Clinical trial NCT00443274: Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms
Official title: Breast Implant Follow-up Study: A Long-term Observational Study of the Safety of Allergan Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms (410-arm)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Implant
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 56460
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast implants for augmentation, reconstruction, or revision of augmentation or reconstruction

Brief summary: Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.


Eligibility criteria: Inclusion Criteria:

Screening Criteria

1. Female

   1. age 18 years or older who is a candidate for breast reconstruction (primary or revision) with Allergan silicone implants or saline breast implants (controls) OR
   2. age 22 or older who is a candidate for breast augmentation (primary or revision) with Allergan silicone implants or saline breast implants (controls)
2. Exhibit fluency and literacy in English or Spanish

Enrollment Criteria

1. Have satisfied all the inclusion and none of the exclusion criteria
2. Have completed the implant surgery
3. Have only one breast implant or have matching breast implants (i.e., both Round Responsive, both Style 410, or both saline) following their qualifying surgery. In the case of silicone, the device(s) must be manufactured by Allergan.
4. Are free of all target diseases at baseline (410 arm only)
5. Have signed the informed consent form, documenting agreement to participate in all required follow-up interviews by internet, phone, or mail and authorizing health care providers to release medical records to study personnel, and have completed the baseline questionnaire prior to implant surgery (prospectively enrolled subjects)

For retrospectively enrolled subjects into the 410 arm, in addition to the above, these criteria also apply:

1. Received 1 or 2 Style 410 implants between 2015 and 2019
2. Willing to complete baseline questionnaire at time of enrollment

Continuation Criteria (BIFS Arm Only)

1. Have completed baseline and years 1, 2, 3 and 4 follow-up questionnaires available (including the Satisfaction with Breasts and Psychosocial Well-Being modules of the BREAST-Q)
2. Met all enrollment criteria, specifically the minimum age requirements for silicone implants (18 or older for reconstruction subjects and 22 or older for augmentation subjects), and were free of all target diseases at baseline
3. Were enrolled at a site that was selected in the cluster sampling to continue in the BIFS arm

Exclusion Criteria:

1. Are transgender
2. If a saline implant subject, have a current or past unilateral or bilateral silicone gelfilled breast implant
3. Investigator decision that subject is not a suitable candidate for a long-term observational study

Primary outcomes:
measure: Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator
timeFrame: 10 Years
measure: Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator
timeFrame: 10 Years
measure: Re-operations
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Southwest Plastic Surgery /ID# 240510
state: Texas
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References:
citation: Singh N, Picha GJ, Murphy DK. Natrelle Silicone Breast Implant Follow-Up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 50,000 Augmentation Subjects. Plast Reconstr Surg. 2016 Jan;137(1):70-81. doi: 10.1097/PRS.0000000000001851.