Every surgical procedure involves a certain amount of risk and it is important that you understand the risks involved with augmentation mammaplasty. Additional information concerning breast implants may be obtained from the implant manufacturer.
An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of women do not experience the following complications, you should discuss each of them with your surgeon to make sure you understand the risks, potential complications, and consequences of breast augmentation. Problems associated with breast implants can be inherent to this type of implanted medical device or relate to complications of a surgical procedure. Additional advisory information regarding this subject should be reviewed by patients considering surgery that involves breast implants.
While every patient experiences her own individual risks and benefits following breast implant surgery, clinical data suggests that most women will be satisfied with the outcome of breast implant surgery despite the occurrence of problems inherent with breast implant surgery.
Inherent Risks of Breast Implants
Implants- Breast implants, similar to other medical devices, can fail. When a silicone gel-filled implant ruptures, the gel material is usually contained within the scar tissue surrounding the implant (intracapsular rupture). In some cases, the gel may escape beyond the capsule layer and go into the breast tissue itself (extracapsular rupture and gel migration) or to more distant locations. Migrated silicone gel may be difficult or impossible to remove. Rupture of a breast implant may or may not produce local firmness in the breast.
Patients are advised to refer to individual manufacturer’s informational materials regarding the incidence of device rupture reported during pre-market studies. It is impossible to predict the biologic response that a patient’s tissues will exhibit to the placement of breast implants or how you will heal following surgery.
Rupture can occur as a result of an injury, from no apparent cause or during mammography. Rupture of a silicone breast implant is most often undetected (silent rupture). It is possible to damage an implant at the time of surgery. Damaged or broken implants cannot be repaired. Ruptured or damaged implants require replacement or removal. Breast implants can wear out, they are not guaranteed to last a lifetime and future surgery may be required to replace one or both implants.
An Ultrasound or MRI (magnetic resonance imaging) scan is advised to evaluate the possibility of implant rupture, yet it may not be 100% accurate in diagnosing implant integrity. Patients are advised to have some kind of scan, starting at 3 years after surgery and then every 3-4 years thereafter.
Capsular contracture- Scar tissue, which forms internally around the breast implant, can tighten, and make the breast round, firm, and possibly painful. Excessive firmness of the breasts can occur soon after surgery or years later. The occurrence of symptomatic capsular contracture is not predictable. The incidence of symptomatic capsular contracture can be expected to increase over time. Capsular contracture may occur on one side, both sides or not at all. Treatment for capsular contracture may require surgery, implant replacement, or implant removal. Capsular contracture may reoccur after surgical procedures to treat this condition and risk of recurrence increases to 50%.
Implant extrusion / Tissue necrosis- Lack of adequate tissue coverage or infection may result in exposure and extrusion of the implant through the skin. Tissue breakdown (necrosis) has been reported with the use of steroid drugs, after chemotherapy/radiation to breast tissue, due to smoking, microwave diathermy, and excessive heat or cold therapy. In some cases, incision sites fail to heal normally. An implant may become visible at the surface of the breast as a result of the device pushing through layers of skin. If tissue breakdown occurs and the implant becomes exposed, implant removal may be necessary. Permanent scar deformity may occur.
Skin wrinkling and rippling- Visible and palpable wrinkling of implants can occur. Some wrinkling is normal and expected. This may be more pronounced in patients who have saline-filled implants with textured surfaces or thin breast tissue. Some patients may find wrinkles cosmetically undesirable. Palpable valve, wrinkling and/or folds may be confused with palpable tumours and questionable cases must be investigated. An implant may become visible at the surface of the breast as a result of the device pushing through layers of skin.
Bottoming Down- When the implants fall below the central mound of the breast creating more fullness below the nipple rather than behind it. Further treatment may be necessary to correct this complication.
Double Bubble- When the breast tissue falls below the central mound of the breast creating the appearance of two breasts. Further treatment may be necessary to correct this complication.
High Riding Implant- Sometimes following submuscular or dual plane placements, one or both implants may attach to the underlying tissue and remain high. Further treatment may be necessary to correct this complication.
Change in nipple and skin sensation- Some change in nipple sensation is not unusual right after surgery. After several months, most patients have normal sensation. Partial or permanent loss of nipple and skin sensation may occur occasionally. Changes in sensation may affect sexual response or the ability to breast feed a baby.
Calcification- Calcium deposits can form in the scar tissue surrounding the implant and may cause pain, firmness, and be visible on mammography. These deposits must be identified as different from calcium deposits that are a sign of breast cancer. Should this occur, additional surgery may be necessary to remove and examine calcifications.
Chest wall deformity- Chest wall deformity has been reported secondary to the use of tissue expanders and breast implants. The consequences of chest wall deformity is of unknown significance.
