Printer Friendly

FDA PROPOSES CALLING FOR DATA ON TESTICULAR IMPLANTS

 WASHINGTON, Jan. 12 /PRNewswire/ -- The Food and Drug Administration today proposed that manufacturers of testicular implants be required to submit scientific data to show that these products are safe and effective.
 Testicular implants, which are made of silicone, are intended for cosmetic purposes. They are commonly used to correct congenital abnormalities in infants and toddlers who are born without one or both testicles. They are also used in men who have had one or both testicles removed because of cancer or other diseases or who have lost one or both testicles due to injury. An estimated 1,000 are implanted yearly.
 "We need to make sure these devices are safe and effective," said FDA Commissioner David A. Kessler, M.D. "Therefore, we are proposing that companies submit data, just as we did for breast implants."
 Testicular implants are pouches that are placed in the scrotum. They are made of solid or gel silicone and have a silicone covering. Some types are coated with polyurethane foam.
 These implants were on the market prior to the Medical Device Amendments of 1976, which gave FDA regulatory authority over devices. Like other pre-amendment devices, testicular implants were allowed, under the law, to remain on the market with the understanding that FDA would later require manufacturers to demonstrate their safety and effectiveness.
 Although some information on the risks and benefits of testicular implants is available, there is not enough scientific evidence to determine whether the benefits outweigh the risks.
 The agency's safety concerns regarding the implants involve the lack of adequate information in these areas:
 -- The incidence of leakage, hardening of surrounding tissue and rupture. The silicone gel in these implants may leak into adjacent tissue, causing problems similar to those seen with breast implants.
 -- The long-term effectiveness of the implants. Reported problems of unknown frequency and origin include infection, pain, discomfort, erosion of the device and its migration to other parts of the scrotum and abdomen. It is also not known how often these complications require corrective surgery.
 -- The potential for long-term adverse effects, such as cancer, immune-related connective tissue disorders and reproductive problems. This type of information is particularly important because many of the implant users are young.
 -- The immediate and long-term psychological benefits of the implants, such as patient satisfaction and improved self-image and psychological outlook.
 If today's proposal is made final, manufacturers planning to continue marketing testicular implants will be required to submit a Premarket Approval Application demonstrating the safety and effectiveness of these products as a condition for keeping them on the market.
 FDA's call for safety and effectiveness data on testicular implants is part of the agency's ongoing review of pre-1976 devices. In addition to requiring safety and effectiveness data on silicone gel breast implants, FDA recently proposed calling for safety and effectiveness data on saline breast implants and will soon do the same for inflatable penile implants, heart bypass blood pumps and cranial electrotherapy stimulators.
 Today's proposal, which is being published in the Jan. 13 Federal Register, provides for a 60-day comment period. Comments may be submitted to Dockets Management Branch, HFA-305, Rm. 123, 12420 Parklawn Dr., Rockville, Md. 20857.
 FDA is one of the eight Public Health Service agencies within the U.S. Department of Health and Human Services.
 /NOTE: TV broadcasters please use open caption for the hearing impaired./
 /CONTACT: Sharon Snider of the Food and Drug Administration, 301-443-3285 or, after hours, 301-622-0977/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

IH -- DC017 -- 4007 01/12/93 12:15 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 12, 1993
Words:588
Previous Article:SCRIPPS INCREASES SUBSIDIARY OWNERSHIP
Next Article:FANNIE MAE ANNOUNCES REPURCHASED OR REOPENED SECURITIES DURING FOURTH QUARTER OF 1992
Topics:


Related Articles
FDA PANEL RECOMMENDS BREAST IMPLANTS REMAIN ON THE MARKET
FDA CALLS FOR TEMPORARY MORATORIUM ON SILICONE GEL BREAST IMPLANTS
FDA CALLS FOR A UNITED STATES MORATORIUM ON SILICONE GEL-FILLED BREAST IMPLANTS
CALIFORNIA PLASTIC SURGEON LAUDS UNITED KINGDOM DOCTOR'S STANCE ON BREAST IMPLANTS
FDA ANNOUNCES MEDICAL/DEVICE TRACKING PROPOSAL
FDA ANNOUNCES SILICONE BREAST IMPLANT DECISION
FDA COMMISSIONER ISSUES STATEMENT ON SALINE BREAST IMPLANTS
SALINE BREAST IMPLANTS -- CALL FOR DATA
FDA ANNOUNCES MEDICAL DEVICE TRACKING REQUIREMENTS
FDA raises bar for silicone breast implant approval: rejects advisory panel recommendation.

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters