“Gummy Bears” and Silicone-Gel Breast Implants

Attempts to improve breast size and shape, dating back to the late 1880s and involving implant materials such as ivory, glass balls, ground rubber, ox cartilage and sponges, have come a long way. Recent statistics from the American Society for Aesthetic Plastic Surgery (ASAPS) prove that enhanced breasts are no passing trend. From 2008 to 2010, breast augmentation was the most popular cosmetic surgery in the United States, although in 2011 liposuction led by a nose. If you have ideas about improving your own décolletage, you are in luck. The federal government spent more on breast cancer research in 2010 than on lung and prostate cancers combined according to the National Cancer Institute.

There’s a lot to consider if you’re thinking about getting breasts implants, including implant safety, size, feel and shape; your incisions; your downtime and recovery period; costs; surgical facility and how your augmentation will affect your family and social relationships. Now there’s something else to think about. If you’ve been following the news recently, you’ve probably seen articles about “Gummy Bear” breast implants.

These Gummy Bears are not eaten; they are implanted in the bosom. “Gummy Bear” is a flippant name for a medical device, but these silicone-gel breast implants are called “Gummy Bears” for a good reason. A plastic surgeon participating in implant trials got tired of comparing them to Jell-O. If you’ve ever cut Jell-O into squares, you know that it retains its shape rather than pooling. So do Gummy Bears.

Although the nickname lacks gravitas, this new generation of silicone-gel breast implants has some distinct advantages. Unlike saline and earlier versions of silicone implants, Gummy Bears have the integrity to maintain shape if cut into squares. They do not ooze and they are not liquid-filled. With earlier versions of silicone-gel breast implants, if you took a knife and cut open the implants, the clear gel inside would slowly create a puddle on the table. Newer silicone implants, along with Gummy Bears, holds its shape.

This is no small potatoes and here’s why: 1) in the event of a rupture, these implants will keep their shape, 2) the integrity of shape minimizes the chance of gel leakage, 3) they pass the “feel” test because they squish when pressed against another person (as in a hug) as opposed to providing resistance like saline implants.

FDA Approves “Gummy Bears”

In terms of protecting our health, the Food and Drug Administration (FDA) is the only game in town. They oversee items accounting for 24 cents of every dollar we spend, including most food products, human and animal drugs, medical devices and therapeutic agents. In mid-March of this year, the FDA gave the nod to Sientra to begin marketing Gummy Bear implants. Sientra in turn pledged to only provide breast implants to board-certified plastic surgeons, increasing the safety and efficacy of their implants.  This follows years of controversy regarding silicone-gel breast implants. If you’re interested in breast implants, you’ll want to know what the fuss was about.

History and Safety of Silicone-Gel Breast Implants

The FDA took silicone-gel implants off the market in 1992 because of fears that they could be linked to cancer and autoimmune and connective tissue disorders (such as lupus). At that time, implant manufacturers were not able to provide adequate safety data to eliminate these concerns. But the FDA didn’t entirely banish silicone gel implants. Instead, they approved Mentor’s and Allergan’s study protocol using these implants for women needing breast reconstruction and revision.

Cancer and other major diseases: In 1999, an exhaustive study by the prestigious United States Institute of Medicine (IOM) www.ncbi.nlm.nih.gov/books/NBK44792/ found, “Evidence clearly shows that silicone breast implants do not cause breast cancer or the recurrence of breast cancer. In addition, there is no evidence that silicone breast implants contribute to an increase in autoimmune (connective tissue) diseases. Moreover, the committee found no proof or significant evidence of the existence of a ‘novel’ systemic disease, as some researchers have claimed, caused by the presence of silicone implants.”

Further, the committee said that exposure to silicone from the breast implant is limited almost entirely to the implant, its capsule, and the tissue and lymph nodes immediately surrounding the area. The committee also said that out of more than 1.5 million American women with silicone breast implants, it would be expected that some of these women would develop connective tissue diseases, cancer, neurological diseases, or other systemic complaints or conditions during their life. They concluded that, “Evidence suggests that such diseases are no more common in women with breast implants than in women without them.” In other words, “There is no evidence that silicone implants are responsible for any major diseases of the whole body.”

