adverse event

Purpose: The purpose of this investigation is to test the safety and effectiveness of the Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic treatment of capsular contracture of the breast in conjunction with the Aspen Rehabilitation Technique. The hypothesis of the proposed study is that external ultrasound with the Aspen System™ device in conjunction with the Aspen Rehabilitation Technique is safe and effective in the reduction by at least one level of Baker Grade III capsular contracture in cosmetic breast augmentation patients, maintained at one year from the final treatment. Potential benefits of the study to subjects include improvement in the grade of capsular contracture of the breast without surgical treatment. The investigation is planned to last 12 months.

Protocol:

Objectives: Two stages are proposed for this study. In Stage I, the objective is to demonstrate the safety of the Aspen System™ and Aspen Rehabilitation Technique in the treatment of Baker Grade III capsular contracture of the breast following subglandular or submuscular placement of saline or silicone implants for cosmetic breast augmentation. The endpoint will be the determination of safety as defined by no adverse events, including implant rupture. Following review of interim data and approval by the FDA, Stage II will commence. In Stage II, the objective will be to demonstrate safety and efficacy of the Aspen System™ and Aspen Rehabilitation Technique in the treatment of Baker Grade III capsular contracture of the breast following subglandular or submuscular placement of saline or silicone implants for cosmetic breast augmentation. The endpoint will be the documentation of efficacy as demonstrated by the reduction of at least one Baker Grade following treatment with the Aspen™ System and Aspen Rehabilitation Technique.

Description: This is a prospective, non-randomized trial.

Conduct: The trial will be conducted as follows:

Study Subjects: Patients will be recruited from the investigator's private practice and the local community. In stage I, 10 women aged 22 years or older who have received saline or silicone breast implants for subglandular or submuscular breast augmentation, and who subsequently developed Baker Grade III capsular contracture, will be invited to participate. Upon completion of the first stage of this study, the data will be submitted to the FDA for review. The second stage of the study will not commence until approval has been obtained by the FDA. At this time, for the second stage of the study, the study group will be expanded to include an additional 50 patients who have received saline or silicone gel implants, placed in either the subglandular or submuscular position, with Grade III capsular contracture of the breast.

Inclusion Criteria:

Stage I:

• Age 22 years or greater,
• Cosmetic breast augmentation,
• Baker Grade III capsular contracture, subglandular implant position, saline implants.

Stage II:

• Age 22 years or greater,
• Cosmetic breast augmentation,
• Baker Grade III capsular contracture, subglandular or submuscular implant position, saline or silicone gel implants.

Exclusion Criteria:

• History of breast cancer,
• prior radiation therapy to chest wall,
• ruptured breast implant,
• calcification of capsules seen on any imaging study,
• implants > 15 years old,
• prior treatment for capsular contracture in past 12 months (open capsulectomy, open capsulotomy, implant exchange, implant plane change, placement of acellular dermal matrix, explantation, closed capsulotomy, or oral medication),
• metal implants,
• pacemakers,
• defibrillators,
• history of epilepsy,
• history of bleeding, and undiagnosed pain syndromes,
• pregnancy,
• currently lactating,
• acute and sub-acute thrombosis and thrombophlebitis,
• potentially malignant tumors,
• benign tumors,
• malignancy,
• third-degree musculotendinous lesions,
• multiple sclerosis,
• osteomyelitis,
• cardiac arrhythmias,
• acute sepsis of tissue or bone,
• arteriosclerosis,
• hemophilia, and
• sensory nerve damage.

Non-identified data may be made available to the FDA if requested.