Side effects and complications specific to breast enhancement surgery are rare, but may include: implant rupture/deflation, capsular contracture, infection, necrosis, haematoma/seroma, inflammatory reaction, extrusion, wrinkling and folds, interference with standard mammography, pain, breast feeding complications, change in breast sensation, dissatisfaction with cosmetic results, rotation, ptosis, distortion, calcification, tissue atrophy/chest wall deformity, gel diffusion, adulterated fill, inadequate tissue flap, and deformation.
Following is a description of these adverse events.
Gel implants may rupture, and saline or gel/saline implants may deflate at any time and require replacement or revision surgery. As ruptures are most often clinically silent, a radiological assessment may be required to aid diagnosis.
Causes of rupture or deflation include:
- Damage by surgical instruments; puncture of the valve may also occur from improper insertion of the fill tube for saline implants.
- Other trauma during surgery, such as improper handling or manipulation. For Natrelle™ 150 double lumen implants, Natrelle™ saline implants and Natrelle™ 133 tissue expanders, underfilling below the recommended fill volume range for the individual implant may result in folds, fold abrasion, and potentially, crease-fold failure; overfilling above the recommended fill volume range for the individual implant, which may compromise shell integrity.
- Capsular contracture, or abrasive calcifications in the fibrous capsule.
- Closed or external capsulotomy.
- Stressors such as trauma, intense physical activity, vigorous massage and/ or manipulation.
- Excessive compression during mammographic imaging.
- Leakage through remote port devices or through an unsealed or damaged valve.
- Umbilical endoscopic-assisted approach; preliminary reports indicate that there may be a higher incidence of deflation with this approach.
Long term Allergan Post-Market Surveillance data on single lumen and double lumen gel breast implants indicates a rupture rate between 0.17%-0.35%. Allergan US clinical study data on gel implants indicates a rupture rate of up to 4.5% at 7 years.
Long term Allergan Post-Market Surveillance data on single lumen and double lumen saline-filled breast implants, and tissue expanders indicates deflation rates between 0.19%-2.89%. Published results from Allergan US clinical study data indicated a deflation rate of 10.5% for saline implants at 10 years.
Formation of a fibrous tissue capsule around an implanted device is a normal physiological response. Fibrous capsular contracture remains a common complication following breast implant surgery and is one of the most com-mon reasons for reoperation. The cause of capsular contracture is unknown, however it is most likely multifactorial and may be more common following infection, hematoma, and seroma. Contracture develops to varying degrees, unilaterally or bilaterally, and may occur within weeks to years after surgery. Contracture of the fibrous capsular tissue surrounding the implant may cause a range of symptoms including firmness, discomfort, pain, distortion, palpa-bility, and/or displacement. Severe cases are considered the most clinically significant, and may require surgical intervention. Capsular contracture may recur subsequent to corrective surgical procedures. DO NOT treat capsular contracture by external compression or massage, which may result in implant damage, deflation, folds, and/or haematoma.
Infection around a breast implant may occur within days, weeks, or even years, after surgery. Signs of acute infection reported in association with implants include erythema, tenderness, fluid accumulation, pain, and fever. Erythema may also occur as a normal response to expansion. Infection that is unresponsive to treatment may require implant removal. Very rarely, Toxic Shock Syndrome has been reported as a possible complication of breast implant surgery and may also be associated with other types of implant sur-gery.
Necrosis may inhibit wound healing and require surgical correction and/ or explantation. Permanent scar deformity may occur as a result of necro-sis. Placement, expansion and pressure of the remote injection site (in the Natrelle™ 150) may induce necrosis particularly with unsuitable skin flaps.
Postoperative haematoma/seroma may inhibit wound healing and require surgical correction and/or explantation.
Studies evaluating the capsules around textured tissue expanders have reported possible silicone particles within giant cells, indicative of a local (and non-specific) foreign body reaction, and silicone granuloma formation. Another study suggests that certain types of capsule cells, including some perceived as giant cells, may actually be secretory cells that form in response to the frictional forces of the tissue expander, providing lubrication at the capsule-expander interface. In case of an inflammatory reaction, the surgeon is advised to remove the device from the patient’s body and to secure any evi-dence on the possible cause of the inflammatory reaction and treat the patient correspondingly. It is advised not to replace the implant until the inflamma-tory reaction has passed completely and its cause has been eliminated.
Unstable or compromised tissue covering and/or interruption of wound healing may result in extrusion of the implant. In case of an extrusion, the device should be regarded as contaminated and should be removed. It may be replaced with another device after the wound has sufficiently healed.
Palpable, or even visible, wrinkles and folds may occur (this may be caused by underfilling in the case of saline implants). Folds may result in thinning and erosion of adjacent tissue, and extrusion of the implant. Folds may also result in crease-fold failure and rupture/deflation of the implant. If wrinkling occurs, the device may be replaced with an implant with a different filler or shape.
The patient should continue to perform regular breast examinations for cancer screening; however, this may be more difficult with an implant. Patients should be instructed to inform their radiologists of the presence of an implant. With breast implants, routine screening mammography will be more difficult as the implant may interfere with diagnostic imaging. Because the breast and implant are squeezed during mammography, an implant may rupture during the procedure. More x-ray views may be necessary for women with breast implants; therefore, a patient may receive more exposure to radia-tion. However, the benefit of mammography is likely to outweigh the risk of the additional x-rays. Ultrasound may be a useful adjunct to mammography. Breast tissue imaging may be improved by submuscular placement of the implant. Orientation marks on anatomical gel-filled implants may be visible on mammographic images.
