This study willbe used to collect short-term (5 year) data about possible health problems
associated with silicone gel implants. This data will be used to help see if the implants
are both safe and effective.
Breast implants have been used in nearly two million women for nearly 30 years. Although
there are side effects and risks of having silicone breast implants, most women who have
received them have had satisfactory results. Silicone gel breast implants are optional. They
are used because they offer more normal breast consistency to palpation and minimize the
possibility of ripple formation typically seen with saline breast implants. The advantage of
silicone gel implants over saline implants is purely cosmetic. There are no health benefits
to using silicone gel implants. All implants no matter what type require replacement
eventually. The Food andDrug Administration (FDA) is concerned that we do not know enough
about possible health problems from the silicone gel implants. The FDA has called for
detailed studies and has allowed silicone gel implants to be used in these studies while the
data is being collected. This study will be used to collect short-term (5 year) data about
possible health problems associated with silicone gel implants. This data will be used to
help see if the implants are both safe and effective.
- The patient a genotypical female
- The patient signed the Informed Consent Document prior to surgery
- The patient agreed to complete all required follow-up visits
- The patient wishes to participate in the Patient Registry, has agreed to conditions
of the Implant Registry and is willing to follow the requirements of the Registry
- The patient agreed to follow the explant analysis procedures in which case the
patient may be asked to authorize the sponsor to complete analysis on any study
device(s) which may require removal throughout the duration of the study?
- Based on general medical condition, medical history and psychological
appropriateness, the medical attending staff deemed the patient an acceptable
candidate for breast reconstruction?
- The surgeon deemed saline implants unsuitable for the patient Note: Patient
preference for silicone is NOT considered a medical condition.
- The patient must have at least one of the following breast conditions:
1. post-unilateral or bilateral mastectomy (immediate or delayed) as a result of
cancer or other disease process?
2. require reconstruction due to cancer treatments other than mastectomy
3. require revision due to complications or other undesirable results of previous
surgery for the above reasons
4. the patient post-trauma defined as total or partial removal of the breast(s)
through surgery (for any reason) or as a result of trauma itself?
5. the patient has congenital deformities defined as Pectus Excavatum. Poland's
Syndrome, or Pectus Carinatum
6. the patient require a reconstruction procedure, such as mastopexy, as the result
of severe ptosis?
7. the patient require revision with implant replacement due to severe deformity
caused by medical or surgical complications, regardless of original indication
for implantation or type of device originally implanted?
8. revision or replacement required for patients whose prior surgery was not the
result of treatment for cancer and for whom saline implants are unsuitable (e.g.
skin too thin, insufficient tissue, etc.) as deemed by the surgeon.
- If a change in implant size is to be made, the surgeon has determined the necessity
of the revision/replacement for medical reasons. If the size change is the only
indication for surgery, and no medical necessity, the patient is ineligible. i) the
patient requires contralateral mammaplasty in the unaffected breast as a result of
the affected breast requiring surgery
- The patient desires augmentation mammaplasty and does not have at least one of the
diagnoses identified in the inclusion criteria, question 8
- The patient has an abscess or infection anywhere in their body at the time of study
- The patient is currently pregnant or nursing
- The patient has been diagnosed as having lupus defined as Systemic Lupus
Erythematoses or Discoid Lupus, or scleroderma defined as progressive Systemic
- The patient currently has uncontrolled diabetes or any diseases which are clinically
known to impact wound healing ability
- the patient demonstrates tissue characteristics which are clinically incompatible
with mammaplasty (e.g., tissue damage resulting from radiation, inadequate tissue,
compromise vascularity, or ulceration)
- The patient possesses any condition or currently under the treatment for any
condition,which in the opinion of the investigator and/or consulting physician(s),
may constitute an unwarranted surgical risk
- The patient demonstrates psychological characteristics such inappropriate attitude or
motivation which, in the opinion of the investigator are incompatible with the risks
involved with the surgical procedure and the prothesis
- the patient unwilling to undergo any further surgery for revision (if required)