trending Market Intelligence /marketintelligence/en/news-insights/trending/yJXTNwRFjoeudsHlG0o_dA2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

J&J, Sientra get FDA warning letters over study requirements for breast implants

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

J&J, Sientra get FDA warning letters over study requirements for breast implants

Johnson & Johnson and Sientra Inc. received warning letters from the U.S. Food and Drug Administration for failing to comply with requirements of certain approvals for their silicone gel-filled breast implants.

According to the FDA, J&J unit Mentor Worldwide LLC failed to enroll the required number of patients in the post-approval study for its MemoryShape breast implant. Further, the study had "significant data inconsistencies," and Mentor did not have sufficient follow-up rates with patients in the study.

Meanwhile, Sientra's post-approval study for its silicone gel breast implants had a "serious deficiency," with the company reporting a follow-up rate of 61%, which is below the target.

Mentor's and Sientra's implants were approved in 2013.

In the U.S., manufacturers of silicone gel-filled breast implants are required to conduct post-approval studies to evaluate long-term safety and effectiveness of the products. The regulator said failure to meet post-approval study requirements is a violation of the premarket approval order.

The FDA requested Mentor and Sientra, both based in Santa Barbara, Calif., to submit responses detailing corrective actions within 15 days.