Possible complications

Breast augmentation with implants has been performed since the 1960’s and continued to be the world’s most popular cosmetic procedure worldwide (1).

However, as with any surgical procedure, possible complications may occur in association with breast augmentation or breast reconstruction procedures, as a result of individual health conditions, medication, surgical technique, and postoperative care.

At POLYTECH we believe in providing comprehensive safety-related information to patients, so that their decision will remain not only personal – but well informed.

The extent to which we may provide information directly to patients varies according to what is allowed by the local national legislation. Always make sure to ask your surgeon for comprehensive and clear information about the surgery and the products.

Careful planning and open discussion with your surgeon about the expected results can minimize the chances of unsatisfactory result. When considering a reoperation due to an unsatisfactory result, please note that the chances for complications increase with revision operation.

After breast implants surgery, it is important that you follow your surgeon’s recommendations, and that you undergo regular check-ups. If you are experiencing problems, aesthetic impairment or pain following breast implant surgery, you should immediately inform your surgeon, and consider the available solutions.

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Possible complications include:

  • Capsular contracture or capsular fibrosis: Due to a natural reaction of the host organism, a capsule is formed around all foreign bodies inserted into the tissue, implants included. This capsule can draw tight 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 is related to the implant surface:textured and PU-covered surfaces have lower risks of capsular contracture.
  • Seromas: Seromas develops as an accumulation of serous fluid around the implant, which can lead to excessive swelling of the breast(s). Several reasons can cause Seromas: intraoperative or post operative traumatization, excessive postoperative mobility of the implant or the formation of a biofilm on the implant surface. Possible therapies: immobilization, compression, drainage or explantation, if necessary.
  • Pain: 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. Pain may occur in the operated area as well as in the pectoralis and shoulder-arm areas after mammary surgery.
  • Reddening of the skin or “rash”: it can be observed in different frequencies with specific indications, depending on the surface structure (approx. 1–5% for Microthane®-surfaced mammary implants). 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.  

Complications related directly to the surgery:

  • Infections: Infections in connection with breast implants are very rare: 0.114% (4).
  • Infections with unclear etiology that occur after breast implantation surgery should be treated immediately. The use of antibiotics, drainage or explantation 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.
  • Haematomas, commonly called bruises, are typically caused by injuries of the blood vessels during surgery. Meticulous haemostasis during a surgery is the best prevention. Haematomas may occur prior to an infection, increasing the risk of capsular fibrosis, and therefore should be avoided or treated immediately. Large postoperative haematomas may, if untreated, provoke extrusion or displacement of implants. Non-resorbable haematomas may require an immediate explantation.
  • Desensibilization or hypersensibilization: these may be temporary or permanent and may affect the whole breast or just part of it. There may be changes in sensibility in the presence of mammary implants, especially when a peri- or transareolar incision was made. 
  • Skin necroses and implant extrusions: skin necrosis is the premature death of tissue, and extrusion is the expulsion of the implant through skin. They may occur due to excessive tension of the skin overlaying the implant (e.g. oversizing the implant in relation to the space or accelerated tissue extension by means of a breast expander) or by interrupted or reduced skin vascularization (e.g. traumatization of skin flap during the surgical intervention). Treatment with steroids may also provoke necroses. Smokers are high-risk patients as blood circulation in the overlaying skin may be impaired. Revisions may be necessary.
  • Delayed wound healing: The healing period varies from patient to patient depending on the type of surgery and the placement of the incision. In some patients, especially smokers, a significant delay in wound healing may occur. Delayed healing increases the risk of infection, extrusion and / or necrosis.
  • Atrophy of the breast tissue: The skin covering the implant may thin due to the tension under which it is placed. Reoperation may become necessary.
     
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Undesirable aesthetic outcomes:

  • Implant visibility may occur when using too large implants, as well as with subglandular placement and insufficient tissue coverage.
  • An unsatisfactory result in terms of shape or size can be minimized by careful surgery planning, but cannot be ruled out. A revision surgery can help, but it brings new risks.
  • Asymmetry: Breasts appear uneven in size, shape, and / or position. It is possible that preoperative asymmetry can not be fully compensated by the use of implants.
  • Ptosis: relaxation of the breast tissue due to gravity, pregnancy, weight loss and aging.
  • Wrinkling: visible wrinkles on the implanted breast may be due to an overly large pocket or inadequate positioning of the implant.
  • Displacement: Displacement may be due to improperly sized or placed implants. 

Complications related directly to implants:

  • Implant ruptures are absolute indications for an explantation. Damaging of the implant (intraoperatively, e.g. by too short incisions, by surgical instruments, or postoperatively, e.gin case of punctures, biopsies etc.), traumata 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 unity. After a rupture the implant should be exchanged.
  • Permeation of silicone: all modern breast implants are equipped with special barrier layers, however the passage of low molecular silicone components through the shell of the implant cannot be completely excluded. Normally, the small amounts of gel remain within the tissue capsule that physiologically grows around the implant. Granulomas of unknown genesis are an indication for a biopsy or for explantation.
  • Swelling of the axillary lymph nodes.
     

Systemic diseases and cancer:

  • Autoimmune and connective tissue diseases: a possible connection between these diseases and mammary implants has been discussed since the 1980s. To date, there is no proof that breast implants cause such diseases.
  • Cancer risk: epidemiologic studies of women having implants reveal that breast cancer risk for them is not higher if compared with control groups. 
  • Anaplastic large cell lymphoma (ALCL): ALCL is currently classified as a rare form of non-Hodgkin's lymphoma (NHL). It typically presents itself as a late seroma containing atypical cells. Several investigations have shown a possible link between breast implants and the development of ALCL. This means that women with breast implants may have a small increased risk to develop ALCL. Patients should be informed by their responsible surgeon about an existing low risk for ALCL and advised to consult their attending physician if seromas or symptoms such as swelling and pain in the implant region occur more than one year postoperatively. The NCCN Guidelines have been approved concerning BIA-ALCL: these indicate how to diagnose and treat the disease. Early diagnosis and timely treatment lead to a positive prognosis.   

Breast feeding:

  • Breast implants and infants: There is no evidence that breast implants could be detrimental to the health of infants.
  • Breast feeding impairment: The ability to breast feed may, irrespective of breast implants, be affected by breast surgery. Make sure to discuss your wishes and expectations concerning possible motherhood with your surgeon.
     

Expanders:

  • Deflation of breast expanders: if the recommended 6-month implantation period is exceeded, the expander shell may fold – as a possible side-effect of the expansion phase – and this in turn may weaken the shell and lead to the deflation of the expander.
  • Overfilling of expanders: overfilling an expander may lead to ischaemia and other complications (e.g. necrosis, extrusion). The amount to which an expander is filled should be adapted to individual patient conditions.
  • Permeation of saline solution: silicone elastomers are permeable to gas, steam and saline solution. Permeation of saline solution through the expander shell may cause a loss of liquid and a decrease of volume.
     

Source:

1. ISAPS 2017 Global Statistics:

https://www.isaps.org/wp-content/uploads/2018/10/2017-Global-Survey-Press-Release-Demand-for-Cosmetic-Surgery-Procedures-Around-The-World-Continues-To-Skyrocket_2_RW.pdf

2. Handel, N., “Long-Term Safety and Efficacy of Polyurethane Foam-Covered Breast Implants”, Aesthetic Surgery Journal, Volume 26, Issue 3, 1 May 2006, Pages 265–274.

3. Pompei, S., et al., “Polyurethane Implants in 2-Stage Breast Reconstruction: 9-Year Clinical Experience”, Aesthetic Surgery Journal, Volume 37, Issue 2, 1 February 2017, Pages 171-176, doi.org/10.1093/asj/sjw183

4. Brand, K.G., “Infection of mammary prostheses: a survey and the question of prevention”, Annals of Plastic Surgery, 30 April, 1993, pp. 289-295.