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McGhan Medical Silicone-Filled Breast Implant Adjunct Study

Open (Enrolling)
Breast Reconstruction With Silicone Implants

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Trial Information

McGhan Medical Silicone-Filled Breast Implant Adjunct Study

This prospective clinical study is being undertaken to document the safety of McGhan Medical
Silicone-Filled Breast Implants. Patients will be evaluated pre-operatively,
intraoperatively, and at one, three and five years following implant surgery. Safety of
McGhan Medical Silicone-Filled Breast Implants will be assessed based on the incidence of
medical complications, implant failure and serious adverse effects.

This prospective clinical study of McGhan Medical Silicone-Filled Breast Implants is part of
an ongoing research effort to document the safety and effectiveness of silicone-filled
breast implants.

Inclusion Criteria:

- Females of any age for which breast reconstruction is considered appropriate.
(Patients under 18 years old require parental/legal guardian consent to participate).

- Have any of the following conditions or situations present:

- Post mastectomy surgical removal of the breast for cancer or other diseases;

- Post trauma or post surgery where there was total or partial removal of the
breast resulting in significant deformity.(for any reason);

- Severe ptosis requiring reconstruction (i.e. mastopexy);.

- Any congenital or acquired discrepancy in breast size such as to represent a
significant physical deformity. This does not include normal variants of
asymmetry. Examples include, but are not limited to:Pectus excavatum, Pectus
carinatum; Thoracic hypoplasia (Poland's syndrome, Scoliosis; Isolated rib
deformities; Tuberous breasts; Congenital absence

- Revision of implant procedure due to any of the following circumstances;

- Previous augmentation or reconstruction with silicone- or saline-filled implants
where problems exist, such as implant. rapture or significant capsular contracture
(Baker Grade III or IV) requiring revision;

- Contralateral mammaplasty in unaffected breast as a result of the affected
breast requiring surgery (for one of the aforementioned circumstances), when
medically indicated to provide symmetry.

- Adequate tissue available to cover implants.

- Saline-filled implants are not an appropriate choice.

- Willingness to follow all study requirements, such as agreeing to all required
follow-up visits, and acceptance of the risks involved as indicated by signing of the
Patient Informed Consent document.

Exclusion Criteria:

- Advanced fibrocystic disease considered to be premalignant-without accompanying
subcutaneous mastectomy.

- Existing carcinoma of the breast, without mastectomy.

- Abscess or infection in the body at the time of enrollment.

- Pregnant or nursing.

- Have any disease, including uncontrolled diabetes; which is clinically known to
impact wound healing ability.

- Show tissue characteristics which are clinically incompatible with mammaplasty, such
as tissue damage resulting from radiation, inadequate tissue, compromised vascularity
or ulceration.

- Have, or under treatment for, any condition which, in the opinion of the surgeon, may
constitute an unwarranted surgical risk.

- Show psychological characteristics which, in the opinion of the surgeon, may be
incompatible with the surgical procedure and the prosthesis, such as inappropriate
attitude or motivation.

- Wish to have augmentation mammaplasty, but do not have at least one of the diagnoses
identified in Patient Inclusion Criteria item G #2, pages 7 & 8.

- Are not willing to undergo further surgery for revision, if medically required.

- Diagnosis of lupus or scleroderma.

- Replacement of saline-filled implants solely for a less than desirable cosmetic
outcome, such as wrinkling.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Evidence of breast implant complications

Outcome Time Frame:

10 years 3 months

Safety Issue:


Principal Investigator

Peter Cordeiro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 1998

Completion Date:

December 2013

Related Keywords:

  • Breast Reconstruction With Silicone Implants
  • breast cancer
  • breast reconstruction
  • silicone implants



Memorial Sloan-Kettering Cancer Center New York, New York  10021