Implant displacement- Displacement, rotation, or migration of a breast implant may occur from its initial placement and can be accompanied by discomfort and/or distortion in breast shape. Unusual techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to correct this problem.
Surface contamination of implants- Skin oil, lint from surgical drapes, or talc may become deposited on the surface of the implant at the time of insertion. The consequences of this is unknown.
Breast feeding- Breast milk is the best food for babies. Many women with breast implants have successfully breast fed their babies. It is not known if there are increased risks in nursing for a woman with breast implants. A study measuring elemental silicon (a component of silicone) in human breast milk did not indicate higher levels from women with silicone-filled gel implants when compared to women without implants. Cow’s milk contains higher levels of elemental silicon as compared to human milk. Implant placement techniques that involve incisions through the nipple and areolar locations may reduce the ability to successfully breast feed. If a woman has undergone a mastectomy, it is unlikely that she would be able to breast feed a baby on the side where the breast was removed.
Unusual activities and occupations- Activities and occupations which have the potential for trauma to the breast could potentially break or damage breast implants, or cause bleeding/seroma.
Breast Implant Associated aplastic Large Cell Lymphoma (BIA-ALCL)
What is BIA-ALCL?
BIA-ALCL is a rare and treatable type of non-Hodgkin’s lymphoma, a cancer of the cells of the immune system, that can develop around breast implants.
Is BIA-ALCL as breast cancer
No. Even though BIA-ALCL is found in the breasts of some women with breast implants, it is not breast cancer. BIA-ALCL develops in the fluid around breast implant and is usually contained by the fibrous capsule around implants it does not develop in the breast tissue.
What are the symptoms of BIA-ALCL?
The most common symptom is a persistent swelling of the breast 2 to 28 years after the insertion of breast implants, which may present as fluid collecting around the implant. It can also present as a lump in the breast or armpit.
What is the risk of developing BIA-ALCL?
As BIA-ALCL is a rare condition, it is difficult to be certain about the absolute risk of developing this condition.
However, the following report have been issued:
- BIA-ALCL affects approximately 1 in 50,000 to 300,000 patients with breast implants (January 2016)
- The lifetime risk for BIA-ALCL in previous epidemiological studies ranges from 1:30,000 to 1:50,000.
- The figure derived and issued by the Australian government was in the range of 1:1,000 to 1:10,000 for Australian/New Zealand patients with textured/polyurethane implants.
As comparison, the risk of breast cancer is about one in eight women.
How is BIA-ALCL diagnosed?
If a woman develops swelling of the breast which has an implant they are sent for an ultrasound scan and if fluid is detected this will be removed and tested for BIA-ALCL. Specific tests are asked for to exclude or diagnose BIA-ALCL. Most fluid collections around breast implants are not BIA-ALCL but proper testing will be able to tell them apart. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases MRI and PET/CT scans may be performed to help stage the condition.
How is BIA-ALCL treated and what is the prognosis?
The majority of cases are cured with the removal of implants and the fibrous capsule around them from both breasts. The majority of patients require no additional treatment.
Are some patients at greater risk than others?
It is not possible to predict who will develop BIA-ALCL, and while the Australian Government reports a higher risk of BIA-ALCL in those patients with textured/polyurethane implants, the data is not yet well established. This risk remains far less than that other known risks, such as capsular contracture. BIA-ALCL has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.
Should patients with breast implants be screened for BIA-ALCL?
Expert opinion is that asymptomatic women without breast changes do not require more than routine follow-up. If a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo examination and appropriate imaging, including ultrasound and fine needle aspiration of any peri-implant fluid.
Should patients have their implants removed?
Neither the FDA nor the Australian Government’s report suggest additional screening or removal of implants for asymptomatic women. Breast implants are not lifelong devices and in general all will need to be removed or replaced at some point. The commonest reasons for implant removal or replacement are capsular contracture, implant migration, implant leakage and rupture. Without symptoms or signs of BIA-ALCL routine implant removal is not required unless there are other concerns
What causes BIA-ALCL?
FDA, other international organisations and the implant manufacturers are working proactively to study BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study.
Bacteria have been identified within the lymphoma and around implants in affected breasts, and there is accumulating evidence that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause BIA-ALCL. Research is ongoing to investigate this condition and better understanding of it.
Genetic factors may play a role. The Australia/New Zealand risk appears higher than other studies have indicated. Some geographic areas have reported very few cases. Ongoing data collection worldwide will help to determine whether or not there are any genetic propensities for this disease.
Do national and international plastic surgery organisations recommend against the use of textured implants?
At this point, the data suggest that BIA-ALCL occurs more frequently following textured than smooth breast implants however available data does not support discontinuance of textured implants and it is not possible to exclude the occurrence of BIA-ALCL in association with smooth implants either at this time.
The best practice is always for the physician to discuss with each patient the known risks and potential complications associated with any procedure. It is important for the patient and her doctor to frankly discuss all options available, and the risks involved.
