Risks and complications with breast implants

Complications are unfavourable evolutions or consequences of a disease, a health condition, a therapy or a procedure. The goal of surgery is to have as few complications as possible and the surgeon will try to minimize them, however, breast reconstruction is associated with risks and complications. We have compiled a list of the most common complications, with an explanation and, where appropriate, with recommendations.

  • Capsular contracture or capsular fibrosis: When any foreign body is placed inside an organism, the physiological reactions include metabolisation, expulsion or isolation. In the latter case, a capsule is formed around the foreign body, which is what happens with breast implants in the human body. This capsule can tighten around the implant and contract. The contraction deforms the implant shape and thus the shape of the breast. Additionally, the capsule can become very hard and cause pain. This complication is referred to as "capsular contracture" and its occurrence rates vary according to implant surface. A significant capsular contracture will result in implant removal (see also “Breast Implant Types”)
  • Seromas: Seromas develop as an accumulation of serous fluid around the implant, which can lead to pain and excessive swelling of the breast(s). Several reasons can cause seromas: intraoperative or postoperative traumatization, excessive postoperative mobility of the implant or infection. Possible treatments: compression, drainage or implant removal, if necessary. Seromas may develop early, immediately after surgery, or late, occurring several months after surgery. See the section on Anaplastic Large-Cell Lymphoma.
  • Pain: Pain may occur in the operated area as well as in the chest muscle, shoulder or arm after breast surgery. Continuous pain may be due to improperly sized or placed implants. Over-sized implants, capsular contracture as well as irritations due to excessive implant movement, may provoke pain. Please consult your surgeon immediately to clarify the cause of pain following an operation.
  • Reddening of the skin or “rash”: This complication can be observed a low percentage of patients. This reddening of the skin should not be confused with an infection. It differs from an infection by itching and the absence of systemic infection symptoms. It usually occurs 7 to 10 days after the implantation and can last 2 to 3 weeks. The use of steroids may be necessary.
  • Chest wall deformity: The rib cage may be deformed due to the pressure exerted by the implant.
  • Calcification: Benign calcification around the implant is possible.  
  • Infections: Infections may present with fever and/or inflammation. Infections in connection with breast implants are very rare: 0.114%.1 Infections with unclear aetiology that occur after breast implantation surgery should be treated immediately. The use of antibiotics, drainage or implant removal may be necessary. Not all infections can be treated while the implant remains in the body. The “toxic shock” syndrome has been reported in extremely rare cases in connection with breast implants.
  • Inflammation or irritation: Reactions of the body to an infection or injury showing as redness, swelling, pain.
  • Implant rupture: Failure of the integrity of the implant shell. Implant damage (intraoperatively, e.g. by too short incisions, by surgical instruments, or postoperatively, e.g. in case of punctures, biopsies etc.), trauma or material fatigue are, in our opinion, the most frequent reasons. After rupture of a gel-filled implant, the consistency of the silicone gel prevents diffusion. However, it is not guaranteed that the gel remains a complete entity. Ruptures may be noticeable (symptomatic ruptures) or not (silent ruptures). Magnetic resonance imaging (MRI) is the most effective method for detecting silent rupture of silicone gel-filled breast implants. If a rupture is diagnosed the implant should be replaced.
  • Permeation of silicone: All modern breast implants are equipped with special barrier layers to prevent the diffusion of silicone particles through the shell. While the passage of low molecular weight silicone components through the shell of the implant cannot be completely excluded, the small amounts of gel remain within the tissue capsule that physiologically grows around the implant.2
  • Granuloma: Granulomas are localized nodular inflammations, which may result from an implant rupture or from silicone permeation. Granulomas of an unknown origin may require a biopsy or implant removal.
  • Swelling of the axillary lymph nodes: Lymph nodes are small structures located all over the body around blood vessels. They are part of the lymphatic system of the body. They can swell and become tender or painful in cases of a local infection, an infection affecting the whole body, cancer or immune disorders. Axillary lymph nodes are the lymph nodes located in the armpit and which drain the breast area of fluid. Some patients with breast implants have been found to have enlarged lymph nodes in the armpit. This is referred to as lymphadenopathy. It has been reported to occur in women with both ruptured and intact silicone gel breast implants. If an enlarged lymph node becomes painful, it may need to be surgically removed. You should immediately report any painful or enlarged lymph nodes to your doctor.

Breast cancer

The extensive studies available show that women with breast implants are not subject to a higher risk of breast cancer than women without breast implants.3 In other words, a breast implant has no influence on the occurrence of breast cancer. While scientists do discuss the theoretical risks of this disease with implants, breast cancer as a direct result of breast implants has not been observed in humans.

It is important that you undergo all the usual breast examinations, such as self-examination and possible imaging procedures (mammary sonography, tomosynthesis, mammogram, magnetic resonance imaging (MRI)) to detect possible breast cancer. Modern imaging techniques such as sonography, MRI or computer tomography (CT) help to find tumours at an early stage.4

Make sure to self-examine your breasts at regular intervals. For post-operative self-examination, your surgeon should instruct you on how to distinguish between the implant and your own tissue to enable you to detect nodules yourself. Do not just touch your breasts; also look for swelling, redness and inflammation, as well as any breast deformities, even if these are not painful. If you find any changes, please consult a surgeon.

BIA-ALCL

Reports from regulatory agencies and medical literature have shown an association between breast implants and the development of ALCL, resulting in the term BIA-ALCL or Breast Implant-Associated Anaplastic Large Cell Lymphoma. This means that women with breast implants may have a small increased risk in developing ALCL. There are several different estimates of the risk of developing BIA-ALCL.

The vast majority of cases in literature concern patients with history of use of textured implants.

ALCL is currently classified as a form of non-Hodgkin's lymphoma (NHL) - a cancer of the immune system. It typically presents as a late seroma – the accumulation of liquid within the capsule –but it may also occur with the formation of a mass. The symptoms may occur well after the surgical incision has healed, often years after implant placement, but there are known cases with a shorter time of occurrence.

ALCL is a rare but serious type of cancer. There are documented cases of death due to the spreading of the disease out of the capsule. When detected early and timely treated, this disease has a positive prognosis.

In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue, but for some patients chemotherapy and radiation therapy may be necessary.

It is very important that you continue to attend regular check-ups and perform self-examination. If symptoms such as swelling, pain or a lump in the implant region occur, you should immediately inform your doctor.

If you have breast implants and have no symptoms, you do not need to do anything, but you should continue to routinely monitor your breast implants and follow your routine medical care. Removing the implants is not recommended in women with no symptoms without a confirmed diagnosis of BIA-ALCL.

Sources:

1  Brand, K.G. (1993) Infection of mammary prostheses: a survey and the question of prevention Ann. Plast. Surg. 30: 289 et seq.

2 . Evans, G.R.D., Baldwin, B.J. (1997) From cadavers to implants: silicon tissue assays of medical devices. Plast. Reconstr. Surg. 100, 1459-1465; Evans, G.R.D., Netscher, D.T., Schusterman, M.A., Kroll, S.S., Robb, G.L., Reece, G.P., Miller, M.J. (1996) Silicon tissue assays: a comparison of non-augmented cadaveric and augmented patient levels. Plast. Reconstr. Surg. 97, 1207-1214; McConnell, J.P., Moyer, T.P., Nixon, D.E., Schnur, P.L., Salomao, D.R., Crotty, T.B., Weinzweig, J., Harris, J.B., Petty, P.M. (1997) Determination of silicon in breast and capsular tissue from patients with breast implants performed by inductively coupled plasma emission spectroscopy. Comparison with tissue histology. American Journal of Clinical Pathology 107, 236-246.

3 . NIH-National Cancer Institute, https://www.cancer.gov/types/breast/risk-factsheet, retrieved on 05.10.2018; American Council On Science And Health (1996) Silicone breast implants: why has science been ignored? The report of the independent review group (1998) Silicone breast implants. Crown, London; Friis, S., McLaughlin, J.K., Mellemkjaer, L., Kjoller, K.H., Blot, .J., Boice, J.D. Jr., Fraumeni, J.F. jr., Olsen, J.H. (1997) Breast implants and cancer risk in Denmark. International Journal of Cancer 71, 956-958; Deapen, D.M., Bernstein, L., Brody, G.S., (1997) Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles study. Plast. Reconstr. Surg. 99, 1346-1353; Bryant, H., Brasher, P. (1998) Breast implants and breast cancer – reanalysis of a linkage study. N. Eng. J. Med. 332, 1535-1539.

4.  Ganott, M.A., Harris, K.M., Ilkhanipour, Z.S., Costa-Greco, M.A. (1992) Augmentation mammoplasty: normal and abnormal findings with mammography and US. RadioGraphics 12, 281-295; Barloon, T.J., Young, D.C., Bergus, G. (1996) The role of diagnostic imaging in women with breast implants. American Family Physician 54, 2029-2036; Eklund, G.W., Busby, R.C., Miller, S.H., Job, T.S. (1988) Improved imaging at the augmented breast. American Journal of Roentgenology 151, 469-473. Greenstein, O.S. (2000) MR imaging of the breast. Radiologic Clinics of North America 38(4), 899ff; Belli, P., Romani, M., Magistelli, A., Mossetti, R., Pastore, G., Constantini, M. (2002) Diagnostic imaging of breast implants: role of MRI. RAYS 27(4), 259-277.