Some alternative breast implants have the same silicone elastomer shell that surrounds a saline-filled or silicone gel-filled implant. Other types have shells consisting of a different chemical composition. The filler in an alternative breast implant may or may not consist of a gel.

No alternative breast implant is FDA approved.

These implants were removed from the market in 1991 because the polyurethane foam coating released a toxic material called TDA. In some patients undergoing explantation, the entire polyurethane foam coating was no longer present because it dissolved into the tissue.

Toxic hydrolysis product from a biodegradable foam implant

Exposure to toluenediamines from polyurethane-covered breast implants

Urinary excretion of free toluenediamines in a patient with polyurethane-covered breast implants

Polyurethane coated implants return to the market in the UK (2005)

Trilucent breast implants contain soybean oil that is surrounded by a silicone elastomer shell. They were never FDA approved but were permitted to be used in a study in 1994. They were approved in the United Kingdom until 1999, when the Medical Device Agency removed them from the market due to concern that the filler could degrade into a carcinogen. At explantation, the shells of Trilucent breast implants showed degradation caused by the lipid in the filler weakening the shell.Lipid bleed throughout the implant shell also occurred. Problems with anterior and posterior patch delaminations made the implant prone to rupture. Soybean oil in Trilucent implants prostheses underwent peroxidation, yielding aldehyde by-products in concentrations that were over 1000 times that thought to be potentially genotoxic.

The history of Trilucent implants, and a chemical analysis of the triglyceride filler in 51 consecutively removed Trilucent breast prostheses.

What exactly was wrong with the Trilucent breast implants? A unifying hypothesis.

Hydrogel-filled breast implants

Hydrogel breast implants consist of a silicone elastomer containing hyrogel filler. Hydrogels are polymeric materials that swell in water without dissolving and retain water in their structures.Two models were on the UK market including PIP Hydrogel breast implants and NovaGold breast implants. In December 2000 the MDA issued two Device Alerts regarding the withdrawal of hydrogel-filled breast implants. Adverse events included breast swelling associated with fluid around the implants and capsular contracture.

The material damaged the health of rabbits in laboratory experiments.

Long-term results of MISTI gold breast implants: a retrospective study

China bans hydrogel for breast implants

Future Options for Breast Augmentation in the U.S.

Studies on this breast implant are currently being conducted in the United States. The cohesive silicone gel-filled implants are available in other countries. In Europe they have been utilized for the past ten years.

Cohesive gel is a form of silicone that is semi-solid. The shell of this implant is made from silicone rubber. According to the manufacturers of these implants, the shape and position of the cohesive gel implants are not likely to change over time and silicone gel supposedly does not leak from the shell if it is disrupted; however, one case report published in 2006 has described complications occurring with cohesive gel including silicone granuloma formation in the implant capsule and silicone lymphadenitis.

Locoregional silicone spread after high cohesive gel silicone implant rupture

Leakage and silicone lymphadenopathy with cohesive breast implant.

Cohesive gel-filled implants may be more useful in reconstructive surgery because of the density but women seeking breast augmentation for cosmetic purposes may not prefer to have this type of implant. Also, the shell of this implant contains silicone and other chemicals which may cause complications.

Titanium-coated breast implants

These breast implants are filled with cohesive silicone gel and coated with titanium. The titanium is covalently bonded to silicone but the body only comes in contact with titanium. According to the manufacturer, titanium is supposedly biocompatible so a reaction of the body to the implanted material is unlikely to occur. Reoperations are less likely to be needed when augmentation is performed with this type of implant.

P.E.G. Implants

A new implant containing a filler that is composed of saline and polyethylene glycol may be an option for breast augmentation in the future. Patent Discovery Corp., a company in San Francisco has obtained the rights to the new breast implant from the University of Texas Southwestern Medical Center in Dallas.

Stem Cells

Stem cells, which are cells capable of becoming different types of cells (i.e. fat cells), may be used in the future for breast reconstruction and augmentation. This process involves extracting adipose tissue and concentrating its stem cells. The amount extracted is twice as much fat as is required for the implant. Half is treated to separate out the stem cells. These are then added back into the remaining fat to be injected into the breast in a series of treatments. Some stem cells form more fat and others develop into a living blood supply for the new tissue which can grow into the surrounding breast.

