Clinical trial NCT01286870: Becker Continued Access Study
Official title: Continued Access Study of the Mentor Becker Expander/Breast Implant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Breast Reconstruction
Keywords: Primary Breast Reconstruction
Lead sponsor: Mentor Worldwide, LLC
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device.

Up to 12 patients per month at sites across the United States will be enrolled in this research study. These patients will be implanted with the Becker 25 or Becker 50 Expander/Breast implant and monitored for 10 years for safety.

Detailed description: Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Pre-market Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A pre-market approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.

In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision subjects. Every subject implanted had to be part of an adjunct study, in addition to being offered participation in a registry of gel-filled breast implant subjects. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an IDE clinical trial.

A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker Expander/Breast Implants.

The Mentor Becker Expander/Breast Implant was used throughout the United States during this time (since 1992) under the Mentor Adjunct Study to allow continued access to the device and to collect some safety information, however was not evaluated in the MemoryGel Core Study. The gel fill used in the MemoryGel implants is the same gel fill that is used for the Becker device.

This protocol describes the study design procedures and population for a Continued Access (CA) Study for the Mentor Becker 25 and 50 Expander/Breast implants. While Core Becker patient follow-up is being completed, this CA Study is designed to enroll patients at a limited rate per month to allow for continued physician experience with the device. The safety data obtained may be used to provide supplemental information to the PMA. It will be requested that this study be initiated and renewed every six months until a final decision is reached regarding the Becker PMA.

Eligibility criteria: Inclusion Criteria:

* Subject is genetic female, 18 years of age or older
* A candidate for primary breast reconstruction for cancer, trauma, surgical loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, or congenital deformity, including asymmetry (see Section 6.0 for definition)
* Signs the Informed Consent
* Agrees to return device to Mentor if explant necessary
* Agrees to comply with follow-up procedures, including returning for all follow-up visits
* Patient is a US citizen with a Social Security Number and understands English

Exclusion Criteria:

* Subject is pregnant
* Has nursed a child within three months of study enrollment.
* Been implanted with any silicone implant including breast implants (e.g. silicone artificial joints or facial implants)
* Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondylarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
* Infection or abscess anywhere in the body
* Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
* Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
* Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
* Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
* Premalignant breast disease without a subcutaneous mastectomy
* Untreated or inappropriately treated breast malignancy, without mastectomy
* Are HIV positive
* Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive
* Physician is intending to use the device for tissue expansion only

Primary outcomes:
measure: Safety by Incidence, Severity, and Duration of Adverse Events
timeFrame: 4 Years
measure: Safety by Method of Resolution of Adverse Events
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Mentor Worldwide LLC
state: California
Study officials:
affiliation: Binghamton, NY
name: Mark A. Walker
role: PRINCIPAL_INVESTIGATOR
References: