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

NCT00689871 | Completed Results

• 1 other identifier: 020056
• Study Type: interventional
• Target: 715
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Augmentation; Breast Reconstruction; Revision of Augmentation or Reconstruction

Outcome Measures

Primary Outcomes (1)

• Local Complications

  By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts

  10 years

Secondary Outcomes (1)

• Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale

  10 years

Study Arms (4)

1

EXPERIMENTAL

Primary augmentation

Device: Natrelle(TM) Silicone-Filled Breast Implants

2

EXPERIMENTAL

Primary reconstruction

Device: Natrelle(TM) Silicone-Filled Breast Implants

3

EXPERIMENTAL

Revision-augmentation

Device: Natrelle(TM) Silicone-Filled Breast Implants

4

EXPERIMENTAL

Revision-reconstruction

Device: Natrelle(TM) Silicone-Filled Breast Implants

Interventions

Natrelle(TM) Silicone-Filled Breast Implants DEVICE

Breast implant surgery

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan Medical: lead

Study Sites (1)

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Related Publications (6)

• 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.

  PMID: 18090808 RESULT

• 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.

  PMID: 19092580 RESULT

• 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.

  PMID: 19158517 RESULT

• 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.

  PMID: 23559355 RESULT

• 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.

  PMID: 23664574 RESULT

• 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.

  PMID: 24867717 DERIVED

Limitations and Caveats

The Revision-reconstruction arm only had 15 patients enrolled, which makes the data for that arm difficult to interpret.

Results Point of Contact

• Title: Medical Monitor
• Organization: Allergan Medical

devicetrials@allergan.com

(805) 961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: January 1, 1999
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: October 13, 2014
• Results First Posted: January 23, 2012

Record last verified: 2014-01

Locations

US (1)