Hyaluronic Acid Injections

Macrolane, a product by Q-Med, is available in the UK as a method to temporarily enhance the breasts. The treatment involves injecting the breasts with a thick filler made from hyaluronic acid, a synthetic substance used for a long time in facial fillers. A local anaesthetic is used to numb the breasts before the procedure, then a thick needle is injected deep into the breast. The result lasts 12-18 months.

Macrolane FAQ

1. What is Macrolane™?

Macrolane - the first body shaping treatment using hyaluronic acid. It is based on Q-Med's unique patented NASHA™ technology (Stabilized Non-Animal Hyaluronic Acid) which has been used in over 9 million treatments in over 70 countries worldwide. Use of NASHA has been clinically proven and well documented in facial aesthetics for over 10 years

2. What is NASHA™?

Stabilized, Non-Animal Hyaluronic acid (NASHA) is unique to Q-Med, manufacturers of Macrolane. Naturally occuring hyaluronic acid (HA) undergoes a process where less than one percent is stabilized to form a permanent three-dimensional HA network without damaging the original chemical structure. This stabilization process produces a biologically degradable NASHA gel that carries minimal risk of allergic reaction or transmission of infectious substances and enables a longer durability.

3. What are the benefits of Macrolane to patients?

Market research has shown there to be a significant number of women who would like to adjust the shape of their body in a natural, non-permanent way that does not involve the use of implants or body fat in a major surgical procedure. Many women are also very hesitant about undergoing general anaesthesia or being left with a scar. With Macrolane, the procedure is short and requires only local anaesthetic and minimal time away from work or after-work activities.

4. What are the treatment indications for Macrolane?

Macrolane is an innovative product currently indicated for volume restoration and shaping of body surfaces, for example, the calves and buttocks. Macrolane can also even out discrepancies in the skin surface, for example, those caused by liposuction and surgical scars.

5. Can Macrolane be used for facial aesthetic treatments?

No, Macrolane is a specifically formulated NASHA gel that gives increased volume. as a result it should only be used for volume restoration and shaping of body surfaces.

6. Can Macrolane VRF be used for breast shaping?

Use of Macrolane in the breast is currently available under the body shaping indication. Ongoing research is being conducted to further evaluate the efficacy of Macrolane in the breast and improve breast shaping injection techniques. Q-Med, the manufacturer of Macrolane is committed to continuous research and development with patient safety a high priority.

7. Will Macrolane adversely affect the efficiency of mammograms and / or breast tissue?

Patient safety is a priority for Q-Med and undertaking scientific research to provide reassurance for women undergoing mammography following breast shaping with Macrolane has been a paramount consideration. In January 2008, at a major aesthetics meeting, a poster presentation representing the findings of a group of highly respected surgeons, all very experienced in the use of Macrolane in this indication, concluded that;

"The presence of Macrolane in the breast does not compromise the detection, diagnosis or management of breast disease"1

8. How is the Macrolane treatment performed?

General anaesthesia is not required and the procedure can be carried out in a clean environment similar to minor surgery, only requiring between 30 and 90 minutes depending on the site and quantity of gel injected.

9. How can I find a Macrolane expert?

Only physicians whom have undergone specific Macrolane training, provided by Q-Med, can use Macrolane. It is important that you ask to see their training certificate to check that the physician is able to carry out your treatment.

10. How long does Macrolane last?

Macrolane is intended to last for 12-18 months. Each individual treatment programme will include a yearly top-up as required to maintain optimal treatment results.

11. What will a treatment with Macrolane cost?

Treatment cost is dependant on the area treated and the amount of product used. Typically an initial breast shaping treatment using 200ml (100ml for each breast) will cost in the region of £2800 with follow top up treatment in a year's time in the region of £1400, but the cost of the top up treatments is likely to decrease because less product is needed over time to sustain optimum results.

1 Breast Augmentation with Stabilized Hyaluronic Acid Gel of Non Animal Origin: Visualisation of Tissue Behind the Implants - Mangnus Tengvar, Per Heden, Michael Olenius (Poster presented at IMCAS January 2008).