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At least 1,297 records · Page 72Linked to original sources
PubMed1994

Silicone breast implant litigation (Part 1).

Silicone breast implant litigation has escalated in the past couple of years with the Food and Drug Administration (FDA) investigation of silicone gel implants which resulted in finally removing the silicone gel implants from the market. Plaintiffs have linked various medical problems to the presence of silicone in the body. The FDA has stated that there is no medical evidence that silicone causes autoimmune disease. Silicone has never been shown to cause breast cancer. Breast implants can result in complications such as capsule contracture, gel bleed, implant rupture, calcifications around the implants, and possibly interference with mammography in the diagnosis of breast cancer. Plaintiffs have claimed that the implant manufacturers knew of the defects in the silicone shell implant covering, and covered up the facts. The product liability action has become a class action, and a proposed settlement has been made in terms of which implant recipients with any problems will be reimbursed. Furthermore, there will be coverage for future implant problems over the next 30 years. There will still be some litigation by those patients who have opted out of the settlement agreement.

Breast Implants↗
PubMed1993

Clarion cochlear implant: phase I investigational results.

Under phase I of an FDA-approved Investigational Device Exemption (IDE), six patients at the University of California, San Francisco (UCSF) have been implanted with the Clarion, a new multichannel, multiprogrammable cochlear implant system. Over a period of 5 years, the Clarion has been collaboratively developed by UCSF, the Research Triangle Institute (RTI) of North Carolina, and the device manufacturer and sponsor, MiniMed Technologies of Sylmar, California. For UCSF, it represents the culmination of 21 years of cochlear implant research. The Clarion incorporates the 16-contact electrode array developed at UCSF. This electrode is designed with a gentle curve and an elastic memory that allow it to hug the modiolar wall of the scala tympani. In addition, the electrode has mechanical features that prevent it from rotating upward and injuring the basilar membrane. One of the innovations necessary to allow broad clinical application of this device has been the development of an electrode insertion tool to assist the surgeon in safe placement. In each of the six UCSF cases, the insertion tool was used and electrode placement was achieved with ease. With the availability of a variety of speech processing strategies, the Clarion has also provided the opportunity for all of the patients tested to date to achieve some degree of open-set, auditory-only speech recognition. Surgical considerations and preliminary audiologic data demonstrate that the design rationale and objectives of the Clarion have been met.

Aged↗
PubMed1995

Perspectives on the U.S. FDA Bioresearch Monitoring Program.

An overview is presented of the U.S. FDA Bioresearch Monitoring Program from the field perspective. The presentation includes current insight as to how FDA conducts field audits in various program areas and observations regarding shared responsibilities for ensuring both quality data and patient safety during the preclinical and clinical investigation processes.

Clinical Trials as Topic↗
PubMed1995

[Standards, guidelines and principles for clinical trials: medical products].

In addition to existing legislation there have been valid european and international Good Clinical Practice (GCP) guidelines and standards for the planning management and evaluation of clinical research projects and of clinical investigation of medical products since the 1990's. GCP regulates patient protection, the responsibilities of the sponsors, information management, data processing and quality assurance. The Draft International Standard (ISO/DIS 14155) and the European Standard (CEN/EN 540) stipulate the prerequisites and conditions for the clinical testing of medical products and devices. The essential documents for any research or investigative project include the trial protocol and the investigator's brochure. Observation of the guidelines and standards must be emphasized chiefly for reasons of publication suitability and the international recognition of the research and development findings.

Clinical Trials as Topic↗
PubMed1995

Conduct of an internal review as part of the Application Integrity Policy.

This article reflects the authors' experiences in the conduct of a third-party internal review of a device manufacturer as part of the Application Integrity Policy. The experiences are discussed in terms of recommended operational procedural issues from the vantage point of the sponsor and consultant(s). Issues pertaining to the sponsor, such as employee cooperation, work priorities and responsibilities, the assembly of data to be audited, and the need to have an orientation program for the consultant(s), will be discussed. Likewise, issues pertaining to the consultant(s), such as their expertise, the need for a clearly defined audit plan and work assignments, the handling of interpersonal conflicts if they arise, and the content of the audit report, will be discussed.

Consultants↗