Maybe Now is the Time to Lift the Ban on Silicone Breast Implants

Suzanne Sims, MD, George D. Lundberg, MD


April 02, 2001

Scientific Literature Since the Ban

Since that time, numerous studies have been published in peer-reviewed journals analyzing the relationship between silicone breast implants and various systemic diseases. The great majority of this literature that we have found has not documented an increased risk of breast cancer,[9] connective tissue diseases,[15,16,17,18] or rheumatologic symptoms[15,16] in women who have silicone breast implants. One recent study, published in March 2000, concluded, "the elimination of breast implants would not be likely to reduce the incidence of connective tissue diseases."[19]

Given that much of the evidence now available directly contradicts the concerns that inspired the FDA to place its moratorium in 1992, why should not the FDA now lift the moratorium? The issue is a complex one. One of us opined in 1993 that this situation was a classic conundrum at the interface of ethics and law.[20] Kessler argued in 1993 that the Medical Device Amendments of 1976 require the FDA to evaluate the risks and benefits of implants on the basis of submitted data and studies from manufacturers.[21] The FDA did not have sufficient data from the manufacturers in 1992 and, as a result, decided that silicone breast implants could not legally qualify for FDA approval.[21] As mentioned above, evidence now exists that alleviates concern about the risk of systemic disease, the main publicized concern at the time and the belief that motivated court action.

Silicone breast implants have raised other concerns. Research and advocacy groups, backing away from their claims of systemic disease, are now focusing on the local complications of breast implants (Dr. Marcia Angell, Dr. Diana Zuckerman, personal communications, January 2001). These include capsule formation and contracture, implant rupture, infection, and silicone gel migration. Indeed, Dr. Kessler in his moratorium speech in 1992 did mention implant leakage, rupture, and capsular contracture as FDA concerns,[1] though these were perhaps not the most publicized.

Some studies have been conducted on local complications. Many show an average age of recognized silicone implant rupture (failure) at 13 years. However, studies have shown conflicting results as to whether implant failure was directly related to duration of implant[22] or type of implant (second generation, ie, thin-shelled, non-"low bleed" having a higher failure rate).[23] Studies have shown rupture rates to be 50% to 60% in silicone implants 10-15 years old,[24] with one study showing a failure rate of 6% per year for the first 5 years, 50% at 10 years, and 70% at 17 years.[22] Twenty-one percent of women in one study, following implant rupture, had silicone gel migration out of the fibrous capsule of scar tissue that surrounds the breast implant.[24] These studies utilized MRI, which has been shown to be 74% to 94% sensitive and 85% to 98% specific in detecting implant rupture.[24] How should the FDA view these risks to recipients of silicone breast implants?

While some women experience pain and granuloma formation with implant rupture, one of the studies of implant rupture was done in asymptomatic women who did not suspect their implants were ruptured; yet MRI confirmed that they were.[24] Thus, it is possible for ruptured implants to not have any adverse symptomatic health risks in some women. Unfortunately, there are no studies directly comparing silently ruptured implants to health risk over time, as it is often difficult to pinpoint the exact time of rupture. It would be important to know if and when ruptured implants should be removed, as there are known risks of surgery as well.

However, silicone gel implants are not alone in the possible need for additional surgery. Saline implants are also associated with risks for contracture, infection, and deflation, all of which may require additional surgery.[25,26] In addition, saline implants are encapsulated in a silicone shell. And saline implants never faced a moratorium and were recently approved by the FDA on May 11, 2000 for both reconstructive and cosmetic augmentation.[27]

In addition, most local complication rates (contracture, infection) are considerably less for augmentation patients then they are for postmastectomy patients.[3,5,28] For example, one study showed 12.5% of augmentation patients had a complication at 5 years compared with 30.4% of reconstruction patients.[28] Thus, preventing augmentation patients from obtaining silicone implants while allowing them for mastectomy patients does not make sense.

People take surgical risks routinely for cosmetic enhancement, as witnessed in rhinoplasty, tummy tucks, liposuction, and cheek and lip augmentation. That women are willing to accept the risks of breast implants is evidenced by the women who, following a problem with one of their implants, will have that implant removed and replaced by another. It is true that surgeons must be more forthright about all the possible side effects and need for future surgeries so that women can have a fully informed consent when making their decision. But after that, women need to have the right to make the decision that is best for them as discussed with their physician/surgeon.


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