3
5. Haematoma/Seroma
Haematoma/seroma may occur in the postoperative period inhibiting
wound healing, or have delayed onset, either of which may require surgical
correction and/or explantation.
6. Inflammatory Reaction
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 evidence
on the possible cause of the inflammatory reaction and treat the patient
correspondingly. It is advised not to replace the implant until the inflammatory
reaction has passed completely and its cause has been eliminated.
7. Extrusion
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.
8. Wrinkling and Folds
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.
9. Interference with Standard Mammography/Self-Examination
The patient should continue to perform regular breast examinations for
cancer screening; however, this may be more difficult with an implant.
The patient should be informed by the physician about the possible
interference of the implant on the self-examination of the breast.
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 radiation. 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.
10. Pain
As expected following any invasive surgical procedure, pain of varying
intensity 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
discomfort, 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.
11. Breast Feeding and Sensation
Sensation in the nipple and breast can increase or decrease after implant
surgery, is typically lost after complete mastectomy where the nipple itself is
removed, and can be severely lessened by partial mastectomy. 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 sensation 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.
12. Dissatisfaction with Cosmetic Results
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 considerations
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.
Re-positioning of the implant during subsequent procedures should be
carefully evaluated by the medical team and care taken to avoid
contamination of the implant. Use of excessive force during any subsequent
procedure can contribute to localized weakening of the breast implant shell
potentially leading to decreased device performance.
13. Rotation
Rotation of an anatomical implant may occur. Proper placement and pocket
dissection reduces the risk of occurrence. Revision surgery may be necessary
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.
14. Ptosis
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.
15. Distortion
Tissue expansion is a time and labour intensive process that may cause
temporary discomfort and distortion. If distortion occurs, the cause should be
analysed and eliminated.
16. Calcification
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
necessitate surgical intervention.
17. Tissue Atrophy/Chest Wall Deformity
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.
18. Gel Diffusion
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.
Release Date: 29 Sep 2015 00:07:57 GMT -07:00
Expires one day from 21 Dec 2015
Effective
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