2
RELATIVE CONTRAINDICATIONS/PRECAUTIONS
• Ptotic breasts where nipple falls below the inframammary fold, without
concurrent mastopexy.
• To varying degrees, radiation damage, ulceration, compromised vascularity,
or history of compromised wound healing which may affect tissue covering
suitability.
• Previous repeated contour correction failures.
• Patients about to undergo radiation therapy and/or chemotherapy as this
may make the use of breast implants and tissue expanders more difficult and
increase the risk of complications.
• Physiological condition determined by the surgeon to pose unduly high risk
of surgical and/or postoperative complications. To varying degrees, obesity,
smoking, diabetes, autoimmune disease, coagulopathy, chronic lung or severe
cardiovascular disease may affect patient suitability for surgical implantation.
INFORMATION THAT SHOULD BE PROVIDED TO THE
PATIENT
All patients should be informed of all the potential benefits and risks (see
WARNINGS below) associated with the procedure prior to surgery.
Expected benefits include facilitating emotional healing after cancer, eliminating
external prostheses, regaining body symmetry, allowing freedom in clothing and
physical activities, and improving sexual or interpersonal relationships.
Patients should be informed about the implant options available, the surgical
procedure including implant placement and incision site options. As this surgery
will most likely be carried out under a general anaesthetic patients should be made
aware of the risks associated with anaesthesia. Patients should discuss with their
surgeon any history which may indicate a contraindication (relative or absolute) to
surgery. Post-surgery care should be discussed, including time for wound healing,
the need for any drainage tubes, recuperation duration and the need for implant
integrity to be evaluated on a regular basis after primary surgery. Patients should
be advised to consult a physician or pharmacist before using topical medicines (e.g.
steroids) in the breast area, and if any clinical examination or surgery in the breast
area is planned the patient should inform the doctor or nurse of the presence of an
implant. The surgeon should advise the patient to consult a physician should she
suspect any complications. All patients should receive a patient information book-
let provided by Allergan.
Once the patient has received all the information, she should take at least 30 days
to think about the risks and benefits of having breast implants before making a
final decision.
WARNINGS
The surgeon should advise the patient that management of the complications listed
below may include additional surgery or explantation. Tissue expander patients
should be advised that tissue expanders are only to be used for a short term until
the tissue has expanded sufficiently.
Breast implants have a limited lifetime and the implant may have to be removed
or replaced which may necessitate revision surgery. Various factors, including the
type of implant inserted, the type of surgery, injury to the breast, and excessive
repetitive compression of the implant, may impact the longevity of the implants.
Details on the expected lifetime of the implants are presented in the Rupture/
Deflation section below. As many factors affect the lifetime of a device and are
outside the control of the manufacturer, the life expectancy of the implant cannot
be guaranteed. The surgeon should discuss the necessity of pre-screening mammo-
graphy with each patient as appropriate for her age and medical history.
1. Rupture/Deflation
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 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 over fourteen years
on single lumen and double lumen gel/saline breast implants indicates a
rupture rate between 0.37%-1.09%. Allergan US clinical study data on gel
implants indicates a rupture rate between 7.7% -9.7% at 10 years.
Long term Allergan Post-Market Surveillance data over fourteen years on
single lumen saline-filled breast implants and tissue expanders indicates
deflation rates between 0.267%-6.99%. Published results from Allergan US
clinical study data indicated a deflation rate of 10.5% for saline implants at
10 years.
2. Capsular Contracture
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 common
reasons for reoperation. The cause of capsular contracture is unknown,
however it is most likely multifactorial and may be more common following
infection, haematoma, 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,
palpability, 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.
3. Infection
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
surgery.
4. Necrosis
Necrosis may inhibit wound healing and require surgical correction and/or
explantation. Permanent scar deformity may occur as a result of necrosis.
Placement, expansion and pressure of the remote injection site (in the
Natrelle
®
150) may induce necrosis particularly with unsuitable skin flaps.
Do not use microwave diathermy in patients with breast implants. Microwave
diathermy has been reported to cause tissue necrosis, skin erosion, and
implant extrusion.
Release Date: 29 Sep 2015 00:07:57 GMT -07:00
Expires one day from 21 Dec 2015
Effective