As expected following any invasive surgical procedure, pain of varying inten-sity and duration may occur following implantation. In addition, improper size, placement, surgical technique, or capsular contracture may result in pain associated with nerve entrapment or interference with muscle motion. Unexplained pain must be promptly investigated. In the case of tissue expanders, the expansion process may cause some dis-comfort, but should not cause excessive pain. Pain may indicate expansion beyond tissue tolerance, which could result in ischemia and necrosis. Further expansion should be discontinued until the pain is resolved.
Breast implants may impact the ability to breast feed, though there is no conclusive clinical study data to support this. The periareolar incision may be associated with a higher likelihood of breast feeding difficulties than other incision sites. The risk of temporary or permanent changes in breast sensa-tion resulting from breast surgery could interfere with the patient’s ability to breast feed. Nerve traction and compression have been reported in rare cases in association with tissue expansion. For saline implants, immediate partial deflation should be a standard precaution if nerve impingement is suspected, and filling should not resume until the problem is resolved.
Scar deformity, hypertrophic scarring, capsular contracture, asymmetry, displacement, incorrect size, unanticipated contour, palpability, and sloshing (Natrelle™ 150 and saline-filled implants), may occur. In some cases, cosmetic concerns may also lead to medical concerns. Careful surgical planning and technique can minimise, but not preclude, the risk of such results. Pre-existing asymmetry may not be entirely correctable. Revision surgery may be indicated to maintain patient satisfaction but carries additional considera-tions and risks. If the patient is dissatisfied with the cosmetic result, revision surgery may be indicated; the device can be replaced with another device of different height, width, projection, volume, shape or filling, or may be placed in a different position in order to achieve a cosmetic result which is more pleasing to the patient.
Rotation of an anatomical implant may occur. Proper placement and pocket dissection reduces the risk of occurrence. Revision surgery may be neces-sary to correct rotation. In case of rotation, it is advised to rotate the device back into its correct position in an open surgical procedure. Reshaping of the implant pocket may be necessary to avoid any further rotation in the future.
Ptosis occurs naturally in all breasts over time. In case of ptosis, a mastopexy may be performed and/or the device may be replaced by another product with a larger volume or greater projection.
Tissue expansion is a time and labour intensive process that may cause tem-porary discomfort and distortion. If distortion occurs, the cause should be analysed and eliminated.
Calcification commonly occurs in mature breast tissue with or without implantation. Microcalcification after implantation typically occurs on or around the fibrous capsule in thin plaques or accumulations. Extensive microcalcification may cause breast hardness and discomfort, and may neces-sitate surgical intervention.
Pressure of a breast implant or expander may cause tissue atrophy. In rare cases chest wall deformity has also been reported in association with the use of breast implants and tissue expanders.
Minute quantities of silicone may diffuse through the elastomer envelope of 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 unruptured, conventional gel-filled implants has been reported in the medical literature. However, there has been only limited evidence in medical literature associating gel diffusion with local complica-tions in breast implant patients. If significant gel diffusion occurs, the device should be checked for any possible leakage or flaws.
Do not use adulterated fill. Saline implants and tissue expanders are to be filled only with sterile saline for injection, and only as described in Instructions for Use.
Inadequate tissue flap following expansion may occur and may require addi-tional surgery and expansion.
The unique nature of the highly cohesive silicone implant may require a larger incision compared to the incision size required for other silicone-filled implants to avoid skin edge trauma or implant deformation. Excessive force upon insertion of the implant may compromise the precisely defined shape of the device, potentially leading to an undesirable cosmetic outcome.
Allergic reaction to anaesthetic
Nobody knows exactly how frequently anaesthetics cause allergic reactions. At the moment, the best estimate is that a life-threatening allergic reaction (anaphylaxis) happens during 1 in 10,000 to 1 in 20,000 anaesthetics. Your anaesthetist will choose the drugs for your anaesthetic by taking into account many different factors, in particular, the type of operation, your physical condition and whether you are allergic to anything.
Most people make a full recovery from anaphylaxis. It isn’t known how many anaphylactic reactions during anaesthesia lead to death or permanent disability. One review article suggests that 1 in 20 serious reactions can lead to death. This would mean that the chance of dying as a result of an anaphylactic reaction during anaesthesia is between 1 in 200,000 and 1 in 400,000 anaesthetics.
Nerve damage
It’s possible, but highly unlikely, that you could suffer nerve damage after a general anaesthetic. The size of the area may vary according to the nerves affected, from a very small patch of numbness, tingling or pain, to most of a limb. The pain can be a continuous, aching pain or a sharp, shooting pain. You may also get inappropriate warm or cold sensations. If motor nerves are damaged, there may be weakness or paralysis (loss of movement) of muscles in that area. The risk of a significant peripheral nerve injury lasting more than 3 months is estimated to be less than 1 in 2,000 patients having a general anaesthetic. Permanent damage, lasting more than a year, is estimated to occur in less than 1 case in 5,000.
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