Are Silicone Breast Implants Safe?

At Minneapolis Plastic Surgery, Ltd., we are committed to ongoing patient education and the provision of aesthetic plastic (cosmetic) surgery with a focus on long-term safety. As part of this commitment, our physicians and staff help patients thoroughly explore the details of breast enhancement with saline or silicone breast implants. We provide complimentary consultations at our Minneapolis / St. Paul area office. As leading Minnesota plastic surgeons, Dr. Richard H. Tholen and Dr. Douglas L. Gervais have the experience necessary to help you make informed surgical decisions. Both silicone and saline breast implants are FDA-approved.

History of Silicone Breast Implants

The modern era in breast enhancement began with the development and surgical implantation of silicone gel breast implants in a woman in 1963. In the 30 years that followed, plastic surgeons worldwide used silicone-gel-filled breast implants for both breast reconstruction and elective breast enlargement in well over one million women. Saline-filled breast implants were also used during this time, but in only about 15 percent of all patients undergoing breast augmentation.

Breast implants were developed and utilized for more than a decade before the FDA began regulating medical devices in 1976; the safe and effective use of silicone in these and other medical products such as pacemaker insulation, lubrication for insulin needles, chemotherapy tubing, and artificial joints was well-established before the FDA could evaluate all of them. Because silicone breast implants and many other silicone medical devices were already in use prior to 1976, the ongoing use of these products was “grandfathered” by the FDA without formal evaluation and approval. None of these other silicone medical devices has been restricted or made unavailable to patients, but lack of formal FDA evaluation and approval of breast implants came into public awareness in the early 1990s.

The lay media has been responsible for spreading a great deal of information and misinformation regarding breast enlargement in the past two and a half decades. Many women remember tabloid and TV talk shows’ focus on the supposed problems claimed to be associated with silicone gel implants. Despite a lack of scientific data supporting these concerns, in 1992 the FDA restricted the use of silicone gel breast implants in women requesting elective breast augmentation.

At no point have silicone gel implants ever been banned or “taken off the market,” but until November 2006 their use required enrollment in the FDA study that allowed only eligible patients and plastic surgeons access to them under strict guidelines. Since the FDA restrictions in 1992, numerous scientific studies (over 30 in the past decade) have continued to show NO cause-and-effect relationship between silicone gel breast implants and autoimmune-type illnesses (such as rheumatoid arthritis, lupus, scleroderma, or so-called “human adjuvant” diseases). Even after 1992, silicone gel breast implants have been used by plastic surgeons (including both Dr. Gervais and Dr. Tholen) involved in FDA-approved studies for patients undergoing breast reconstruction, breast augmentation revision (in certain patients), breast lift surgery, and for those patients with congenital breast deformities.

After exhaustive review of the previous nearly four decades of use, the FDA approved the use of saline-filled implants in May 2000.

Late in 2003, the FDA reviewed all of the available scientific data about silicone gel implants, including very detailed information from implant patients over the prior decade, and heard testimony from patients, physicians, and researchers. The expert physician advisory panel to the FDA voted to recommend that the FDA approve the use of silicone breast implants for primary elective breast augmentation. However, the FDA deferred its decision, requesting “additional information” before granting approval.

In spring 2005, the FDA again revisited the request by both of the existing implant manufacturers for approval of general use of silicone gel implants; the expert physician advisory panel recommended approval for Mentor Corporation’s gel implants. Late in 2005, Both Mentor and INAMED® (now Allergan) received letters of “[gel implant] product approvable” from the FDA.

On November 17, 2006 the FDA approved the use of silicone gel implants from both companies in patients over the age of 22, with certain restrictions, including involvement in the FDA study that has been ongoing for the past several years.

Opponents of silicone gel implants continue to claim that they cause autoimmune illness or are unsafe, but peer-reviewed scientific studies by many researchers and institutions have shown them to be safe and effective for their intended use. The controversy about silicone gel implants has made them one of the most intensely studied products in the entire medical marketplace.

As part of the 2006 FDA re-approval of silicone gel breast implants, each company has an informed consent booklet that you will be asked to read (and sign) prior to breast enhancement surgery. The FDA has made a controversial recommendation that patients with silicone gel breast implants undergo a MRI (magnetic resonance imaging, a non-X-ray study similar to a CAT scan) every two to three years to evaluate their implants (for leakage or rupture). Studies have shown that MRI evaluation of silicone implants has 79 percent effectiveness in detecting implant rupture or “leak.” Thus, if you have no identifiable problem or concern with your implants and choose to follow this recommendation, you will require an unnecessary re-operation (for entirely normal non-ruptured implants) 21 percent of the time! The FDA makes this recommendation because physician examination has been shown to be unreliable in detecting silicone implant rupture.

