Clinical trial NCT00689871: Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Breast Reconstruction
Revision of Augmentation or Reconstruction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 715
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.


Eligibility criteria: Inclusion Criteria:

* Female, age 18 years or older
* Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
* Seeking primary breast reconstruction
* Seeking breast revision-augmentation
* Seeking breast revision-reconstruction
* Adequate tissue available to cover implants
* Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

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 (e.g., HbAIc \> 8%), that is clinically known to impact wound healing ability
* Show tissue characteristics that 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 that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
* Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
* Are not willing to undergo further surgery for revision, if medically required

Primary outcomes:
measure: Local Complications
timeFrame: 10 years
Secondary outcomes:
measure: Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
timeFrame: 10 years
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
Study officials:
References:
citation: Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.
citation: Gladfelter J, Murphy D. Breast augmentation motivations and satisfaction: a prospective study of more than 3,000 silicone implantations. Plast Surg Nurs. 2008 Oct-Dec;28(4):170-4; quiz 175-6. doi: 10.1097/PSN.0b013e31818ea7e0.
citation: Murphy DK, Beckstrand M, Sarwer DB. A prospective, multi-center study of psychosocial outcomes after augmentation with natrelle silicone-filled breast implants. Ann Plast Surg. 2009 Feb;62(2):118-21. doi: 10.1097/SAP.0b013e31817f01f8.
citation: Largent JA, Reisman NR, Kaplan HM, Oefelein MG, Jewell ML. Clinical trial outcomes of high- and extra high-profile breast implants. Aesthet Surg J. 2013 May;33(4):529-39. doi: 10.1177/1090820X13484035. Epub 2013 Apr 4.
citation: Namnoum JD, Largent J, Kaplan HM, Oefelein MG, Brown MH. Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1165-72. doi: 10.1016/j.bjps.2013.04.046. Epub 2013 May 9.
citation: Spear SL, Murphy DK; Allergan Silicone Breast Implant U.S. Core Clinical Study Group. Natrelle round silicone breast implants: Core Study results at 10 years. Plast Reconstr Surg. 2014 Jun;133(6):1354-1361. doi: 10.1097/PRS.0000000000000021.