmness, capsular contracture can result in a deformed breast, visible surface wrinkling and/or displacement of the implant. Detection of breast cancer by mammography may also be more difficult. Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time. Capsular contracture occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery. Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.  

Surgical removal or release of the capsule, or removal and possible replacement of the implant itself.

Rupture Breast implants rupture when the shell develops a tear or hole. Rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is in place. The following may cause implants to rupture: damage by surgical instruments, implant stress and weakening during implantation, age and design of the implant, submuscular rather than subglandular location, occurrence of post-operatory hematomas or seromas, folding or wrinkling of the implant shell, excessive force to the chest (e.g., during closed capsulotomy, which is contraindicated), trauma, compression during mammographic imaging, and severe capsular contracture. Silicone gel-filled implant ruptures are most often silent. (MRI examination is currently the best screen method for silent rupture.) This means that most of the time neither doctor nor patient will know if the implant has a tear or hole in the shell. This is why a first MRI is recommended after 3 years, and then at regular intervals every 2 years thereafter, to screen for ruptures. Sometimes there are symptoms associated with gel implant rupture, such as lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast. When MRI findings of rupture are found, or if there are signs or symptoms of rupture, the implant should be removed, with or without replacing it.
Pain Most women undergoing augmentation or reconstruction with a mammary implant will experience some post-operatory breast and/or chest pain. While this pain normally recedes in most women as they heal after surgery, it can become a chronic problem in other women. Hematoma, migration, infection, implants that are too large, or capsular contracture can cause chronic pain. Sudden, severe pain may be associated with implant rupture. The surgeon should instruct the patient to immediately report if there is significant pain or if pain persists. Surgeon will pursue the best clinical solution to address the health situation.
Changes in Nipple and Breast Sensation Breast surgery can result in an increased/decreased breast and/or nipple sensitivity. Typically the sensation is lost after complete mastectomy where the nipple itself is removed, and can be severely lessened by partial mastectomy. The range of changes varies from intense sensitivity to no feeling in the nipple or breast following surgery. While some of these changes can be temporary, they can also be permanent, and may affect the patient’s sexual response or ability to nurse. The surgeon should instruct the patient to report if the symptom persists.
Infection Infection can occur with any surgery or implant. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. In addition, breast and nipple piercing procedures may increase the possibility of infection. Infections in tissue with an implant present are harder to treat than infections in tissue without an implant.

As with other surgical procedures, toxic shock syndrome in rare instances has been noted in women after breast implant surgery. This is a life- threatening condition and its symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, and/or sunburn-like rash.

Patients should be instructed to contact their doctor immediately for diagnosis and treatment if they have these symptoms.

Antibiotics will reduce the infection process. 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.

Hematoma/ Seroma Hematoma is a collection of blood within the space around the implant, and a seroma is a build-up of fluid around the implant. Having a hematoma and/ or seroma following surgery may result in infection and/or capsular contracture later on. Symptoms from a hematoma or seroma may include swelling, pain, and bruising. If a hematoma or seroma occurs, it will usually be soon after surgery. However, they can also occur at any time after injury to the breast. Body absorbs small hematomas and seromas, some will require surgery, typically involving draining, and potentially placing a surgical drain in the wound temporarily for proper healing. A small scar can result from surgical draining. Implant rupture also can occur from surgical draining if there is damage to the implant during the procedure.
Breast-feeding Although most women with breast implants who attempt nursing have success- fully breast-fed their babies, it is not known if there are increased risks for a woman with breast implants or if the children of women with breast implants are more likely to have health problems. At this time, it is not known if it is possible for a small amount of silicone to pass from the breast implant silicone shell into breast milk during breast-feeding, or what the potential consequences might be. A periareolar surgical approach may further increase the chance of breast-feeding difficulties. However, the American Academy of Pediatrics has stated that there is no reason why a woman with implants should refrain from nursing.
Calcification Calcium deposits can form in scar tissue surrounding the implant and may cause pain and firmness, and be visible on a mammography. These deposits must be identified as different from calcium deposits that are a sign of breast cancer. Calcium deposits also occur in women who undergo breast reduction procedures, in patients who have had hematoma formation, and even in the breasts of women who have not undergone any breast surgery. The occurrence of calcium deposits significantly increases with age. Additional surgery may be necessary to remove and examine calcifications.
Delayed Wound Healing Some patients may experience a prolonged wound healing time. Smoking may interfere with the healing process. Delayed wound healing may increase the risk of infection, extrusion, and necrosis. Wound healing times may vary depending on the type of surgery or incision. The surgeon should instruct the patient to report if there is a delayed on the wound healing. Also to stop smoking before and after the surgical procedure.
Implant Extrusion Lack of adequate tissue coverage, local trauma or infection may result in exposure and extrusion of the implant. This has been reported with the use of steroid drugs or after radiation therapy of breast tissue. If tissue breakdown occurs and the implant becomes exposed, implant removal may be necessary, which may result in additional scarring and/or loss of breast tissue.
Necrosis Necrosis is the formation of dead tissue around the implant. This may prevent wound healing. Permanent scar deformity may occur following necrosis. Factors associated with necrosis include infection, use of steroids in the surgical pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy. Surgical correction and/or implant removal.
Granulomas These are benign lumps that can form when body cells surround foreign material such as silicone. It should be further evaluated to rule out a malignancy.
Breast Tissue Atrophy/Chest Wall Deformity The pressure of the breast implant may cause the breast tissue to thin and shrink (with increased implant visibility and palpability), potentially leading to chest wall deformity. This can occur while implants are still in place or following implant removal without replacement Additional surgeries and/or unacceptable dimpling/creasing of the breast.
Lymphadenopathy Literature reports associate lymphadenopathy with both intact and ruptured silicone breast implants. One study reported that armpit lymph nodes from women with both intact and ruptured silicone gel implants had abnormal tissue reactions, granulomas, and the presence of silicone. These reports occurred in cases of women who had implants from a variety of manufacturers and implant models. Silicone lymphadenopathy is a foreign body reaction that does not warrant treatment unless it is symptomatic or interferes with breast cancer detection.
Unsatisfactory Results Unsatisfactory results such as wrinkling, asymmetry, implant displacement/ migration, incorrect size, implant palpability/visibility, scar deformity, and/or hypertrophic scarring, may occur. Some of these results may cause discomfort. Pre-existing asymmetry may not be entirely correctable by implant surgery. Revision surgery could be indicated to increase patient satisfaction, but this involves additional considerations and risks. Careful preoperative planning and surgical technique can minimize but not always prevent unsatisfactory results.
Other Reported Conditions There have been reports in the literature of other conditions in women with silicone breast implants. Many of these conditions have been studied to evaluate their potential association with breast implants. However, no causal relationship has been established between breast implants and the conditions listed below.
Condition Description
Connective Tissue Disease (CTD) Since the early 1990s, nearly a dozen comprehensive systemic reviews have been commissioned by government health ministries in several countries to examine the alleged links between silicone gel breast implants and systemic diseases. A clear consensus has emerged from these independent scientific reviews that there is no clear evidence of a causal link between the implantation of silicone breast implants and connective tissue disease.
Cancer Breast cancer reports in the medical literature reveal that patients with breast implants are not at a greater risk than those without breast implants for developing breast cancer. Some reports have suggested that breast implants may interfere with or delay breast cancer detection by mammography and/ or biopsy; however, other reports in the medical literature indicate that breast implants do not significantly delay breast cancer detection or adversely affect cancer survival prognosis in implanted women. Some studies even suggest lower rates of breast cancer in women with breast implants.
Neurological Disease, Signs, and Symptoms Some women with breast implants have experienced neurological disturbances (e.g., visual symptoms or alterations in sensation, muscle strength, walking, balance, thinking or memory) or diseases (e.g., multiple sclerosis) and they believe those symptoms are related to their implants. However, there is no evidence in published literature of a causal relationship between breast implants and neurological disease.
Gel Diffusion Small quantities of silicone may diffuse through the elastomer envelope of silicone gel-filled implants. The detection of small quantities of silicone in the periprosthetic capsule, axillary lymph nodes and other distal regions in patients with apparently intact gel-filled implants has been reported in the literature. Some studies on long-term implants have suggested that gel-bleed may contribute to the development of capsular contracture and lymphadenopathy. On the other hand, evidence against gel-bleed being a significant contributing factor to capsular contracture and other local complications is provided by the fact that there are similar or lower complication rates for silicone gel-filled breast implants than for saline-filled breast implants.
Gel Fracture Gel fracture may occur with cohesive silicone as a result of handling during surgery or alternatively due to the development of capsular contracture and may result in device distortion. This can lead to both patient and surgeon dissatisfaction with the aesthetic outcome of surgery and may require a second procedure.
Interference with Mammography Breast implants (especially in subglandular placement) may complicate the interpretation of mammographic images by obscuring the underlying breast tissue and/or by compressing overlying tissue. Despite of the fact that the pre-sence of breast implants lessens tissue compression range during mammography, 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 implanted and non-implanted patients. Accredited mammography centers, technicians with experience in imaging patients with breast implants, and use of displacement techniques are needed to adequately visualize breast tissue in the implanted breast. The current recommendations for preoperative/screening mammograms are no different for women with breast implants than for those women without implants.