Patients are offered options regarding breast implants in terms of sizing, shape, and surface. Textured implants may offer advantages in terms of lower risk of capsular contracture and lower risk of malrotation when an anatomically shaped implant is utilised. Depending on a particular patient’s needs, a textured implant may be preferable. The plastic surgeon must provide a frank and transparent discussion regarding the benefits and risks of implants, both smooth and textured.
The patient must then make an informed decision, based upon her own assessment of her needs and the risks involved. It is critical that the patient makes a fully informed decision following a full discussion of the risks and benefits.
Can new breast implants be inserted when BIA-ALCL is treated?
Current treatment protocols indicate that the removal of both breast implants with the capsule around them (total capsulectomy) is required because a small number of cases that have been diagnosed on both sides at the same time. Implants are not replaced at the same operation. Smooth implants have been re-inserted 12 months following the adequate treatment of BIA-ALCL without disease progression however the safety of this strategy is still being investigated
Where can I get more information?
More information can be found at:
ISAPS: www.isaps.org
ASPS: www.plasticsurgery.org/alcl
ASAPS: www.surgery.org/professionals
PSF: www.thepsf.org/research/clinical-impact/profile.htm
FDA: https://www.fda.gov
What should I do if I am considering breast implants?
Women who are considering breast implant surgery should discuss the risks and benefits of the procedure with their Plastic Surgeon including the risks of BIA-ALCL. There are different implant types available and implant selection needs to take into account the risks and benefits of specific choices. Implant selection will be different from one person to the next. Breast implants are not lifetime devices and women with breast implants should all consider that they will require revision or replacement of the breast implants at some point.
Inherent Surgical Risk of Breast Implant Surgery
Bleeding- It is possible, though unusual, to experience a bleeding episode during or after surgery. Should post-operative bleeding occur, it may require emergency treatment to drain accumulated blood (hematoma). Do not take any aspirin or anti-inflammatory medications for ten days before surgery, as this may increase the risk of bleeding. Non-prescription “herbs” and dietary supplements can increase the risk of surgical bleeding. Hematoma can occur at any time following injury to the breast.
Seroma- Fluid may accumulate around the implant following surgery, trauma or vigorous exercise. Additional treatment may be necessary to drain fluid accumulation around breast implants. This may contribute to infection, capsular contracture, or other problems.
Infection- Infection is unusual after this type of surgery. It may appear in the immediate post-operative period or at any time following the insertion of a breast implant. Subacute or chronic infections may be difficult to diagnose. Should an infection occur, treatment including antibiotics, possible removal of the implant, or additional surgery may be necessary. Infections with the presence of a breast implant are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the breast implant may have to be removed. After the infection is treated, a new breast implant can usually be reinserted. It is extremely rare that an infection would occur around an implant from a bacterial infection elsewhere in the body, however, prophylactic antibiotics may be considered for subsequent dental or other surgical procedures. In extremely rare instances, life-threatening infections, including toxic shock syndrome have been noted after breast implant surgery.
Skin scarring- Excessive scarring (keloid/hypertrophic) is uncommon. In rare cases, abnormal scars may result. Scars may be unattractive and of different colour from surrounding skin. Additional surgery may be needed to treat abnormal scarring after surgery.
Allergic reactions- In rare cases, local allergies to tape, suture material, or topical preparations have been reported. Systemic reactions which are more serious may result from drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.
Surgical anaesthesia- Both local and general anaesthesia involve risk. There is the possibility of complications, injury, and even death from all forms of surgical anaesthesia or sedation.
Delayed healing- Wound disruption or delayed wound healing is possible. Smokers have a greater risk of skin loss and wound healing complications.
Thrombosed veins- Thrombosed veins, which resemble cords, occasionally develop in the area of the breast and resolve without medical or surgical treatment.
Pain- Pain of varying intensity and duration may occur and persist after breast implant surgery. Pain may be the result of improper implant size, placement, surgical technique, capsular contracture, or sensory nerve entrapment or injury.
Additional Breast Implant Advisory Information
Breast cancer- Current medical information does not demonstrate an increased risk of breast cancer in women who have breast implant surgery for either cosmetic or reconstructive purposes. It is recommended that all women perform periodic self-examination of their breasts, have mammography according to American Cancer Society guidelines, and seek professional care should they notice a breast lump. Care must be exercised during breast biopsy procedures to avoid damaging the breast implant.
Mammography- It is important to Inform your mammography technologist of the presence of breast implants so that appropriate mammogram studies may be obtained. Patients with capsular contracture may find mammogram techniques painful and the difficulty of breast imaging will increase with the extent of contracture. Ultrasound, and MRI may be of better options to evaluate breast lumps and the condition of the implant(s). Although not a necessity, patients may wish to undergo a preoperative breast ultrasound to establish a baseline view of their breast tissue. You may be advised to undergo a MRI scan in the future to verify the condition of your breast implants.
