Seven years and 941 women later, Allergan has received FDA approval for its newest cohesive silicone gel breast implant. The Natrelle 410 Breast Implants are teardrop shaped, highly cohesive (gummy bear) implants that are approved for the cosmetic enhancement of breast volume in women 22 years or older, and for breast reconstruction at any age. Since the gel in these new breast implants is firmer, it retains its teardrop shape, but still gives when touched.
New Breast Implants Approved with a Condition
The approval comes with a condition. A breast implant follow-up study must be completed including 3500 women followed for 5 years and 2000 women for 10 years. Follow-up studies have been an FDA recent requirement for the approval of implantable devices, including previously approved breast implants.
What is a PMA Study, and Why They are Important?
I have been an investigator for the post-market approval (PMA) studies for all three US Breast Implant Manufacturers: Allergan, Mentor and most recently, Sientra. PMA studies are very important. They assure us that the new breast implants are as good as the pre-market research proved. The PMA studies also provide objective data that can be used to compare one type of breast implant to another. Larger numbers of participants also allow for the identification of the very rare occurrences.
Join a PMA study – It’s Less Than Free
PMA studies for breast implants carry no additional risk, and often include a small financial incentive to encourage continued participation. The amount is not enough to cover a Breast Augmentation, so it shouldn’t encourage anyone to get breast implants who wasn’t already considering the idea. However, the small financial carrots may help with the biggest problem encountered in long-term studies — people dropping out and becoming “lost to follow-up.”
Who is Eligible to Join?
PMA studies are designed to learn what happens after implantation. Participants are enrolled prior to surgery, and need to meet certain minimal requirements. The studies are closed once enough participants are recruited, and these participants will continue to be followed for the duration of the study (5 to 10 years). For Breast Implant Follow-up Studies, a yearly survey is completed in the comfort of your own home, and periodic follow-up examinations are performed in the office. Typically these are at 1, 5 and 10 years, though there is some variation.
Current PMA Studies with Open Enrollment
Currently, Sientra is enrolling new Breast Augmentation patients for the Sientra PAS (Post-Approval Study). It is named OASIS (Online Annual Sientra Implant Study). The PMA Studies for Saline and round Cohesive Silicone Gel Implants for Allergan and Mentor are closed; however, with the release of the 410′s a new PMA should be opening up. The investigators have not yet been selected. Stay tuned to the San Francisco Plastic Surgery Blog for more details!