February 21st, 2013 Dr. Mele
Allergan Natrelle 410 Breast Implants get FDA Approval.
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!
One of the first, if not the first, in the area to complete FDA mandated training on the use of Allergen’s Natrelle 410 Breast Implants.
October 28th, 2011 Dr. Mele
October - Breast Cancer Awareness Month
October was national breast cancer awareness month. The NFL celebrated with NFL Pink’s A Crucial Catch. By teaming up with the American Cancer Society, and by wearing pink caps and gloves, the focus is on the importance of annual screenings, especially for women who are 40 and older.
Who Gets Breast Cancer?
Worldwide, 1.5 million people are expected to be diagnosed with breast cancer in 2011. The importance of self-examination and mammograms cannot be overstressed. The earlier breast cancer is detected, the better the cure rates, and the smaller the need for mastectomy. Controversy in the timing and number of mammograms has been highlighted here on the San Francisco Plastic Surgery Blog, and as new technology and detection strategies develop, these recommendations will change. We will continue to add our voice to San Francisco Breast Cancer Awareness.
What Can a Plastic Surgeon Do?
Plastic surgeons usually get involved after the diagnosis of breast cancer is made. I have been involved on both sides of the stethoscope, personally and professionally. The diagnosis is made worse by not knowing what to expect. Once the diagnosis is made, and the plan is selected; however, being able to contribute with breast reconstruction can be a big positive.
What Options Are Available for Breast Reconstruction?
Breast reconstruction in 2011 consists of two main options: Breast implants or breast flaps. Breast reconstruction with a breast implant is often begun at the time of mastectomy. The advantage of this immediate reconstruction is the ability keep a breast mound despite the mastectomy. Sometimes the reconstruction is better delayed until after the initial other treatments like chemotherapy or radiation.
Breast flaps include local rearrangement of skin, fat and even muscle from the abdomen and back, as well as microvascular transplantation. These operations can also be either immediate or delayed. They require additional surgical time and the healing of a “donor site”, but can avoid some of the complications associated with a breast implant.
What’s on the Horizon for Breast Reconstruction?
New technologies are also being explored. Fat and stem-cell grafting are being explored as “less invasive” methods of breast reconstruction, but these still remain controversial and should only be performed as part of a well planned and IRB reviewed investigation until more is known.
Another novel method involves a little of all the above. An Australian company, Neopec, uses a temporary implant, a flap of fat and a special gel to enhance cell growth, in an attempt to fill the space created by the implant and eventually form a new breast mound made of the patients own fat cells.
Breast Cancer Awareness Month – All Year Long
While it is nice to help restore that which is lost, it is better to treat breast cancer early before a mastectomy is necessary. So as Breast Cancer Awareness month draws to a close, and we continue to Walk for Breast Cancer and Race for the Cure, please remember your mammogram and to do a brief monthly self breast exam for the other eleven moths too.