Long term results- Subsequent alterations in breast shape may occur as the result of ageing, weight loss or gain, pregnancy, or other circumstances not related to augmentation mammaplasty. Breast sagginess may normally occur.
Unsatisfactory result- You may be disappointed with the results of surgery. Asymmetry in implant placement, displacement, nipple location, unanticipated breast shape and size may occur after surgery. Breast size may be incorrect. Unsatisfactory surgical scar location may occur. It may be necessary to perform additional surgery to improve your results or remove implants.
Removal / replacement of breast implants- Future revision, removal, or replacement of breast implants and the surrounding scar tissue envelope involves surgical procedures with risks and potential complications. There may be an unacceptable appearance of the breasts following removal of the implant.
Immune system diseases and unknown risks- A small number of women with breast implants have reported symptoms similar to those of known diseases of the immune system, such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma, and other arthritis-like conditions. To date, after several large epidemiological studies of women with and without implants, there is no scientific evidence that women with either silicone gel-filled or saline-filled breast implants have an increased risk of these diseases. These diseases appear no more common in women with implants than those women without implants. The effects of breast implants in individuals with pre-existing immune system and connective-tissue disorders is unknown. There is the possibility of unknown risks associated with silicone breast implants and tissue expanders.
Capsule Squeeze Procedures-Closed capsulotomy,the process of forcefully squeezing the fibrous capsule around a breast implant to breakup scarring is not recommended. This may result in rupture of the breast implant, bleeding,or other complications.
Additional Surgery Necessary
Should complications occur, additional surgery or other treatments may be necessary. Even though risks and complications occur infrequently, the risks cited are particularly associated with breast augmentation; other complications and risks can occur but are even more uncommon. The practice of medicine and surgery is not an exact science. Although good results are expected, there is no guarantee or warranty expressed or implied on the results that may be obtained.
Additional Advisories
Deep Venous Thrombosis, Cardiac and Pulmonary Complications:Surgery, especially longer procedures, may be associated with the formation of, or increase in, blood clots in the venous system. Pulmonary complications may occur secondarily to blood clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anaesthesia. Pulmonary and fat emboli can be life threatening or fatal in some circumstances. Air travel, inactivity and other conditions may increase the incidents of blood clots travelling to the lung causing a major blood clot that may result in death. It is important to discuss with your surgeon any past history of blood clots of swollen legs that may contribute to this condition. Cardiac complications are a risk with any surgery and anaesthesia, even in patients without symptoms. If you experience shortness of breath, chest pain or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you might require hospitalisation and additional treatments.
Smoking, second-Hand Smoke Exposure, Nicotine Products (Patch, Gum, Nasal spray): Patients who are currently smoking, use tobacco products, or nicotine products are at a greater risk for significant surgical complications of skin dying, delay the healing and additional scarring. Individuals exposed to second hand smoke are also at potential risk for similar complications attributable to nicotine exposure. Additionally, smokers may have a significant negative effect from anaesthesia and recovery from anaesthesia, with coughing and possibly increased bleeding. Individuals who are not exposed to tobacco smoke or nicotine containing products have a significantly lower risk of this type of complication.
It is important to refrain from smoking at least six weeks before surgery and until your surgeon states it is safe to return, if desired.
Female patients information: It is important to inform your surgeon if you use birth control pills, oestrogen replacement, or if you believe you may be pregnant. Many medications including antibiotics may neutralize the preventive effects of birth control pills, allowing for conception and pregnancy.
Intimate Relations after Surgery: Surgery involves coagulating of blood vessels and increased activity of any kind may open these vessels leading to a bleed or hematoma. Increased activity that increases your pulse or heart rate may cause additional bruising, swelling and the need for return to surgery and control of bleeding. It is wise to refrain from sexual activity until your surgeon states it is safe.
Sun Exposure – Direct or Tanning Salon- The effects of the sun are damaging to the skin. Exposing the treated areas to sun may result in increased scarring, color changes, and poor healing. Patients who tan, either outdoors or in a salon, should inform their surgeon and either delay treatment, or avoid tanning until the surgeon says it is safe to resume. The damaging effect of sun exposure occurs even with the use sun block or clothing coverage.
Medications: There are many adverse reactions that occur as the result of taking over the counter, herbal, and/or prescription medications. Be sure to check with your surgeon about any drug interactions that may exist with medication that you are already taking. If you have an adverse reaction, stop the medication immediately and call your surgeon for further instructions. If the reaction is severe, go immediately to the nearest hospital. When taking the prescribed pain medication after surgery, realize that they can affect your thought process. Do not drive, do not operate complex equipment, do not make any important decisions and do not drink any alcohol while taking these medications. Be sure to take your prescribed medication only as directed.
