Safety of breast implants

By April Cashin-Garbutt, MA (Editor)May 29 2012

Following the recent scandal, described in May 2012 by the BBC as the “PIP breast implant scandal”, (1) many women may have been put off having breast implants. But how safe exactly is breast enlargement? And how do the different methods compare?

The problem with PIP breast implants

PIP breast implants, also sold under the name of M-Implants, are silicone breast implants made by the company Poly Implant Prothese (PIP), which was based in France. (2)

In 2010 it emerged that PIP was producing their breast implants from industrial-grade silicone. This material was not suitable for making the implants as it had not been medically approved.

Instead, the implants should have been made from medical-grade silicon, which is where the silicon undergoes tests to ensure it is safe to be used in humans.(3)

The French medical device regulatory authority (AFSSAPS) questioned the implants in 2010 and raised concerns about the incidence of ruptures that they incurred. (4)

Subsequently, Europe withdrew PIP implants in March 2010 (2) and in April 2010 all non-implanted silicone gel breast implants manufactured by PIP were recalled in Australia. (5)

Dangers of silicone breast implants

Although the potential dangers of PIP implants were as a result of them being made from unapproved material; how safe actually are implants made of medical-grade silicon?

According to Professor Chris Baggoley, Chief Medical Officer for the Australian Government,(6) “all silicone gel-filled breast implants are considered high risk medical devices”.(7)

The main reason he outlines is due to the risk of rupture of implants. If an implant ruptures then the silicone it contains may be able to migrate. This can sometimes result in swollen and sore lymph nodes. (7)

The U.S. Food and Drug Administration (FDA) recommends that women obtain MRI screening for silent rupture of silicone gel-filled implants after 3 years (since implant) and every 2 years after that. (8) This is because ruptured silicone implants may not present any symptoms. (7) Consequently, the woman may not be aware that an implant has ruptured.

Although Professor Baggoley states that there is no evidence of increased breast cancer risk or connective tissue diseases; he does state that there is a small possible link between silicone breast implants and a rare cancer called Anaplastic Large Cell Lymphoma (ALCL). (7)

In addition, according to the FDA, the link between breast implants and ALCL may not be a coincidence: as ALCL tends to be located in the region immediately surrounding the implant.

Furthermore, those with ALCL and breast implants tend to exhibit a different phenotype, T-cell lymphoma, to those with ALCL and no implants, B-cell. (9)

Dangers of saline-filled breast implants

Breast augmentation can also be achieved by saline-filled breast implants. These also contain silicone; however, instead of being filled with silicone gel, they have a silicone outer shell that is filled with saline solution. This sterile solution can either be filled before or during surgery. (10)

Again, there is currently no evidence to suggest that saline-filled breast implants are linked to an increased risk of breast cancer or connective tissue disease; however, there is evidence that they may be linked to ALCL. (11)

A common complication of saline-filled breast implants is implant rupture with deflation. According to the NHS, however, a rupture in a saline implant is less harmful than a ruptured silicone gel-filled implant. This is because saline is a substance that the body can absorb – as it is essentially sterile salt water. (10)

Dangers of other types of breast implant

There are other types of breast implant. In fact there have been many different attempted methods over the years, including injecting paraffin to the breasts in the late 19^th century and transplanting fat from other parts of the body to the breasts in the early 20^th century. (12)

In recent years breast implants have also been fabricated from soya bean oil and hydrogel. These are no longer available in the UK. They were removed from the market in 1999 and 2000 respectively. (13)

Hydrogel implants were removed from the market as a precautionary move, for there were questions raised over their safety.

The Medicine and Healthcare products Regulatory Agency (MHRA) in the UK, however, has not currently recommended that those with hydrogel implants must have them removed. Moreover the MHRA are continually monitoring the situation in the light of new evidence.(13)

In contrast, the Medical Devices Agency, which was the precursor to the MHRA, has recommended that those with soya bean oil filled implants should have them removed. (10)

Consequence of breast implants: Capsular contraction

In addition to the potential dangers already outlined above, there is an unavoidable consequence of all breast implants: capsular contraction.

Capsular contraction is where scar tissue shrinks. This is a perfectly normal reaction to any foreign object in the body.

The scar tissue that you have after breast augmentation is situated around the implant itself. This means that when the scar tissue shrinks it will press upon the implant, which can cause the breast to feel hard. It also may cause some pain.

The extent of capsular contracture varies from person to person. For those in which it is severe, a surgeon may perform an operation to reduce the tightness of capsular contraction. (14)

Myths about breast implants

Despite the associated dangers of having breast implants; there are also many myths surrounding breast implants.

Firstly, many people believe flying is not advisable after having breast implants. This is because they think that flying will increase the chance of the implants rupturing. According to the NHS this is not true, for the implant will not be placed under any additional strain. (15)

You may also have heard that having breast implants means that a woman cannot breastfeed. This is again not true. There is, however, evidence to suggest that breast implants may reduce the amount of milk that a woman may be able to produce. (15)

Sources:

(1) http://www.bbc.co.uk/news/health-18064377

(2) https://www.who.int/

(3) http://www.bbc.co.uk/news/health-16391522

(4) http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-100406.htm

(5) http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120518.htm

(6) https://www.health.gov.au/

(7) https://www.fda.gov/

(8) http://www.nhs.uk/Conditions/Breast-implants/Pages/Considerations.aspx

(9) http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm258564.htm

(10) http://www.bbc.co.uk/news/magazine-17511491

(11) https://webarchive.nationalarchives.gov.uk/ukgwa/20141205174856/http://www.mhra.gov.uk/index.htm#page=DynamicListMedicines

(12) http://www.nhs.uk/Conditions/Breast-implants/Pages/Complications.aspx

(13) http://www.nhs.uk/Conditions/Breast-implants/Pages/Results.aspx