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

• Sponsor: Allergan Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00689871
• Collaborator: (none)
• Enrollment: 715
• Location: 1
• Arms: 4
• Duration (Months): 151
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation; Breast Reconstruction; Revision of Augmentation or Reconstruction	Device: Natrelle(TM) Silicone-Filled Breast Implants	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 715 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: Jan 1, 1999
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Primary augmentation	Device: Natrelle(TM) Silicone-Filled Breast Implants; Breast implant surgery
Experimental: 2 Primary reconstruction	Device: Natrelle(TM) Silicone-Filled Breast Implants; Breast implant surgery
Experimental: 3 Revision-augmentation	Device: Natrelle(TM) Silicone-Filled Breast Implants; Breast implant surgery
Experimental: 4 Revision-reconstruction	Device: Natrelle(TM) Silicone-Filled Breast Implants; Breast implant surgery

Outcome Measures

Primary Outcome Measures

1. Local Complications [10 years]

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

Secondary Outcome Measures

1. Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale [10 years]

   Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Washington	District of Columbia	United States

Sponsors and Collaborators

• Allergan Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan Medical
• ClinicalTrials.gov Identifier: NCT00689871
• Other Study ID Numbers: 020056
• First Posted: Jun 4, 2008
• Last Update Posted: Oct 13, 2014
• Last Verified: Jan 1, 2014

Study Results

Participant Flow

Recruitment Details	Enrollment: January 6, 1999-June 30, 2000 at multiple US sites

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction
Arm/Group Description	All women implanted for an indication of primary breast augmentation	All women implanted for an indication of primary breast reconstruction	All women implanted for revision of a breast augmentation	All women implanted for revision of a breast reconstruction
Period Title: Overall Study
STARTED	455	98	147	15
COMPLETED	280	46	74	8
NOT COMPLETED	175	52	73	7

Baseline Characteristics

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction	Total
Arm/Group Description	All women implanted for an indication of primary breast augmentation	All women implanted for an indication of primary breast reconstruction	All women implanted for revision of a breast augmentation	All women implanted for revision of a breast reconstruction	Total of all reporting groups
Overall Participants	455	98	147	15	715
Age, Customized (participants) [Number]
<=40 years	319 70.1%	10 10.2%	61 41.5%	0 0%	390 54.5%
Between 40 and 60 years	136 29.9%	73 74.5%	84 57.1%	9 60%	302 42.2%
>=60 years	0 0%	15 15.3%	2 1.4%	6 40%	23 3.2%
Sex: Female, Male (Count of Participants)
Female	455 100%	98 100%	147 100%	15 100%	715 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Local Complications
Description	By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

all enrolled patients

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction
Arm/Group Description	All women implanted for an indication of primary breast augmentation	All women implanted for an indication of primary breast reconstruction	All women implanted for revision of a breast augmentation	All women implanted for revision of a breast reconstruction
Measure Participants	455	98	147	15
Capsular Contracture	18.9	24.6	28.7	6.7
Breast Pain	11.5	6.8	11.7	0
Swelling	9.2	7.1	8.2	0
Implant Malposition	6.9	2.3	6.0	13.3
Nipple Complications	6.3	3.3	1.4	0
Hypertrophic/Other Abnormal Scarring	4.2	5.5	6.6	0
Asymmetry	3.3	23.2	6.5	6.7
Wrinkling	1.8	10.2	5.4	0
Implant Palpability/Visibility	1.6	6.4	6.0	6.7
Seroma/Fluid Accumulation	1.8	2.3	6.0	6.7
Bruising	0.4	1.0	3.0	6.7
Skin Rash	0.9	2.0	0.7	6.7

2. Secondary Outcome

Title	Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Description	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

All patients who had a breast implant satisfaction rating

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision-augmentation	Revision-reconstruction
Arm/Group Description	All women implanted for an indication of primary breast augmentation	All women implanted for an indication of primary breast reconstruction	All women implanted for revision of a breast augmentation	All women implanted for revision of a breast reconstruction
Measure Participants	279	44	74	8
Physician satisfaction	4.8 (0.7)	4.7 (0.6)	4.4 (1.1)	4.6 (1.1)
Patient satisfaction	4.8 (0.7)	4.6 (0.7)	4.4 (1.2)	4.5 (1.4)

Adverse Events

Arm/Group Title	Primary Augmentation		Primary Reconstruction		Revision-augmentation		Revision-reconstruction
Arm/Group Description	All women implanted for an indication of primary breast augmentation		All women implanted for an indication of primary breast reconstruction		All women implanted for revision of a breast augmentation		All women implanted for revision of a breast reconstruction
All Cause Mortality
	Primary Augmentation		Primary Reconstruction		Revision-augmentation		Revision-reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Primary Augmentation		Primary Reconstruction		Revision-augmentation		Revision-reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/455 (0%)		0/98 (0%)		0/147 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Primary Augmentation		Primary Reconstruction		Revision-augmentation		Revision-reconstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/455 (0%)		0/98 (0%)		0/147 (0%)		0/15 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The timing of separate presentation or publication of the study by the PI is subject to mutual agreement in advance between the Sponsor and PI.