Advanced Art of Cosmetic Surgery     Thomas M. DeWire, Sr., MD, FACS    Specializing in Cosmetic Plastic Surgery     Richmond, Virginia, USA

 

Leaning-breast-BLK.jpg (2581 bytes)         Advanced Art of Cosmetic Surgery     Thomas M. DeWire, Sr., MD, FACS    Specializing in Cosmetic Plastic Surgery     Richmond, Virginia, USA

Breast  Surgery Procedures

Breast Augmentation Mammaplasty with Silicone Implants

Important Information concerning the Release of Silicone Implants

 

Important Information Regarding Silicone Implant Augmentation: 

 

Silicone Breast Implant release for limited general use was announced by the FDA on November 17, 2006 following a near total ban that began February 1, 1991. I am one of the principal investigators in the Mentor Core Gel Silicone Study, a 10 year effort to assess silicone implant safety and efficacy, that led the FDA to the decision regarding silicone implants.  If you are contemplating silicone implants, it is important to understand  that the release is not free and unrestricted, as with saline implants, but rather it comes with several restrictions and obligations on the part of the surgeon and the patient.

 

FDA restrictions, warnings and requirements regarding silicone implants for cosmetic breast enlargement:

This list of FDA-mandated precautions regarding silicone was posted in November 2006, immediately after the FDA's release of silicone implants, and in response to the FDA requirement that these issues be discussed with patients prior to choosing silicone. Note well that these statements are those of the FDA, and not my personal view as an investigator in the Silicone Core Gel Study.  As noted below, many of the statements seem to show bias against silicone, and some seem completely unfounded in my estimation. Nonetheless, in response to the FDA requirement, the following statements are reproduced, with parenthetical comment, as appropriate:

Silicone breast implants are permitted by the FDA for the following uses

Breast Augmentation for women at least 22 years old including primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of previous breast augmentation.  (I have no idea of the rationale for the arbitrary age of 22 yrs.-TMD)

Breast Reconstruction including primary reconstruction to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction includes revision surgery to correct or improve the result of an original primary breast reconstruction surgery.

Breast implants (silicone or saline) are not considered lifetime devices. (Eventually the implants will fail, and require replacement---TMD)

Additional surgeries will likely be needed (such as to replace a ruptured implant--TMD)

According to the FDA, when implants are replaced, the risk of future complications increases compared to first time surgery. (Dr DeWire's comment: This may reflect the complex nature of the problem that led to the replacement or revision.)

The FDA recommends screening MRI breast exams (sophisticated imaging studies done by radiologists, but not entailing use of x-rays) starting 3 years after silicone implant placement, and every 2 years after that, and if rupture is noted on MRI, the implant must be removed/replaced. (Dr. DeWire's comment:  MRI exams can be expensive and are likely not going to be covered by insurance due to the cosmetic nature of the investigation in augmentation patients, although insurance coverage for reconstructive patients is a possibility. Further, MRI is very sensitive in detecting rupture, that is it will rarely miss a true rupture, but MRI  is not equally accurate, in that only about 85% of detected "ruptures" actually represent a ruptured implant, and thus about 15% represent false positive findings, with no actual rupture.  That is problematic in the event of reoperation for rupture detected by MRI, and requires careful pre-operative counseling.  )

Rupture of silicone gel-filled breast implants are most often silent (i.e., no symptoms are experienced by the patient and no physical signs of changes with the implant are evident most of the time)

According to the FDA, the sensitivity of plastic surgeons familiar with implants to diagnose rupture by physical exam alone is 30%, versus 89% by MRI scan.  (Somehow the FDA has decided that physical exam to determine rupture of a silicone implant is not even as accurate as a coin-flip---TMD)

Breast implants may interfere with breast feeding (Dr. DeWire's comment: this is mainly an issue if implants are placed via a peri-areola (nipple) incision)

With any implant, routine screening mammography will be more difficult, and more views are needed. (see:  http://www.advanced-art.com/Breast-Aug-Over-Under.htm and the mammography links at the bottom of that page)

Routine monthly breast self-exam should be performed by all patients (Dr. DeWire's comment:  This is true for all women, whether or not they have implants, and I am amazed by how many of my patients admit that they do not perform self-exam at all, or perform it only infrequently)

According to the FDA, changes to a patient's breasts are irreversible when implants are placed (Dr. DeWire's comment:  In my experience, this is mainly an issue when oversized implants are used, irreversibly stretching the skin and support tissues, or when implants have been placed over the muscle, leading to ongoing tendency to stretch the skin, producing ptosis or sag)