Breast feeding: If you are concerned about breast feeding, you’ll be interested that the IOM committee concluded that if you have silicone breast implants, “There are no dangers in breast-feeding; cows’ milk and infant formulas have a far higher level of silicon, a silicone component, than mothers’ milk. Breast milk is the best food for babies.” They urge mothers with breast implants to breast-feed their babies.

Mammography: Concerns about implants and mammograms arose in the 1960s and 1970s when both mammograms and silicone breast implants were in their infancy. Since then, both mammograms and implants have improved. Mammography now achieves more sophisticated imaging, and in 1988, a more advanced technique was introduced for manipulating the implant without compressing it. Although mammography may present some problems, the IOM committee recommends its use and notes that the procedure is quick and relatively inexpensive.

FDA Approval: Finally, in 2006 the FDA lifted its ban against using silicone-gel breast implants for breast reconstruction and augmentation. However, this approval came with the proviso that the FDA would continue monitoring 10-year mark studies of women who already had the breast implants and would require the completion of a second 10-year study of the safety of these implants in 40,000 other women.

Here are additional FDA stipulations attached to the 2006 silicone-gel breast implant approval:

  • The implants will not last forever
  • Many of the changes to your breasts following implantation are irreversible
  • Mammograms may require additional views and specialized facilities for analysis (Always inform your mammography center that you have implants when you make your appointment)
  • The best way to screen for rupture or leaks is to undergo MRI exams starting 3 years after implantation and every 2 years thereafter

Age Restrictions: If you’re a very young woman, you may be wondering if there are any age restrictions on breast augmentation and if restrictions differ between saline and silicone.The answer is “yes” and “yes.” Saline implants should not be used for augmentation in women who are under 18. Silicone implants are restricted to women who are older than 22. (However, both silicone and saline may be used for breast reconstruction in women of any age.) The age restrictions are based on the fact that breast tissue may still develop and change for several years after puberty, so there is concern that augmentation will be performed before full growth has occurred. The later allowable date for silicone may have to do with the FDA’s concern about long term follow up.

What to Expect From Silicone-Gel Breast Implants

All reputable medical institutions, including the FDA, will tell you that breast implants carry medical risks. First, you may need to replace your implants over time. Second, you can have local complications, including rupture of silicone gel-filled implants, deflation of saline-filled implants, contracture of fibrous tissue around the implant, infections, hematoma, pain and implant displacement that mean additional surgery or other medical interventions. If you have had a breast augmentation, you should periodically undergo MRI exams to screen for signs of either shell rupture or filler leakage.

Chances are that you will outlive your implants. The odds of having at least one replacement implant are high, and some women have had more. The IOM concluded that it is unclear whether implants in current use will need replacement in 10 or 15 years, as some older models did, or will last longer.

More About What Makes Silicone Different

Cohesive gel breast implants seem to hold their shape for a much longer time than other implants. Gummy Bears, composed of exactly the same ingredients as standard [silicone] gel, have more “cross-linker,” so the molecules bond better, creating a more form-stable shape. The gel is so thick that it won’t run or slosh around inside the implant. The folds and rippling associated with saline and silicone implants are less likely to occur with this stable-form implant. And, even if these cohesive gel implants do rupture, the silicone will not leak out.

Until now, FDA-approved silicone-gel breast implants have been round. With the approval of Sientra’s, you can choose a shaped implant. Your surgeon may recommend a shaped implant because it looks more like a natural breast. Sientra implants come in different sizes and have either smooth or textured shells. Ask your plastic surgeon about the advantages of each.

For Best Results, Do Your Homework

Both the FDA and ASAPS are confident that breast implants are safe and effective, but a procedure is only as good as the hands that perform it, so follow these rules:

  • Make sure your surgeon is certified by the American Board of Plastic Surgery
  • Make sure your surgeon has had adequate experience with the exact procedure you are undergoing
  • Even if your surgery does not occur in a hospital, make sure your surgeon has operating privileges to perform the surgery you’re undergoing in an accredited hospital
  • Make sure that the facility in which you undergo your procedure is accredited

For more information about breast implant safety, visit www.surgery.org and www.breastimplantsafety.org.