Breast Implant Safety

Myth #7 Silicone gel-filled breast implants are not available in the United States

Mentor — Tue, 30 Jan 2007 02:12:10 GMT

FACT: The FDA recently approved Mentor’s MemoryGel™ silicone breast implants for use in breast reconstruction and augmentation patients.

Mentor’s silicone gel-filled breast implants first became available in the United States in April 1984. In January 1992, at the FDA’s request, Mentor agreed to a voluntary moratorium on sales of silicone gel-filled breast implants. In July of the same year, these medical devices were made available once again to reconstruction and revision patients who were willing to participate in an Adjunct study. The Mentor Adjunct Study has been one of the largest continued access studies, with more than 128,000 patients participating.

The data collected in Mentor’s Adjunct study was reviewed by FDA as part of the approval process. The silicone gel-filled breast implants that were recently approved by the FDA contain the same material as those that, prior to this approval, were manufactured and available only to physicians participating in the Mentor Adjunct Study.

Read more about the safety of breast implants, including links to various resources on the web.

Myth #6 Women with breast implants can’t have mammograms.

Mentor — Fri, 26 Jan 2007 01:30:43 GMT

FACT: Of course women with breast implants can have mammograms.

Special techniques developed for use in women with breast implants are available from appropriately qualified mammography technicians, so patients should inform their mammography technician when they have implants. FDA advises that if women are of the proper age for mammography screening, they should continue to undergo routine mammography screening as recommended by their primary care physician.

You may search for a Certified Mammography Facility from the FDA's website. This list of FDA Certified Mammography Facilities is updated weekly.

Myth #5 It is dangerous for women with breast implants to breastfeed.

Mentor — Tue, 23 Jan 2007 21:53:17 GMT

FACT: After several years of rigorous review by the FDA, and separate evaluation by an FDA Advisory Panel, FDA determined that these products meet PMA standards of safety and effectiveness. Mentor has worked closely with FDA to construct labeling (documentation) that will permit patients full, informed decisions when they consider the option of MemoryGel™ silicone breast implants. Mentor's labeling states that, although there are no current established methods for accurately detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone gel-filled implants when compared to women without implants (Lugowski, S.J., et al. 2000.) Analysis of silicon in human tissues with special reference to silicone breast implants. J.Trace Elem. Med. Biol. 14(1):31-42.

Myth #4 These silicone gel-filled breast implants are the same as the “dangerous” implants that were available in the 1970s and 1980s.

Mentor — Fri, 19 Jan 2007 01:36:56 GMT

FACT: Concerning the status of our third generation silicone gel breast implants, FDA has now spoken on the safety and effectiveness of these products.

Silicone gel filled breast implants have undergone changes in the last three decades to meet increasingly sophisticated consumer expectations.

The first silicone implants had very thick shells and contained a very firm silicone gel.
A second generation of implants with thinner shells and thinner gel was introduced in the late 1970s to address concerns of patients and physicians who believed that the implants were too firm, palpable and visible.
In the mid 1980s, concerns related to rupture rates of the thinner-shelled implants led manufacturers to introduce a third generation of implants. The shell of these implants was slightly thicker and contained a new low-bleed “barrier” layer. The gel was also adapted to be thicker. Today’s silicone breast implants are composed of a cohesive gel that is contained within a silicone elastomer shell.

Mentor's breast implant products have kept pace with the ever-evolving expectations of physicians and women who desire a soft silicone gel to retain the natural feel that resembles actual breast tissue.

Myth #3 A new generation of “Cohesive Implants” will soon be introduced that are better than those recently approved by the FDA.

Mentor — Wed, 17 Jan 2007 04:50:18 GMT

FACT: The current “third generation” of MemoryGel silicone breast implants, which have been in use for more than a decade, are cohesive. MemoryGel implants feature a soft, cohesive, gelatin-like substance that acts as a solid rather than a liquid. It holds together uniformly, while retaining the natural feel that resembles actual breast tissue. Other shaped products will be reviewed by the FDA in the future, but these products will have a firmer feel.

View a feature comparison of MemoryGel™ silicone gel breast implants and saline filled breast implants.

How long should I wait to resume exercise and other strenuous activities after breast implant surgery?

Mentor — Mon, 15 Jan 2007 21:59:46 GMT

FACT: Your doctor will be your best guide regarding how long you will need to remain off work and will advise you when and how to resume activities. Recovery periods vary from woman to woman. Generally the first few days are the most uncomfortable. The average time to return to full activities is four to six weeks.

It is important not to sweat into the incision while it is healing. Therefore curtail activity and sun tanning until after the incision is healed and sealed. Don’t over-do activity, especially of the upper body, too early. Let your body rest and heal. You want to minimize swelling around the implant.

Going into a Jacuzzi or bath after a month is usually ok. During the early time, one to two weeks following surgery, you don’t want to soak the incision.

Be sure you check with your doctor before returning to your workouts. Patients vary greatly in recovery times. Walking is generally recommended to encourage circulation. The larger the implant you receive the heavier the breasts will be. You should wear good support bras while running to minimize pull on the skin and ptosis (drooping) of the breast.

Myth #2 Saline-filled breast implants are safer than silicone gel-filled implants.

Mentor Corporation. — Tue, 05 Dec 2006 03:08:37 GMT

FACT: Both of Mentor’s silicone gel-filled and saline-filled implants have been approved by the U.S. Food and Drug Administration (FDA) for use in breast reconstruction and augmentation patients. The recent approval of Mentor’s MemoryGel™ products marks the first time since 1992 that silicone gel breast implants have been made available, outside of a clinical study, in the United States.

The MemoryGel™ approval came after the FDA reviewed Mentor’s pre-market application (PMA) and the FDA Advisory Panel positively recommended Mentor’s MemoryGel™ breast implants for approval. At the 2005 FDA Panel Meeting, Mentor presented results from its Core Gel MRI sub-study, which yielded a very low – 1.1% – overall confirmed and suspected rupture rate by implant for MemoryGel ™ implants at three years, and a confirmed rupture rate by implant of 0.3%.

Learn more about the differences between saline and silicone gel MemoryGel™ breast implants here.

Myth #1 Silicone gel-filled breast implants aren’t safe; they give people connective tissue disease.

Mentor Corporation. — Sat, 02 Dec 2006 03:19:28 GMT

FACT: After several years of rigorous review by the U.S. Food and Drug Administration (FDA), and separate evaluation by the FDA General Surgery and Medical Devices Advisory Panel, who provided input to the FDA, the FDA determined that these products meet pre-market application (PMA) standards of safety and effectiveness. Mentor has worked closely with FDA to construct labeling (educational literature) that will permit patients full, informed decisions when they consider the option of MemoryGel™ implants.

Click here to read a copy of Mentor's important information for breast augmentation and silicone gel MemoryGel™ implants.

Click here to read a copy of Mentor's important information for breast reconstruction and silicone gel MemoryGel™ implants.

FDA Breast Implant Questions and Answers

Mentor Corporation. — Sat, 02 Dec 2006 03:09:49 GMT

With the recent approval of silicone gel implants, such as the Mentor MemoryGel™, the FDA has updated their breast implant questions & answers area with new information.

You may be interested in reading some additional breast implant (and breast augmentation) FAQs, as answered by Diane Hart, RN and the nursing staff.