BREAST IMPLANT SAFETY: RECENT REPORTS AND CONSIDERATIONS

29 Nov BREAST IMPLANT SAFETY: RECENT REPORTS AND CONSIDERATIONS

BREAST IMPLANT SAFETY:  RECENT REPORTS AND CONSIDERATIONS

November 29, 2018

Since 1986, I have performed cosmetic breast surgery with implants on over 4,000 patients.  While one might assume that an article written by a busy cosmetic surgeon would be to defend breast implants and downplay recent reports of injured patients, I hope to dispel that thought.  It would be disingenuous to declare that patient safety and patient health are not the overriding important issues.   After taking a careful look at recent reports of breast implant safety and studies that suggest safety concern with implants, I am writing this article to summarize my findings as objectively as possible.

Breast augmentation with implants began in the 1960’s.  The early breast implants were filled with a thin silicone that was well-known to “bleed” silicone particles through the shell of the implant. The complications of hard breasts (capsular contractures) were very common with reports of incidence as high as 50-60%.  Implant rupture was a problem, along with infections and collections of blood (hematomas).

By the early 1990’s, a small but very vocal group of women who felt that their medical issues were caused by their breast implants made their voices heard on the national media and to their congressmen, etc.  In 1992, increasing pressure from many sides led the FDA to remove silicone breast implants from the market, leaving only saline-filled (IV fluid) implants available. Injury claims related to silicone implants were rampant, and in 1995, Dow Corning, a large manufacturer of breast implants filed for bankruptcy.  Surgeons had only the saline implants for use in cosmetic cases.  Because many questioned the validity of the conclusions drawn from the FDA leading to the silicone implant removal from the market, many additional studies were performed to exam the data for “cause and effect.”  Autoimmune diseases were a primary concern with these implants, and this included rheumatoid arthritis, lupus, Sjogren’s Disease, and scleroderma, among others. On further review, in 1999 the Institute of Medicine reviewed the various studies of breast implant related problems. A panel of independent experts concluded that serious medical issues such as autoimmune disease, cancer and other systemic disease did, indeed, occur in breast implant patients, but at the same rate as the population in general who had no breast implants.  With this information in hand, implant manufacturers and plastic surgeons began a campaign to restore silicone implants to the general market. In November, 2006, the FDA cleared the newer generation, cohesive silicone gel implants to be placed on the general implant market.  For several reasons, these implants have become increasing popular with breast implant patients.  In the last decade, over 10 million women world-wide have received breast implants, with the great majority of those being cohesive silicone gel implants.  Recently there have been print articles and TV coverage of “injuries” supposedly caused by implants.  Issues such as hard breasts (capsular contractures), infections, hematomas (collections of blood), implant pocket asymmetries and others are well-known complications of breast implant surgery and often require another surgery to address.  While more incisions and recovery periods are expected, most rational people don’t consider these to be “injuries” to the patient, but rather complications that occasionally occur. The definition of “injury” being used in the articles and TV shows is simply anything requiring further surgery.  This is a very important point, because the recent article cites more than 8,000 injuries in breast implant patients.   However, further examination of the data shows that of these “injuries”, 84% are from saline implants, many of which were placed many years ago when silicone implants were banned.  A primary reason for re-operation with saline implants is deflation.  As the implants are filled with sterile IV fluid, there is nothing harmful to the patient related to the saline, but most patients with a deflated saline implant wish to have their implant replaced.  This obviously involves a return to the operating room. The complication of breast implant deflation is called an “injury” and included in the data presented in these articles. Doing simple math shows that of the more than 8,000 “injuries” reported, about 6,800 of those involved saline implants.  Also not mentioned is the percentage of the remaining 1,300 or 1,400 “injuries” involving return to surgery for the other complications mentioned.

The real bottom line with this discussion is an objective determination as to the honest percentage of these so-called “injuries” that involve systemic diseases such as connective tissue disorders, and whether it is found that breast implant patients are more likely to develop these problems than the general population, who have never had breast implants.

I am anxious for objective, honest studies on these issues, and feel that if it is determined that silicone implants are associated with a higher risk of developing these medical problems, then the data should determine the relative safety of breast implants.  I think that it is important to mention that the FDA has reviewed the data presented recently in these articles and has determined that “it does not have evidence suggesting breast implants are associated with these conditions.”

Lastly, I want to discuss breast cancer and ALCL (anaplastic large cell lymphoma) as these are worrisome considerations to those who have already had breast implants as well as to those considering it.  Over the last thirty (30) years these have been many studies looking for any association between breast cancer and breast implants, and to my knowledge there has been no definitive evidence linking the two.  Because of the large number of breast implants placed (10 million patients world-wide just in the last decade) these studies have a large patient base to determine accurate data.

ALCL (anaplastic large cell lymphoma) has only been reported in the last few years.  This is a cancer linked to textured breast implants (we never use textured implants in our practice), and is quite rare.  There have been reports of a total of 615 cases world-wide and 12 deaths resulting from this rare cancer.  Most patients are cured of this lymphoma.  I have not seen a confirmed report of ALCL in patients with smooth-walled implants.

I know this is a long discussion, so I will summarize the issues and give my brief thoughts:

• Any determination regarding breast implant safety should be based on scientific research conducted in an honest fashion over a large patient base. Breast implant manufacturers           are in business for one reason – to be profitable. Even if they talk a big game, that is the bottom line.  Playing with the data should not be allowed.
• Hysteria should not be criteria for making determinations regarding implant safety.
• Any patient considering breast implants who has significant concerns about these reports should think about waiting until an honest factual determination has been made                            regarding implant safety. After all, this is an elective procedure that can be postponed indefinitely or forever.
• Patients who already have implants and who have no worrisome symptoms should be patient until further scientific data is available. Those who are concerned about an issue                   should address these with their surgeon.
• If you are considering breast implants, it is imperative that the surgeon conducts a full “informed consent” with risks and potential complications discussed fully, so you can make             an informed decision whether to have implants or not.
• The standards of care that surgeons must follow should always be based upon scientific data and not conjecture, hysteria or “doctored data.”
• If, after further studies the implants are shown to cause medical problems in some patients, I feel that the chips should fall where they may. If it means curtailing the use of silicone         implants because of safety concerns my feeling is that is just the way it is.   Patient safety and patient health should always be the most important consideration.