Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Spring renewal of breast implant PMA debate

This article was originally published in The Gray Sheet

Executive Summary

FDA General & Plastic Surgery Devices Panel will convene in April to review supplemental data on Inamed's silicone gel-filled breast implants, the firm says Dec. 6. Submitted to the agency in August, the data supports a PMA deemed "approvable with conditions" by the FDA panel in a 9-6 vote last year (1"The Gray Sheet" Oct. 20, 2003, p. 3). FDA's rejection of the PMA in January narrowed the race between Inamed and Mentor, which claims it expects a spring panel review of its own silicone implants. Like Inamed, Mentor filed supplemental data to its PMA in August, accounting for FDA guidance in January. The two firms could share a panel date...

You may also be interested in...



Silicone breast implant panel

Inamed and Mentor will go before FDA's General & Plastic Surgery Devices Panel April 11-13 in Gaithersburg, Md., according to both firms (1"The Gray Sheet" Dec. 13, 2004, In Brief). In addition, Mentor will bring its implants before Health Canada's Expert Advisory Panel March 3-4; Inamed likely will share the date. The Canadian meeting will be closed to the public [Editors' note: Visit "The Gray Sheet" affiliate FDAAdvisoryCommittee.com to view the FDA panel meeting live, or to order a DVD or videocassette]...

Inamed Silicone Implant Patient Monitoring Plans Allay Rupture Concerns

Inamed's proposal to closely follow patients implanted with silicone gel-filled breast prostheses helped sway FDA's General & Plastic Surgery Devices Panel to recommend conditional approval of the firm's PMA by a 9-6 margin

Bharat Biotech Plans Coronavirus Vaccine

After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.

UsernamePublicRestriction

Register

MT021319

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel