Silicone Gel Breast Implants

Silicone Breast Implants Natrelle silicone-filled breast implants are indicated for females of 22 years of age and older. They include primary breast augmentation to increase breast size, as well as revision surgery to correct and improve the result of a primary breast augmentation surgery. They can also be used in breast reconstruction to replace breast tissue that has been removed due to trauma or cancer. Breast reconstruction may also include breast revision surgery to correct and improve the result of a primary breast reconstruction surgery.

Silicone gel implants are composed of dimethylsiloxane, which is a polymer of silicone. Silicone implants have been found to be safe by the FDA and have been reintroduced. In fact, leading researchers from around the world have confirmed the safety of the Natrelle silicone-filled breast implants, which is all supported by extensive pre-clinical testing in the United States. Dr. Linder uses silicone gel implants that come in three profiles, which includes Style 10 (moderate profile smooth round), Style 15 (mid-range profile smooth round), and Style 20 (high profile smooth round silicone gel implants).

Silicone gel implants have never been shown to cause cancer nor do they increase risk for autoimmune diseases. As a result, the FDA has reapproved them for the use in the majority of women over the age of 22. The contraindications of silicone gel implants include women with an active infection anywhere within their bodies, have existing cancer or pre-cancer of their breasts and have not received treatment, are currently pregnant or nursing, or are under the age of 22. According to Natrelle, precautions regarding safety and effectiveness with the use of silicone gel implants have not been completely established with patients who have:

1) autoimmune diseases such as lupus and scleroderma
2) a weakened immune system
3) conditions that may interfere with wound healing or blood clotting
4) reduced blood supply to breast tissue
5) radiation to breast following implantation
6) clinical diagnosis of depression or other mental health disorders, which includes body dysmorphic disorders and eating disorders, or any other history of mental health disease.

A seven year study of 455 patients with primary augmentation was conducted to determine the complications associated with silicone gel implants, which concluded with a 30.1 percent reoperation rate, a 15.5 percent capsular contracture (with Baker III or Baker IV scar tissue contracture) rate, 11.4 percent breast pain rate, and 9.2 percent swelling rate.

In addition, a study observing 147 revision augmentation patients found a 40.5 percent reoperation rate, 20.4 percent capsular contracture (Baker III or Baker IV) rate, 20.9 percent implant removal and replacement rate, and 10.6 percent breast pain rate.

Breast Implant Complications Chart

Chart provide by NATRELLE® Collections


Breast Implant Problems Chart

Chart provide by NATRELLE® Collections


Silicone gel breast implants require diagnostic testing, which includes an MRI every two to three years to detect a rupture of the shell or the implant bag. The integrity of the shell of silicone gel implants is difficult to determine during a mammography, and commonly, false-negatives occur. In other words, we have had patients with preoperative mammograms showing no rupture or loss of integrity of the shell of the silicone implant; however, intraoperatively have been found that the silicone shell was completely dissolved with loose, viscous silicone material throughout the breast. As a result, MRIs are useful and extremely sensitive for diagnosing solid ruptures or loss of integrity to the shell of the silicone implant. We recommend MRIs every three years for our patients. Silicone implants can migrate to the lymph nodes or other lymphatic structures within the body.

As taken from Allergan Pharmaceuticals' "Mending the Myths: Facts about Silicone Gel-Filled Breast Implants," five specific myths about silicone implants are noted from excerpts from Allergen Pharmaceuticals' website as follows:

  1. Safety of silicone products in the body. Silicone gel implants have been shown to be safely used in the body as well as for many different medical products and devices, which include joint replacement, heart valve, shunts, pacemakers, and of course, silicone and silicone shell implants.

  2. During routine mammography or exercising, it is significantly possible for silicone implants to rupture. This fact is a myth and according to Allergen Pharmaceuticals, it is very unlikely that silicone gel-filled implants would rupture during routine physical activity or a routine mammogram. The shells of the implants today are much stronger and thicker and "have been signed to withstand more than 25 times the force of a normal mammogram without failure." Allergan notes that saline and silicone implants are not lifetime devices and it is possible that some point in the patient's lifetime that the implants will need to be replaced or removed.

  3. Silicone gel implants may cause autoimmune diseases or cancer. The actual facts are that silicone gel implants are highly studied medical devices with thousands and thousands of peer reviews that have been published with epidemiological studies supporting their safe use. The numerous studies have shown that there is no evidence concluding that silicone gel will increase the risk of cancer, autoimmune diseases like rheumatoid arthritis, lupus, or any neurological diseases. In fact, "The National Institute of Health's Institute of Medicine (IQM) released a 400-page report in 1999 that was entitled Safety of Silicone Breast Implants, concluding that a review of toxicology studies of silicone and other substances known to be in breast implants does not provide a basis for health concern."

  4. Breast implants can grossly impact a mother's ability to breastfeed or lactate. According to Allergan Pharmaceuticals, the 1999 IQM Report has concluded there is no evidence of increased levels of silicone in the breast milk for women who have implants and it is not harmful to the infants. In fact, the Committee strongly concluded that mothers with silicone implants should attempt breastfeeding and stated that the evidence for health effects in children related to maternal breast implants is insufficient.

  5. Breast augmentation surgery may result in disproportionate or unnatural results. In general, women who undergo breast implant surgery have different views and different desires. In my practice, I like to proportion the patient as well as possible to their anatomical distribution. Allergan Pharmaceuticals or Natrelle has a variety of different implant sizes, shapes, textures, and fillers, for both saline and silicone, which due to the discretion of a Board Certified Plastic Surgeon can lead a woman to proportional and excellent results.

Silicone Safety Issues

In general, silicone is used every day in our active daily lives. Silicone is made from Silicon. This is an element that is found in sand, rock and quartz. Silicon is one of the most common elements in the earth's crust. It becomes silicone with a combination of hydrogen, carbon and oxygen. It has been used for over 50 years in the consumer's marketplace. Silicone has been used in multiple products, including moisturizing creams, lotions, suntan creams, hair sprays and even baby pacifiers. It is used in multiple devices in medicine, including artificial joints, facial implants, catheters, tissue expanders, valves and of course breast implants. Silicone is biocompatible, is easy to sterilize, it's flexible and it is very useful for implanting devices.

The history of silicone gel-filled breast implants from the 1970s to the present has been used in over 60 countries worldwide for reconstruction and augmentation mammoplasty procedures. In 1992, there was a moratorium in the United States of America on the use of silicone implants. FDA safety information and studies were then reviewed. Also, in 1992, the moratorium was lifted and allowed the silicone implants to be used selectively in reconstructive cases only. Furthermore, in 1999, breast augmentation and reconstruction studies were performed at the Allergan Clinical Studies through the Institutional Review Boards. Accumulation of data in order to determine efficacy and safety issues of silicone implants was collaborated and collected. In November 2006, the FDA reapproved silicone gel implants to be used in the United States of America.

Candidates for Saline versus Silicone:

Saline implants are very useful in patients with thicker chest walls and good ample amounts of breast tissue, because the rippling on the side is hidden by the lateral breast tissue. Silicone implants are useful for ectomorphic or thin women with minimal amounts of breast tissue, especially on the lateral breast. Although the implants are placed in the dual plane or subpectoral along the medial two-thirds of the pocket, the lateral third of the implant is normally only covered by breast tissue; this is where visibility and palpability of the bag edge is most common. Silicone implants are excellent for very thin women who have minimal breast tissue. High profile silicone cohesive gels are one of the best implants to reduce palpability and visibility of the implant edges.

GUMMY BEAR IMPLANTS

Gummy Bear Implants (Inamed Style 410 implants) are not FDA-approved implants at this time. They are cohesive silicone gel implants that may be useful in the future. The implants are referred to as the Inamed Style 410 implants. They were first created and brought to market in the early 1990s by Inamed Corporation. They are a more solid, thicker silicone cohesive gel material, less liquid form, thereby referred to as Gummy Bear Implants. They do not leak when cut in half and therefore may have less migration of silicone gel bleed as well as with extra capsular migration to lymph nodes.

The implants are useful for the fact that they maintain their shape and may be useful for women with very thin minimal massive breast tissue and thin tissue coverage. It may reduce visibility and rippling; however, so far studies have not shown that they completely reduce rippling altogether, especially in very thin ectomorphic women. They are an anatomical shape and are textured and thereby if the patient has any problems with rotational deformity, these may lead to severe disfigurement of the breasts. Again, they are not FDA-approved at this time. They are undergoing investigational studies and I do not recommend these implants at this time. They may be useful in the future and we will follow the clinical trials with Inamed, Natrelle and Allergan for their new cohesive style 410 Gummy Bear Implants in the near future. We will keep you updated as new information arises from this new product.

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Beverly Hills OfficeStuart A. Linder, M.D., F.A.C.S., Inc.

Phone: (310) 275-4513
Fax: (310) 275-4813
9675 Brighton Way, Suite 420 Beverly Hills, CA 90210

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