In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
The Focus Group study is a one time study designed to evaluate how easily patients
understand the information in the informed decision brochure about the risks associated with the use of slicone breast implants. A total of 35 women participated in one of four group interviewers for the study. Two discussion groups were conducted for women considering breast implants for augmentation and two group interviews were conducted with women considering breast implantssfor reconstruction. Each group was composed of eight to ten women. A trained female moderator led the discussion groups, which were each abouat 2 hours long. Respondents received a $150 honorarium in return for their time. Group interviewrs were conducted in a professional resaraevh facilities that alloesd for observation and audio recording.
Study Population Description
The study population is as per device indication. This device is indicated for breast augmentation
for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
35 women in one of each of 4 groups. Two were held in Dallas, Texas
and two in San Francisco, California. These sites were selected based on the volume of breast implant surgeries condcuted in these areas.
The study used two methods of data collection: discussion groups and a self-administered survey-- to
capture both group level and individual level data. A female moderator led each discussion group using a discussion guide prepared in advance by the contracted research firm with the assitance of Mentor Corporation. Two versions of the brochure were tested, one designed for augmentation patients and one designe for reconstruction patients. Endpoints included respondents' reactions to the overall layout oand format of the brochures, content ordering, and iollustrations and tables.. Data were collected on respondents' comprehesnion and perceived relevance of the content. Throughout the discussion, data were gathered on respondents' suggestions for improvements.