According to the FDA, patient health insurance premiums/coverage may be negatively affected by placement of silicone implants (Dr. DeWire's comment:  In my experience this has been rare, but you should check this fact with your insurance carrier to be sure, especially since rules are vastly different from region to region, and from insurance plan to insurance plan--I am not sure how this will be impacted by the Affordable Health Care Act)

According to the FDA, patients with silicone implants should make that fact known to any doctor who treats them, as it is an important part of medical/surgical history

According to the FDA, scar firmness around an implant (capsule contracture) should not be treated by closed capsulotomy (squeezing the breast to break the scar), as that can lead to implant damage or rupture.  (I agree with this statement---TMD)

The FDA agrees that smoking may interfere with healing after surgery (Dr. DeWire's comment:  smoking certainly significantly increases the risk of development of capsule contracture and unpredictably of healing, thus potentially leading to asymmetry of breast shape and geometry, and potentially causing the need for revision procedures.)

An FDA-approved information brochure "Important Information for Augmentation/Reconstruction Patients About Mentor MemoryGel™ Silicone Gel-filled Breast Implants" (60 pages) must be reviewed and signed by all patients who seek silicone implants and a copy of the signed brochure must be kept in the patient records along with surgeon's signature and attestation. This brochure reviews the Mentor Core Gel Silicone Study, in which Dr. DeWire was a principal clinical investigator, and which led to the FDA approval of Mentor's silicone gel implants as both safe and effective. Risks and benefits of silicone implants are reviewed in the brochure, as well as various obligations and information concerning silicone gel breast implants. This information is an important part of establishing patient understanding of silicone implant risks and benefits, and is an important facet of informed decision making and consent. This brochure should be downloaded from the link above and should be read and understood well before the consultation so that informed questions can be posed and answered at consultation.  An example of the acknowledgment of informed decision is found via this link: Informed Consent Acknowledgment

The FDA considers alternatives to breast augmentation to include:

  • do nothing and live with your present status as an alternative to breast augmentation
  • use saline implants as an alternative to silicone implants

According to the FDA ,surgery should not be scheduled for at least 1-2 weeks after review of the brochure and appropriate consultation, unless earlier surgery is deemed necessary by the surgeon

The FDA will conduct yearly surveys of 50 surgeons who are major users of silicone breast Implants to assess compliance with the Informed Consent and record keeping requirements

Implant manufacturers will be required to maintain a registry of all patients who have opted to have placement of silicone gel breast implants, although patients may opt to refuse submission of personally identifiable information (name, address, SS#). Nonetheless, the FDA strongly urges compliance by all patients with entry into the implant registry, should they need to be identified and supplied with any important or pertinent information in the future.

 

 

  IMPORTANT NOTE:

Patients who plan to seek silicone implant augmentation by Dr. DeWire at Advanced Art of Cosmetic Surgery should read and be familiar with all of the information presented above, and also should have completely read the FDA-approved informed consent brochure "Important Information for Augmentation/Reconstruction Patients About Mentor MemoryGel™ Silicone Gel-filled Breast Implants". prior to consultation, so that appropriate questions can be addressed at that time, in order to be fully informed prior to providing informed consent for silicone implant surgery.

 

Related  Breast Augmentation Links:   To Other photo Illustrated Procedures:

Important  Information  About  Implant  Breast  Enlargement

Trans-Axillary Breast Augmentation
Trans-Axillary Breast Incisions Scars
Breast Augmentation Shape Evolution
Breast Augmentation Shape Determination
Cleavage Determinants
Post-Op Implant Massage Technique
Implants Over versus Under the Muscle
Special Considerations in Augmentation
Breast Surgery in African American Women
Breast Augmentation FAQs
Breast Augmentation with Mastopexy or Breast Lift
Revision Surgery for Augmentation Problems
Important Information about Silicone Breast Implant Use
Nipple Reduction/Shaping
Mastopexy or Breast Lift

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Body Contouring

Facial Cosmetic Surgery

 Complex Augmentation Revision
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Thomas M. DeWire, Sr., MD, FACS
Advanced Art of Cosmetic Surgery
3974 Springfield Road
Glen Allen, VA 23060
Richmond, Virginia, USA
804-290-0200
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©Copyright 1997-2013  Advanced Art of Cosmetic Surgery:  Thomas M. DeWire, Sr, MD, FACS   Revised:   January 23, 2013 12:51 AM