Yet, since present silicone implants are cohesive and cannot “leak,” this is a nonsensical recommendation, in our opinion, for women with latest-generation cohesive silicone gel implants. If you are not having any kind of problem or concern with your implants, it is ridiculous to perform a costly procedure (that may not be covered by your insurance) and an often-inaccurate test that would require an operation (erroneously) over 20 percent of the time. Rather, we believe that if you have any issue at all with your silicone breast implants (size, shape, position, firmness, or concern about possible implant damage), return to your breast surgeon for evaluation. We can then perform whatever corrective surgery is needed, where we will be able to examine, and replace if necessary, the implants under direct vision. Our plastic surgeons can offer substantially better than 79 percent accuracy with direct implant examination!

Implants and Breast Cancer; BIA-ALCL; Mammography

Numerous scientific studies have shown that augmentation mammoplasty does not increase the risk of developing breast cancer. Even without a family history of breast cancer, a woman has about an 11-12 percent risk of developing a breast cancer in her lifetime. If there is a maternal family history of breast cancer, these risks are higher. It is important to realize that while breast enhancement surgery does not increase the risk of developing breast cancer, it also does not reduce the risk. Whether or not a woman is undergoing breast enhancement surgery with silicone or saline breast implants, she must continue breast self-examination, physician examination, and mammography. If you have any concern whatsoever regarding your breasts, the Board-certified plastic surgeons at Minneapolis Plastic Surgery, Ltd. are always happy to perform breast examination and answer any questions; there is never a charge for consultation or recheck for any reason.

In early 2011, the FDA requested that health care professionals report confirmed cases of anaplastic large cell lymphoma (ALCL) in women with breast implants. The FDA reported that the scientific literature from January 1997 through May 2010 showed 34 unique cases of anaplastic large cell lymphoma (ALCL) in up to an estimated 10 million women with saline and silicone breast implants. These cases were most common in patients undergoing revision for late onset, persistent seroma.

As of September 30, 2018, the FDA has received a total of 660 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Of these, many MDRs were identified as duplicate reports, including additional follow-up reports. The filtered data showed 457 unique MDRs for BIA-ALCL, including 9 patient deaths. The FDA identified 334 reports that provided implant surface data. Of these, 310 concerned textured implants and 24 concerned smooth implants. All 457 reports included the implant fill type—274 reports on silicone gel-filled implants, and 183 reports on saline-filled implants. Thus, although rare, BIA-ALCL appears to develop more frequently in women with textured implants (regardless of fill) than in women with smooth-surfaced implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant; some cases have been treated with chemotherapy and radiation. Although the current lifetime risk of BIA-ALCL is estimated to be 1:3817 – 1:30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades, the incidence or prevalence of BIA-ALCL cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.

ALCL is lymphoma, NOT breast cancer, and some researchers have suggested that breast implant- associated ALCL may represent a new clinical entity with less aggressive behavior (Li, 2010; Miranda et al, 2009; Thompson et al, 2010). Despite favorable response to treatment in most cases, the FDA states that it is premature to draw conclusions regarding prognosis of BIA-ALCL. Despite the rare incidence of mortality with BIA-ALCL, there is significant morbidity and cost associated with this diagnosis and treatment.

The FDA also states that because the overall risk of ALCL appears very small, the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled. The FDA further states (as of 04-02-19) that “There is no need for women with breast implants to change their routine medical care and follow-up.”

Just several months later (July 24, 2019), the FDA requested an immediate recall of Biocell-textured implants and expanders from the marketplace, citing more recent data of 573 cases and 33 deaths from BIA-ALCL, up from the previous 19 deaths reported at the FDA hearing on March 25 and 26, 2019. Thus far, the FDA has not taken the step of banning textured implants, the most likely associated factor with BIA-ALCL. Very few, if any, credible reports exist to associate BIA-ALCL with smooth implants. At Minneapolis Plastic Surgery, we have not used textured implants for many years, and based on this data, presently choose to avoid their used altogether.

As of September 8, 2022, the FDA has received 10 MDRs (medical device reports) about squamous cell carcinoma (SCC) in the capsule (scar) that forms around breast implants, and 12 MDRs about various lymphomas (not the same as the ALCL discussed earlier) in breast capsule scars. The FDA indicates limitations of MDR data, including that reports do not necessarily represent unique cases. Though even more rare than ALCL data discussed earlier, incidence rate and risk factors are unknown, and the FDA indicates “This is an emerging issue and our understanding is evolving.”

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