Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Breast Reconstruction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689871
• Other study ID #: 020056
• Status: Completed
• Phase: N/A
• First received: June 2, 2008
• Last updated: October 6, 2014
• Start date: January 1999
• Est. completion date: August 2011

Study information

• Verified date: January 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction
• Revision of Augmentation or Reconstruction

Intervention

Device:
• Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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 — View 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; discussion 17S-18S. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Complications	By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts	10 years	Yes
Secondary	Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied	10 years	No